Friday, February 27, 2015 7:15:12 PM
FDA To Publish Biosimilars Labeling, Generic Opioids Guidance Later This Year
Posted 27 February 2015--By Alexander Gaffney, RAC
Click For raps.com News
US pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs.
News of the new guidance documents, which FDA anticipated will come out before the end of the year, came in an updated "Guidance Agenda" document the agency puts out each year. CDER's current list of documents now contains more than 90 guidance documents it plans to either release or finalize in the coming year.
Biosimilar Labeling
The biosimilar labeling guidance is seen by many industry watchers as particularly important, as it will need to address several critical issues essential to the approval of the US' first biosimilar products, which are already under review by CDER. In particular, FDA will need to decide what "generic" name each biosimilar product will go by. Unlike generic pharmaceutical products, which are identical copies of their chemical innovators, biosimilar drugs have inherent differences relative to the biological drug they reference.
To account for these differences—and the potential for each drug to cause slightly different side effects—some have advocated for biosimilars to contain unique suffixes to make the reporting of adverse events easier.
Industry watchers will undoubtedly be keeping a close eye on how—or whether—FDA chooses to differentiate biosimilar products from the products they reference in its upcoming guidance, Labeling for Biosimilar Biological Products.
Abuse Deterrence Guidance
A second guidance document just added to FDA's list focuses on the abuse deterrent qualities of generic opioids—long a controversial topic at the agency.
At issue: After an opioid is approved, its manufacturer often works to improve its abuse-deterrent qualities to make it harder to misuse and abuse. However, these new qualities do not necessarily extend the original drug's patent protection or marketing exclusivity. As a result, FDA may subsequently approve drugs generic to the original—i.e. non-abuse-deterrent—opioid drug.
FDA has defended this practice by saying it is up to manufacturers to prove that their new abuse-resistance measures actually live up to their claims and deter abuse, and that without such data it is under no obligation to prevent generic competition.
Some industry trade groups and legislators, meanwhile, have called on FDA to change its standards in light of the potential for these generic drugs to increase rates of abuse. In January 2015, for example, industry groups PhRMA and BIO called on the agency to hold generic opioid products to the same abuse-deterrence standards as the most recently approved abuse-deterrent opioid.
Now FDA appears poised to weigh in on the issue. Later this year, FDA will publish the guidance General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug.
Full List of Guidance Documents Planned for 2015
A full list of the guidance documents planned for 2015 may be found below. A fair warning: While FDA says it plans to get to all documents this year, in practice it rarely does.
Advertising
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs
Direct-to-Consumer Television Advertisements –DTC Television Ad Pre-Dissemination Review Program for Human Drugs
Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act
Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites
Manufacturer Communications Regarding Unapproved Uses of Approved Medical Products
Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs
Biopharmaceutics
Bioavailability and Bioequivalence Studies Submitted in NDA’s or INDs for Orally Administered Drug Products – General Considerations
Dissolution Testing and Specifications Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutical Classification System Class 1 and 3 Drugs
Food Effects Bioavailability and Fed Bioequivalence Studies
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
Biosimilarity
Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
Considerations in Demonstrating Interchangeability to a Reference Product Labeling for Biosimilar Biological Products
Labeling for Biosimilar Biological Products
Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity
Clinical/Medical
Alcoholism: Developing Drugs for Treatment
Common Issues in Drug Development for Rare Diseases
Duchenne Muscular Dystrophy and Related Dystorphinopaties: Developing Drugs for Treatment
Evaluating Drug Effects on Ability to Operate a Motor Vehicle
Exocrine Pancreatic Insufficiency Drug Products: Submitting Marketing Applications and Recommendations for Labeling
Head Lice Infestations: Developing Drugs for Treatment
Measuring Treatment Benefit in Pediatric Populations: Use of Clinical Outcome Assessments
Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
Standards for Clinical Trial Imaging Endpoints
Sunscreens: Safety and Effectiveness Data for Over-the-Counter Monograph Active Ingredients
Ulcerative Colitis: Developing Drugs for Treatment
Clinical Pharmacology
Clinical Lactation Trials – Trial Design, Data Analysis and Recommendations for Labeling
Content and Format of the Clinical Pharmacology Section of a New Drug Applications (NDA) and Biologics License Applications (BLA)
Dose Selection in Drug Development
Exposure-Response Relationships
In vitro Drug Interactions
In vivo Drug Interactions
Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling
Pharmacokinetics During Pregnancy and the Postpartum Period – Trial Design, Data Analysis, and Impact on Dosing and Labeling
Population Pharmacokinetics
Clinical/Statistical
Multiple Endpoints in Clinical Trials
Drug Safety
Content, Format and Submission of Adverse Event Reports by Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)
Safety Assessment for Expedited Reporting for IND Studies
Electronic Submissions
NDA and BLA Content for Planning and Conduct of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions
Providing Regulatory Submissions in Electronic Format – Manufacturing Establishment Information
Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards
Generics
Acceptability of Draft Package Insert Labeling to Support ANDA Approval
ANDA Submissions Refuse-to-Receive for Typographical Errors and Misplaced Files
Complete Assessments for Type II API DMFs Under GDUFA
General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug Products
Guidance for Industry on GDUFA Completeness Assessment Checklist for Type II API DMFs
Labeling
Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format
Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format
Pharmaceutical Quality/CMC
Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base
Appropriate Package Type Terms for Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use
Botanical Drug Development
Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
Development of Near Infrared Spectroscopy (NIR) Procedures
Drug Products Containing Nanomaterials
Elemental Impurities in Drug Products Marketed in the United States
Environmental Assessment: Questions and Answers Regarding Drugs with Hormonal Activity
Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products
Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling Documentation
Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing
Quality Metrics and Risk-Based Inspections
Specified Biotechnology and Specified Synthetic Biological Products – Annual Report
Pharmaceutical Quality/Manufacturing Standards (CGMP)
CGMP Data Integrity Questions and Answers
Current Good Manufacturing Practice for Outsourcing Facilities (Pharmacy Compounding)
Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities
CATEGORY – Pharmacology/Toxicology
Nonclinical Assessment of Investigational Enzyme Replacement Therapy Products
Procedural
Applying the Statutory Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS)
Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft
Critical Path Innovation Meeting
DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
DSCSA Implementation: Products Eligible for Grandfather Status
DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices
DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs
DSCSA: Verification Systems for Prescription Drugs
DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements
For Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate
Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators
Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
National Drug Code (NDC) Assignment of CDER-Regulated Products
Nonprescription Sunscreen Drug Products – Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act
Process for Withdrawal of GRASE Request or Pending Request Under the Sunscreen Innovation Act
Public Disclosure of FDA-Sponsored Studies
REMS Program Evaluation: Assessment Planning and Reporting
Special Protocol Assessment
Submission of Field Alert Reports and Biological Product Deviation Reports
Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation Strategies for Review by the Office of Generic Drugs
Sunscreen Innovation Act Review Process, Including Section 586C(c)
Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge
Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS)
Use of Electronic Informed Consent in Clinical Investigations Questions and Answers
- See more at: http://www.raps.org/Regulatory-Focus/News/2015/02/27/21584/FDA-to-Publish-Biosimilars-Labeling-Generic-Opioids-Guidance-Later-This-Year/#sthash.ePwFzjRo.dpufUS pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs.
News of the new guidance documents, which FDA anticipated will come out before the end of the year, came in an updated "Guidance Agenda" document the agency puts out each year. CDER's current list of documents now contains more than 90 guidance documents it plans to either release or finalize in the coming year.
Biosimilar Labeling
The biosimilar labeling guidance is seen by many industry watchers as particularly important, as it will need to address several critical issues essential to the approval of the US' first biosimilar products, which are already under review by CDER. In particular, FDA will need to decide what "generic" name each biosimilar product will go by. Unlike generic pharmaceutical products, which are identical copies of their chemical innovators, biosimilar drugs have inherent differences relative to the biological drug they reference.
To account for these differences—and the potential for each drug to cause slightly different side effects—some have advocated for biosimilars to contain unique suffixes to make the reporting of adverse events easier.
For more on this debate and its nuances, please see a previous article on the subject here.
Industry watchers will undoubtedly be keeping a close eye on how—or whether—FDA chooses to differentiate biosimilar products from the products they reference in its upcoming guidance, Labeling for Biosimilar Biological Products.
Abuse Deterrence Guidance
A second guidance document just added to FDA's list focuses on the abuse deterrent qualities of generic opioids—long a controversial topic at the agency.
At issue: After an opioid is approved, its manufacturer often works to improve its abuse-deterrent qualities to make it harder to misuse and abuse. However, these new qualities do not necessarily extend the original drug's patent protection or marketing exclusivity. As a result, FDA may subsequently approve drugs generic to the original—i.e. non-abuse-deterrent—opioid drug.
FDA has defended this practice by saying it is up to manufacturers to prove that their new abuse-resistance measures actually live up to their claims and deter abuse, and that without such data it is under no obligation to prevent generic competition.
Some industry trade groups and legislators, meanwhile, have called on FDA to change its standards in light of the potential for these generic drugs to increase rates of abuse. In January 2015, for example, industry groups PhRMA and BIO called on the agency to hold generic opioid products to the same abuse-deterrence standards as the most recently approved abuse-deterrent opioid.
For more on this issue, please read our previous article here.
Now FDA appears poised to weigh in on the issue. Later this year, FDA will publish the guidance General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug.
Full List of Guidance Documents Planned for 2015
A full list of the guidance documents planned for 2015 may be found below. A fair warning: While FDA says it plans to get to all documents this year, in practice it rarely does.
Advertising
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs
Direct-to-Consumer Television Advertisements –DTC Television Ad Pre-Dissemination Review Program for Human Drugs
Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act
Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites
Manufacturer Communications Regarding Unapproved Uses of Approved Medical Products
Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs
Biopharmaceutics
Bioavailability and Bioequivalence Studies Submitted in NDA’s or INDs for Orally Administered Drug Products – General Considerations
Dissolution Testing and Specifications Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutical Classification System Class 1 and 3 Drugs
Food Effects Bioavailability and Fed Bioequivalence Studies
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
Biosimilarity
Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
Considerations in Demonstrating Interchangeability to a Reference Product Labeling for Biosimilar Biological Products
Labeling for Biosimilar Biological Products
Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity
Clinical/Medical
Alcoholism: Developing Drugs for Treatment
Common Issues in Drug Development for Rare Diseases
Duchenne Muscular Dystrophy and Related Dystorphinopaties: Developing Drugs for Treatment
Evaluating Drug Effects on Ability to Operate a Motor Vehicle
Exocrine Pancreatic Insufficiency Drug Products: Submitting Marketing Applications and Recommendations for Labeling
Head Lice Infestations: Developing Drugs for Treatment
Measuring Treatment Benefit in Pediatric Populations: Use of Clinical Outcome Assessments
Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
Standards for Clinical Trial Imaging Endpoints
Sunscreens: Safety and Effectiveness Data for Over-the-Counter Monograph Active Ingredients
Ulcerative Colitis: Developing Drugs for Treatment
Clinical Pharmacology
Clinical Lactation Trials – Trial Design, Data Analysis and Recommendations for Labeling
Content and Format of the Clinical Pharmacology Section of a New Drug Applications (NDA) and Biologics License Applications (BLA)
Dose Selection in Drug Development
Exposure-Response Relationships
In vitro Drug Interactions
In vivo Drug Interactions
Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling
Pharmacokinetics During Pregnancy and the Postpartum Period – Trial Design, Data Analysis, and Impact on Dosing and Labeling
Population Pharmacokinetics
Clinical/Statistical
Multiple Endpoints in Clinical Trials
Drug Safety
Content, Format and Submission of Adverse Event Reports by Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)
Safety Assessment for Expedited Reporting for IND Studies
Electronic Submissions
NDA and BLA Content for Planning and Conduct of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions
Providing Regulatory Submissions in Electronic Format – Manufacturing Establishment Information
Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards
Generics
Acceptability of Draft Package Insert Labeling to Support ANDA Approval
ANDA Submissions Refuse-to-Receive for Typographical Errors and Misplaced Files
Complete Assessments for Type II API DMFs Under GDUFA
General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug Products
Guidance for Industry on GDUFA Completeness Assessment Checklist for Type II API DMFs
Labeling
Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format
Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format
Pharmaceutical Quality/CMC
Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base
Appropriate Package Type Terms for Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use
Botanical Drug Development
Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
Development of Near Infrared Spectroscopy (NIR) Procedures
Drug Products Containing Nanomaterials
Elemental Impurities in Drug Products Marketed in the United States
Environmental Assessment: Questions and Answers Regarding Drugs with Hormonal Activity
Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products
Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling Documentation
Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing
Quality Metrics and Risk-Based Inspections
Specified Biotechnology and Specified Synthetic Biological Products – Annual Report
Pharmaceutical Quality/Manufacturing Standards (CGMP)
CGMP Data Integrity Questions and Answers
Current Good Manufacturing Practice for Outsourcing Facilities (Pharmacy Compounding)
Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities
CATEGORY – Pharmacology/Toxicology
Nonclinical Assessment of Investigational Enzyme Replacement Therapy Products
Procedural
Applying the Statutory Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS)
Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft
Critical Path Innovation Meeting
DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
DSCSA Implementation: Products Eligible for Grandfather Status
DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices
DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs
DSCSA: Verification Systems for Prescription Drugs
DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements
For Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate
Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators
Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
National Drug Code (NDC) Assignment of CDER-Regulated Products
Nonprescription Sunscreen Drug Products – Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act
Process for Withdrawal of GRASE Request or Pending Request Under the Sunscreen Innovation Act
Public Disclosure of FDA-Sponsored Studies
REMS Program Evaluation: Assessment Planning and Reporting
Special Protocol Assessment
Submission of Field Alert Reports and Biological Product Deviation Reports
Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation Strategies for Review by the Office of Generic Drugs
Sunscreen Innovation Act Review Process, Including Section 586C(c)
Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge
Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS)
Use of Electronic Informed Consent in Clinical Investigations Questions and Answers
- See more at: http://www.raps.org/Regulatory-Focus/News/2015/02/27/21584/FDA-to-Publish-Biosimilars-Labeling-Generic-Opioids-Guidance-Later-This-Year/#sthash.ePwFzjRo.dpufUS pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs.
News of the new guidance documents, which FDA anticipated will come out before the end of the year, came in an updated "Guidance Agenda" document the agency puts out each year. CDER's current list of documents now contains more than 90 guidance documents it plans to either release or finalize in the coming year.
Biosimilar Labeling
The biosimilar labeling guidance is seen by many industry watchers as particularly important, as it will need to address several critical issues essential to the approval of the US' first biosimilar products, which are already under review by CDER. In particular, FDA will need to decide what "generic" name each biosimilar product will go by. Unlike generic pharmaceutical products, which are identical copies of their chemical innovators, biosimilar drugs have inherent differences relative to the biological drug they reference.
To account for these differences—and the potential for each drug to cause slightly different side effects—some have advocated for biosimilars to contain unique suffixes to make the reporting of adverse events easier.
For more on this debate and its nuances, please see a previous article on the subject here.
Industry watchers will undoubtedly be keeping a close eye on how—or whether—FDA chooses to differentiate biosimilar products from the products they reference in its upcoming guidance, Labeling for Biosimilar Biological Products.
Abuse Deterrence Guidance
A second guidance document just added to FDA's list focuses on the abuse deterrent qualities of generic opioids—long a controversial topic at the agency.
At issue: After an opioid is approved, its manufacturer often works to improve its abuse-deterrent qualities to make it harder to misuse and abuse. However, these new qualities do not necessarily extend the original drug's patent protection or marketing exclusivity. As a result, FDA may subsequently approve drugs generic to the original—i.e. non-abuse-deterrent—opioid drug.
FDA has defended this practice by saying it is up to manufacturers to prove that their new abuse-resistance measures actually live up to their claims and deter abuse, and that without such data it is under no obligation to prevent generic competition.
Some industry trade groups and legislators, meanwhile, have called on FDA to change its standards in light of the potential for these generic drugs to increase rates of abuse. In January 2015, for example, industry groups PhRMA and BIO called on the agency to hold generic opioid products to the same abuse-deterrence standards as the most recently approved abuse-deterrent opioid.
For more on this issue, please read our previous article here.
Now FDA appears poised to weigh in on the issue. Later this year, FDA will publish the guidance General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug.
Full List of Guidance Documents Planned for 2015
A full list of the guidance documents planned for 2015 may be found below. A fair warning: While FDA says it plans to get to all documents this year, in practice it rarely does.
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer Directed
Print Advertisements and Promotional Labeling for Human Prescription Drugs
Direct-to-Consumer Television Advertisements –DTC Television Ad Pre-Dissemination Review Program for Human Drugs
Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act
Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites
Manufacturer Communications Regarding Unapproved Uses of Approved Medical Products
Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs
Biopharmaceutics
Bioavailability and Bioequivalence Studies Submitted in NDA’s or INDs for Orally Administered Drug Products – General Considerations
Dissolution Testing and Specifications Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutical Classification System Class 1 and 3 Drugs
Food Effects Bioavailability and Fed Bioequivalence Studies
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
Biosimilarity
Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
Considerations in Demonstrating Interchangeability to a Reference Product Labeling for Biosimilar Biological Products
Labeling for Biosimilar Biological Products
Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity
Clinical/Medical
Alcoholism: Developing Drugs for Treatment
Common Issues in Drug Development for Rare Diseases
Duchenne Muscular Dystrophy and Related Dystorphinopaties: Developing Drugs for Treatment
Evaluating Drug Effects on Ability to Operate a Motor Vehicle
Exocrine Pancreatic Insufficiency Drug Products: Submitting Marketing Applications and Recommendations for Labeling
Head Lice Infestations: Developing Drugs for Treatment
Measuring Treatment Benefit in Pediatric Populations: Use of Clinical Outcome Assessments
Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
Standards for Clinical Trial Imaging Endpoints
Sunscreens: Safety and Effectiveness Data for Over-the-Counter Monograph Active Ingredients
Ulcerative Colitis: Developing Drugs for Treatment
Clinical Pharmacology
Clinical Lactation Trials – Trial Design, Data Analysis and Recommendations for Labeling
Content and Format of the Clinical Pharmacology Section of a New Drug Applications (NDA) and Biologics License Applications (BLA)
Dose Selection in Drug Development
Exposure-Response Relationships
In vitro Drug Interactions
In vivo Drug Interactions
Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling
Pharmacokinetics During Pregnancy and the Postpartum Period – Trial Design, Data Analysis, and Impact on Dosing and Labeling
Population Pharmacokinetics
Clinical/Statistical
Multiple Endpoints in Clinical Trials
Drug Safety
Content, Format and Submission of Adverse Event Reports by Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)
Safety Assessment for Expedited Reporting for IND Studies
Electronic Submissions
NDA and BLA Content for Planning and Conduct of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions
Providing Regulatory Submissions in Electronic Format – Manufacturing Establishment Information
Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards
Generics
Acceptability of Draft Package Insert Labeling to Support ANDA Approval
ANDA Submissions Refuse-to-Receive for Typographical Errors and Misplaced Files
Complete Assessments for Type II API DMFs Under GDUFA
General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug Products
Guidance for Industry on GDUFA Completeness Assessment Checklist for Type II API DMFs
Labeling
Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format
Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format
Pharmaceutical Quality/CMC
Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base
Appropriate Package Type Terms for Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use
Botanical Drug Development
Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
Development of Near Infrared Spectroscopy (NIR) Procedures
Drug Products Containing Nanomaterials
Elemental Impurities in Drug Products Marketed in the United States
Environmental Assessment: Questions and Answers Regarding Drugs with Hormonal Activity
Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products
Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling Documentation
Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing
Quality Metrics and Risk-Based Inspections
Specified Biotechnology and Specified Synthetic Biological Products – Annual Report
Pharmaceutical Quality/Manufacturing Standards (CGMP)
CGMP Data Integrity Questions and Answers
Current Good Manufacturing Practice for Outsourcing Facilities (Pharmacy Compounding)
Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities
CATEGORY – Pharmacology/Toxicology
Nonclinical Assessment of Investigational Enzyme Replacement Therapy Products
Procedural
Applying the Statutory Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS)
Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft
Critical Path Innovation Meeting
DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
DSCSA Implementation: Products Eligible for Grandfather Status
DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices
DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs
DSCSA: Verification Systems for Prescription Drugs
DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements
For Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate
Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators
Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
National Drug Code (NDC) Assignment of CDER-Regulated Products
Nonprescription Sunscreen Drug Products – Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act
Process for Withdrawal of GRASE Request or Pending Request Under the Sunscreen Innovation Act
Public Disclosure of FDA-Sponsored Studies
REMS Program Evaluation: Assessment Planning and Reporting
Special Protocol Assessment
Submission of Field Alert Reports and Biological Product Deviation Reports
Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation Strategies for Review by the Office of Generic Drugs
Sunscreen Innovation Act Review Process, Including Section 586C(c)
Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge
Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS)
Use of Electronic Informed Consent in Clinical Investigations Questions and Answers
TRUTH
Posted 27 February 2015--By Alexander Gaffney, RAC
Click For raps.com News
US pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs.
News of the new guidance documents, which FDA anticipated will come out before the end of the year, came in an updated "Guidance Agenda" document the agency puts out each year. CDER's current list of documents now contains more than 90 guidance documents it plans to either release or finalize in the coming year.
Biosimilar Labeling
The biosimilar labeling guidance is seen by many industry watchers as particularly important, as it will need to address several critical issues essential to the approval of the US' first biosimilar products, which are already under review by CDER. In particular, FDA will need to decide what "generic" name each biosimilar product will go by. Unlike generic pharmaceutical products, which are identical copies of their chemical innovators, biosimilar drugs have inherent differences relative to the biological drug they reference.
To account for these differences—and the potential for each drug to cause slightly different side effects—some have advocated for biosimilars to contain unique suffixes to make the reporting of adverse events easier.
Industry watchers will undoubtedly be keeping a close eye on how—or whether—FDA chooses to differentiate biosimilar products from the products they reference in its upcoming guidance, Labeling for Biosimilar Biological Products.
Abuse Deterrence Guidance
A second guidance document just added to FDA's list focuses on the abuse deterrent qualities of generic opioids—long a controversial topic at the agency.
At issue: After an opioid is approved, its manufacturer often works to improve its abuse-deterrent qualities to make it harder to misuse and abuse. However, these new qualities do not necessarily extend the original drug's patent protection or marketing exclusivity. As a result, FDA may subsequently approve drugs generic to the original—i.e. non-abuse-deterrent—opioid drug.
FDA has defended this practice by saying it is up to manufacturers to prove that their new abuse-resistance measures actually live up to their claims and deter abuse, and that without such data it is under no obligation to prevent generic competition.
Some industry trade groups and legislators, meanwhile, have called on FDA to change its standards in light of the potential for these generic drugs to increase rates of abuse. In January 2015, for example, industry groups PhRMA and BIO called on the agency to hold generic opioid products to the same abuse-deterrence standards as the most recently approved abuse-deterrent opioid.
Now FDA appears poised to weigh in on the issue. Later this year, FDA will publish the guidance General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug.
Full List of Guidance Documents Planned for 2015
A full list of the guidance documents planned for 2015 may be found below. A fair warning: While FDA says it plans to get to all documents this year, in practice it rarely does.
Advertising
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs
Direct-to-Consumer Television Advertisements –DTC Television Ad Pre-Dissemination Review Program for Human Drugs
Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act
Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites
Manufacturer Communications Regarding Unapproved Uses of Approved Medical Products
Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs
Biopharmaceutics
Bioavailability and Bioequivalence Studies Submitted in NDA’s or INDs for Orally Administered Drug Products – General Considerations
Dissolution Testing and Specifications Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutical Classification System Class 1 and 3 Drugs
Food Effects Bioavailability and Fed Bioequivalence Studies
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
Biosimilarity
Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
Considerations in Demonstrating Interchangeability to a Reference Product Labeling for Biosimilar Biological Products
Labeling for Biosimilar Biological Products
Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity
Clinical/Medical
Alcoholism: Developing Drugs for Treatment
Common Issues in Drug Development for Rare Diseases
Duchenne Muscular Dystrophy and Related Dystorphinopaties: Developing Drugs for Treatment
Evaluating Drug Effects on Ability to Operate a Motor Vehicle
Exocrine Pancreatic Insufficiency Drug Products: Submitting Marketing Applications and Recommendations for Labeling
Head Lice Infestations: Developing Drugs for Treatment
Measuring Treatment Benefit in Pediatric Populations: Use of Clinical Outcome Assessments
Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
Standards for Clinical Trial Imaging Endpoints
Sunscreens: Safety and Effectiveness Data for Over-the-Counter Monograph Active Ingredients
Ulcerative Colitis: Developing Drugs for Treatment
Clinical Pharmacology
Clinical Lactation Trials – Trial Design, Data Analysis and Recommendations for Labeling
Content and Format of the Clinical Pharmacology Section of a New Drug Applications (NDA) and Biologics License Applications (BLA)
Dose Selection in Drug Development
Exposure-Response Relationships
In vitro Drug Interactions
In vivo Drug Interactions
Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling
Pharmacokinetics During Pregnancy and the Postpartum Period – Trial Design, Data Analysis, and Impact on Dosing and Labeling
Population Pharmacokinetics
Clinical/Statistical
Multiple Endpoints in Clinical Trials
Drug Safety
Content, Format and Submission of Adverse Event Reports by Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)
Safety Assessment for Expedited Reporting for IND Studies
Electronic Submissions
NDA and BLA Content for Planning and Conduct of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions
Providing Regulatory Submissions in Electronic Format – Manufacturing Establishment Information
Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards
Generics
Acceptability of Draft Package Insert Labeling to Support ANDA Approval
ANDA Submissions Refuse-to-Receive for Typographical Errors and Misplaced Files
Complete Assessments for Type II API DMFs Under GDUFA
General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug Products
Guidance for Industry on GDUFA Completeness Assessment Checklist for Type II API DMFs
Labeling
Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format
Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format
Pharmaceutical Quality/CMC
Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base
Appropriate Package Type Terms for Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use
Botanical Drug Development
Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
Development of Near Infrared Spectroscopy (NIR) Procedures
Drug Products Containing Nanomaterials
Elemental Impurities in Drug Products Marketed in the United States
Environmental Assessment: Questions and Answers Regarding Drugs with Hormonal Activity
Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products
Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling Documentation
Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing
Quality Metrics and Risk-Based Inspections
Specified Biotechnology and Specified Synthetic Biological Products – Annual Report
Pharmaceutical Quality/Manufacturing Standards (CGMP)
CGMP Data Integrity Questions and Answers
Current Good Manufacturing Practice for Outsourcing Facilities (Pharmacy Compounding)
Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities
CATEGORY – Pharmacology/Toxicology
Nonclinical Assessment of Investigational Enzyme Replacement Therapy Products
Procedural
Applying the Statutory Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS)
Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft
Critical Path Innovation Meeting
DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
DSCSA Implementation: Products Eligible for Grandfather Status
DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices
DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs
DSCSA: Verification Systems for Prescription Drugs
DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements
For Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate
Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators
Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
National Drug Code (NDC) Assignment of CDER-Regulated Products
Nonprescription Sunscreen Drug Products – Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act
Process for Withdrawal of GRASE Request or Pending Request Under the Sunscreen Innovation Act
Public Disclosure of FDA-Sponsored Studies
REMS Program Evaluation: Assessment Planning and Reporting
Special Protocol Assessment
Submission of Field Alert Reports and Biological Product Deviation Reports
Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation Strategies for Review by the Office of Generic Drugs
Sunscreen Innovation Act Review Process, Including Section 586C(c)
Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge
Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS)
Use of Electronic Informed Consent in Clinical Investigations Questions and Answers
- See more at: http://www.raps.org/Regulatory-Focus/News/2015/02/27/21584/FDA-to-Publish-Biosimilars-Labeling-Generic-Opioids-Guidance-Later-This-Year/#sthash.ePwFzjRo.dpufUS pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs.
News of the new guidance documents, which FDA anticipated will come out before the end of the year, came in an updated "Guidance Agenda" document the agency puts out each year. CDER's current list of documents now contains more than 90 guidance documents it plans to either release or finalize in the coming year.
Biosimilar Labeling
The biosimilar labeling guidance is seen by many industry watchers as particularly important, as it will need to address several critical issues essential to the approval of the US' first biosimilar products, which are already under review by CDER. In particular, FDA will need to decide what "generic" name each biosimilar product will go by. Unlike generic pharmaceutical products, which are identical copies of their chemical innovators, biosimilar drugs have inherent differences relative to the biological drug they reference.
To account for these differences—and the potential for each drug to cause slightly different side effects—some have advocated for biosimilars to contain unique suffixes to make the reporting of adverse events easier.
For more on this debate and its nuances, please see a previous article on the subject here.
Industry watchers will undoubtedly be keeping a close eye on how—or whether—FDA chooses to differentiate biosimilar products from the products they reference in its upcoming guidance, Labeling for Biosimilar Biological Products.
Abuse Deterrence Guidance
A second guidance document just added to FDA's list focuses on the abuse deterrent qualities of generic opioids—long a controversial topic at the agency.
At issue: After an opioid is approved, its manufacturer often works to improve its abuse-deterrent qualities to make it harder to misuse and abuse. However, these new qualities do not necessarily extend the original drug's patent protection or marketing exclusivity. As a result, FDA may subsequently approve drugs generic to the original—i.e. non-abuse-deterrent—opioid drug.
FDA has defended this practice by saying it is up to manufacturers to prove that their new abuse-resistance measures actually live up to their claims and deter abuse, and that without such data it is under no obligation to prevent generic competition.
Some industry trade groups and legislators, meanwhile, have called on FDA to change its standards in light of the potential for these generic drugs to increase rates of abuse. In January 2015, for example, industry groups PhRMA and BIO called on the agency to hold generic opioid products to the same abuse-deterrence standards as the most recently approved abuse-deterrent opioid.
For more on this issue, please read our previous article here.
Now FDA appears poised to weigh in on the issue. Later this year, FDA will publish the guidance General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug.
Full List of Guidance Documents Planned for 2015
A full list of the guidance documents planned for 2015 may be found below. A fair warning: While FDA says it plans to get to all documents this year, in practice it rarely does.
Advertising
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs
Direct-to-Consumer Television Advertisements –DTC Television Ad Pre-Dissemination Review Program for Human Drugs
Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act
Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites
Manufacturer Communications Regarding Unapproved Uses of Approved Medical Products
Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs
Biopharmaceutics
Bioavailability and Bioequivalence Studies Submitted in NDA’s or INDs for Orally Administered Drug Products – General Considerations
Dissolution Testing and Specifications Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutical Classification System Class 1 and 3 Drugs
Food Effects Bioavailability and Fed Bioequivalence Studies
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
Biosimilarity
Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
Considerations in Demonstrating Interchangeability to a Reference Product Labeling for Biosimilar Biological Products
Labeling for Biosimilar Biological Products
Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity
Clinical/Medical
Alcoholism: Developing Drugs for Treatment
Common Issues in Drug Development for Rare Diseases
Duchenne Muscular Dystrophy and Related Dystorphinopaties: Developing Drugs for Treatment
Evaluating Drug Effects on Ability to Operate a Motor Vehicle
Exocrine Pancreatic Insufficiency Drug Products: Submitting Marketing Applications and Recommendations for Labeling
Head Lice Infestations: Developing Drugs for Treatment
Measuring Treatment Benefit in Pediatric Populations: Use of Clinical Outcome Assessments
Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
Standards for Clinical Trial Imaging Endpoints
Sunscreens: Safety and Effectiveness Data for Over-the-Counter Monograph Active Ingredients
Ulcerative Colitis: Developing Drugs for Treatment
Clinical Pharmacology
Clinical Lactation Trials – Trial Design, Data Analysis and Recommendations for Labeling
Content and Format of the Clinical Pharmacology Section of a New Drug Applications (NDA) and Biologics License Applications (BLA)
Dose Selection in Drug Development
Exposure-Response Relationships
In vitro Drug Interactions
In vivo Drug Interactions
Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling
Pharmacokinetics During Pregnancy and the Postpartum Period – Trial Design, Data Analysis, and Impact on Dosing and Labeling
Population Pharmacokinetics
Clinical/Statistical
Multiple Endpoints in Clinical Trials
Drug Safety
Content, Format and Submission of Adverse Event Reports by Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)
Safety Assessment for Expedited Reporting for IND Studies
Electronic Submissions
NDA and BLA Content for Planning and Conduct of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions
Providing Regulatory Submissions in Electronic Format – Manufacturing Establishment Information
Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards
Generics
Acceptability of Draft Package Insert Labeling to Support ANDA Approval
ANDA Submissions Refuse-to-Receive for Typographical Errors and Misplaced Files
Complete Assessments for Type II API DMFs Under GDUFA
General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug Products
Guidance for Industry on GDUFA Completeness Assessment Checklist for Type II API DMFs
Labeling
Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format
Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format
Pharmaceutical Quality/CMC
Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base
Appropriate Package Type Terms for Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use
Botanical Drug Development
Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
Development of Near Infrared Spectroscopy (NIR) Procedures
Drug Products Containing Nanomaterials
Elemental Impurities in Drug Products Marketed in the United States
Environmental Assessment: Questions and Answers Regarding Drugs with Hormonal Activity
Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products
Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling Documentation
Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing
Quality Metrics and Risk-Based Inspections
Specified Biotechnology and Specified Synthetic Biological Products – Annual Report
Pharmaceutical Quality/Manufacturing Standards (CGMP)
CGMP Data Integrity Questions and Answers
Current Good Manufacturing Practice for Outsourcing Facilities (Pharmacy Compounding)
Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities
CATEGORY – Pharmacology/Toxicology
Nonclinical Assessment of Investigational Enzyme Replacement Therapy Products
Procedural
Applying the Statutory Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS)
Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft
Critical Path Innovation Meeting
DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
DSCSA Implementation: Products Eligible for Grandfather Status
DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices
DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs
DSCSA: Verification Systems for Prescription Drugs
DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements
For Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate
Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators
Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
National Drug Code (NDC) Assignment of CDER-Regulated Products
Nonprescription Sunscreen Drug Products – Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act
Process for Withdrawal of GRASE Request or Pending Request Under the Sunscreen Innovation Act
Public Disclosure of FDA-Sponsored Studies
REMS Program Evaluation: Assessment Planning and Reporting
Special Protocol Assessment
Submission of Field Alert Reports and Biological Product Deviation Reports
Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation Strategies for Review by the Office of Generic Drugs
Sunscreen Innovation Act Review Process, Including Section 586C(c)
Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge
Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS)
Use of Electronic Informed Consent in Clinical Investigations Questions and Answers
- See more at: http://www.raps.org/Regulatory-Focus/News/2015/02/27/21584/FDA-to-Publish-Biosimilars-Labeling-Generic-Opioids-Guidance-Later-This-Year/#sthash.ePwFzjRo.dpufUS pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs.
News of the new guidance documents, which FDA anticipated will come out before the end of the year, came in an updated "Guidance Agenda" document the agency puts out each year. CDER's current list of documents now contains more than 90 guidance documents it plans to either release or finalize in the coming year.
Biosimilar Labeling
The biosimilar labeling guidance is seen by many industry watchers as particularly important, as it will need to address several critical issues essential to the approval of the US' first biosimilar products, which are already under review by CDER. In particular, FDA will need to decide what "generic" name each biosimilar product will go by. Unlike generic pharmaceutical products, which are identical copies of their chemical innovators, biosimilar drugs have inherent differences relative to the biological drug they reference.
To account for these differences—and the potential for each drug to cause slightly different side effects—some have advocated for biosimilars to contain unique suffixes to make the reporting of adverse events easier.
For more on this debate and its nuances, please see a previous article on the subject here.
Industry watchers will undoubtedly be keeping a close eye on how—or whether—FDA chooses to differentiate biosimilar products from the products they reference in its upcoming guidance, Labeling for Biosimilar Biological Products.
Abuse Deterrence Guidance
A second guidance document just added to FDA's list focuses on the abuse deterrent qualities of generic opioids—long a controversial topic at the agency.
At issue: After an opioid is approved, its manufacturer often works to improve its abuse-deterrent qualities to make it harder to misuse and abuse. However, these new qualities do not necessarily extend the original drug's patent protection or marketing exclusivity. As a result, FDA may subsequently approve drugs generic to the original—i.e. non-abuse-deterrent—opioid drug.
FDA has defended this practice by saying it is up to manufacturers to prove that their new abuse-resistance measures actually live up to their claims and deter abuse, and that without such data it is under no obligation to prevent generic competition.
Some industry trade groups and legislators, meanwhile, have called on FDA to change its standards in light of the potential for these generic drugs to increase rates of abuse. In January 2015, for example, industry groups PhRMA and BIO called on the agency to hold generic opioid products to the same abuse-deterrence standards as the most recently approved abuse-deterrent opioid.
For more on this issue, please read our previous article here.
Now FDA appears poised to weigh in on the issue. Later this year, FDA will publish the guidance General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug.
Full List of Guidance Documents Planned for 2015
A full list of the guidance documents planned for 2015 may be found below. A fair warning: While FDA says it plans to get to all documents this year, in practice it rarely does.
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer Directed
Print Advertisements and Promotional Labeling for Human Prescription Drugs
Direct-to-Consumer Television Advertisements –DTC Television Ad Pre-Dissemination Review Program for Human Drugs
Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act
Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites
Manufacturer Communications Regarding Unapproved Uses of Approved Medical Products
Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs
Biopharmaceutics
Bioavailability and Bioequivalence Studies Submitted in NDA’s or INDs for Orally Administered Drug Products – General Considerations
Dissolution Testing and Specifications Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutical Classification System Class 1 and 3 Drugs
Food Effects Bioavailability and Fed Bioequivalence Studies
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
Biosimilarity
Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
Considerations in Demonstrating Interchangeability to a Reference Product Labeling for Biosimilar Biological Products
Labeling for Biosimilar Biological Products
Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity
Clinical/Medical
Alcoholism: Developing Drugs for Treatment
Common Issues in Drug Development for Rare Diseases
Duchenne Muscular Dystrophy and Related Dystorphinopaties: Developing Drugs for Treatment
Evaluating Drug Effects on Ability to Operate a Motor Vehicle
Exocrine Pancreatic Insufficiency Drug Products: Submitting Marketing Applications and Recommendations for Labeling
Head Lice Infestations: Developing Drugs for Treatment
Measuring Treatment Benefit in Pediatric Populations: Use of Clinical Outcome Assessments
Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
Standards for Clinical Trial Imaging Endpoints
Sunscreens: Safety and Effectiveness Data for Over-the-Counter Monograph Active Ingredients
Ulcerative Colitis: Developing Drugs for Treatment
Clinical Pharmacology
Clinical Lactation Trials – Trial Design, Data Analysis and Recommendations for Labeling
Content and Format of the Clinical Pharmacology Section of a New Drug Applications (NDA) and Biologics License Applications (BLA)
Dose Selection in Drug Development
Exposure-Response Relationships
In vitro Drug Interactions
In vivo Drug Interactions
Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling
Pharmacokinetics During Pregnancy and the Postpartum Period – Trial Design, Data Analysis, and Impact on Dosing and Labeling
Population Pharmacokinetics
Clinical/Statistical
Multiple Endpoints in Clinical Trials
Drug Safety
Content, Format and Submission of Adverse Event Reports by Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)
Safety Assessment for Expedited Reporting for IND Studies
Electronic Submissions
NDA and BLA Content for Planning and Conduct of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions
Providing Regulatory Submissions in Electronic Format – Manufacturing Establishment Information
Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards
Generics
Acceptability of Draft Package Insert Labeling to Support ANDA Approval
ANDA Submissions Refuse-to-Receive for Typographical Errors and Misplaced Files
Complete Assessments for Type II API DMFs Under GDUFA
General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug Products
Guidance for Industry on GDUFA Completeness Assessment Checklist for Type II API DMFs
Labeling
Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format
Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format
Pharmaceutical Quality/CMC
Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base
Appropriate Package Type Terms for Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use
Botanical Drug Development
Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
Development of Near Infrared Spectroscopy (NIR) Procedures
Drug Products Containing Nanomaterials
Elemental Impurities in Drug Products Marketed in the United States
Environmental Assessment: Questions and Answers Regarding Drugs with Hormonal Activity
Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products
Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling Documentation
Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing
Quality Metrics and Risk-Based Inspections
Specified Biotechnology and Specified Synthetic Biological Products – Annual Report
Pharmaceutical Quality/Manufacturing Standards (CGMP)
CGMP Data Integrity Questions and Answers
Current Good Manufacturing Practice for Outsourcing Facilities (Pharmacy Compounding)
Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities
CATEGORY – Pharmacology/Toxicology
Nonclinical Assessment of Investigational Enzyme Replacement Therapy Products
Procedural
Applying the Statutory Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS)
Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft
Critical Path Innovation Meeting
DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
DSCSA Implementation: Products Eligible for Grandfather Status
DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices
DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs
DSCSA: Verification Systems for Prescription Drugs
DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements
For Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate
Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators
Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
National Drug Code (NDC) Assignment of CDER-Regulated Products
Nonprescription Sunscreen Drug Products – Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act
Process for Withdrawal of GRASE Request or Pending Request Under the Sunscreen Innovation Act
Public Disclosure of FDA-Sponsored Studies
REMS Program Evaluation: Assessment Planning and Reporting
Special Protocol Assessment
Submission of Field Alert Reports and Biological Product Deviation Reports
Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation Strategies for Review by the Office of Generic Drugs
Sunscreen Innovation Act Review Process, Including Section 586C(c)
Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge
Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS)
Use of Electronic Informed Consent in Clinical Investigations Questions and Answers
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