Friday, October 20, 2017 8:36:23 AM
don't focus on the tree!!!
"A drug that receives Fast Track designation is eligible for some or all of the following:
•More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
•More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
•Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
•Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
Recent CYTH News
- Cyclo Therapeutics Presents Encouraging Preliminary Safety Data from Ongoing Pivotal Phase 3 Study and Substudy for the Treatment of Niemann-Pick Disease Type C1 (NPC1) • Business Wire • 09/05/2024 01:05:00 PM
- Kuehn Law Encourages CYTH, ARCH, CEIX, and VGR Investors to Contact Law Firm • PR Newswire (US) • 08/26/2024 01:37:00 PM
- Form 425 - Prospectuses and communications, business combinations • Edgar (US Regulatory) • 08/22/2024 01:37:04 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/22/2024 01:36:40 PM
- Rafael Holdings and Cyclo Therapeutics Enter Into a Definitive Merger Agreement • Business Wire • 08/22/2024 10:50:00 AM
- Rafael Holdings and Cyclo Therapeutics Enter into a Definitive Merger Agreement • GlobeNewswire Inc. • 08/22/2024 10:50:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/20/2024 05:50:50 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/20/2024 05:49:54 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/20/2024 05:49:29 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/20/2024 05:49:08 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/20/2024 05:48:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/20/2024 05:48:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/20/2024 05:47:47 PM
- Cyclo Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update • Business Wire • 08/15/2024 01:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 09:28:23 PM
- Cyclo Therapeutics Announces Notice of Decision to Grant European Patent Application for Treatment of Alzheimer’s Disease from European Patent Office • Business Wire • 07/29/2024 01:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/17/2024 06:35:02 PM
- Cyclo Therapeutics to Present at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2024 • Business Wire • 06/25/2024 01:25:00 PM
- Rafael Holdings Reports Third Quarter Fiscal 2024 Financial Results • GlobeNewswire Inc. • 06/14/2024 08:01:00 PM
- Cyclo Therapeutics Achieves Landmark Milestone with Completion of Enrollment of Last Patient in Phase 3 Pivotal TransportNPC™ Trial of Niemann-Pick Type C1 • Business Wire • 05/30/2024 01:00:00 PM
- Cyclo Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update • Business Wire • 05/16/2024 12:05:00 PM
- Cyclo Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update • Business Wire • 03/18/2024 01:05:00 PM
- Cyclo Therapeutics Announces Issuance of U.S. Patent Covering the Use of Trappsol® Cyclo™ for the Treatment of Alzheimer’s Disease • Business Wire • 03/14/2024 01:34:00 PM
- Rafael Holdings Reports Second Quarter Fiscal 2024 Financial Results • GlobeNewswire Inc. • 03/13/2024 09:04:24 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 03/04/2024 09:33:34 PM
FEATURED Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • Sep 24, 2024 8:50 AM
FEATURED Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • Sep 24, 2024 8:45 AM
Avant Technologies Accelerates Creation of AI-Powered Platform to Revolutionize Patient Care • AVAI • Sep 24, 2024 8:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM