Elite Pharmaceuticals Inc (ELTP)

[mrwrn2010]

Some 2016 info I posted and gathered from my own and others’ DD:

Re: RLSJ84 Post# 215531

https://www.gpo.gov/fdsys/pkg/FR-2008-07-10/pdf/E8-15608.pdf

TABLE 1.—SUMMARY OF CHANGES REGARDING SUBSTITUTION OF COMPLETE RESPONSE LETTERS FOR APPROVABLE AND
NOT APPROVABLE LETTERS

Complete Response Letter
• States that FDA will not approve NDA or ANDA in its present form.
• Describes all specific deficiencies that FDA has identified in the application
(except when the agency determines that data submitted
are inadequate to support approval and issues a complete response
letter without first conducting required inspection and/or reviewing labeling).
Deficiencies could be minor (e.g., requiring labeling
changes) or major (e.g., requiring additional clinical trials).
• Reflects complete review of data in NDA or ANDA and any amendments
FDA has reviewed.
• When possible, recommends actions applicant might take to place
application in condition for approval.


TABLE 2.—SUMMARY OF CHANGES TO REGULATIONS REGARDING APPLICANT’S RESPONSE TO AGENCY ACTION LETTERS

NDA or ANDA Applicant’s Response to Complete Response Letter
Review period is extended until applicant takes one of following actions:

• Resubmit NDA or ANDA, addressing identified deficiencies.
—Class 1 resubmission of NDA or efficacy supplement starts new 2-
month review cycle
—Class 2 resubmission of NDA or efficacy supplement starts new 6-
month cycle
—Resubmission of NDA supplement other than efficacy supplement
starts new cycle same length as initial review cycle for supplement
(excluding any extension due to major amendment)
—Major resubmission of ANDA or ANDA supplement starts new 6-
month cycle
—Minor resubmission of ANDA or ANDA supplement starts new cycle
of variable length
• Withdraw NDA or ANDA.
• Request opportunity for hearing.
FDA may consider failure to take action within 1 year to be request to
withdraw, unless applicant has requested extension of time in which
to resubmit.




http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM082002.pdf



Applicant submits a response to a Complete Response Letter (CRL)
FDA determines whether or not the response is complete and responds in a letter to the applicant within 30 calendar days
If FDA determines the response is NOT complete CDER so informs the applicant and the review clock does not start until a complete response is received.
If FDA determines that the response is complete, it will be classified as Class 1 or Class 2
If the CRL is classified as a Class 1, CDER will complete the review and act on the application within 2 months of the receipt date
A Class 1 classification includes
Final printed labeling
Draft labeling
Safety updates submitted in the same format, including tabulations, as the original safety submission with new data and changes highlighted (except when large amounts of new information, including important new adverse experiences, not previously reported with the product are presented in the resubmission)
Stability updates to support provisional or final dating periods
Discussions of postmarketing requirements/commitments, including proposals or protocols for such requirements/commitments
Assay validation data
Final release testing on the last 1 to 2 lots used to support approval
A minor re-analysis of data previously submitted to the application (determined by CDER as fitting the Class 1 category)
Other minor clarifying information (determined by CDER as fitting the Class 1 category)
If the CRL is classified as a Class 2, CDER will complete the review and act on the application within 6 months of the receipt date
A Class 2 resubmission includes any item not specified as a Class 1 item, including any item that would require a presentation to an advisory committee. A resubmission that requires a reinspection also would be a Class 2 resubmission.