Generic Drug Submissions Flashcards
Drug Efficacy Amendments of 1962
First generic drugs were marketed between FD&C Act of 1938 and this Amendment. This Amendment requires the sponsor to submit an ANDA
Federal Food Drug and Cosmetic Act of 1938
Does not define “generic drug”
Drug Regulation Reform Act of 1978
a
Drug Price Competition and Patent Term Restoration Act of 1984
Hatch-Waxman Act - Added section 505(j) which provided legal structure for generic drugs, for an ANDA containing Bioequivalence data to a band drug - the “Reference Listed Drug” (RLD) - among other data and info was sufficient for FDA to consider approval. also allowed for patent extension up to 5 years for lost time during review.
Medicare Prescription Dug, Improvement, ad Modernization Act of 2003
Amended FD&C Act to preclude a generic applicant with a pending ANDA from amending its application to change the RLD.
Prescription Drug User Fee Act of 1992
a
Pediatric Research Equity Act of 2003
a
Generic Drug User Fee Amendments of 2012
Has much lower fees than through PDUFA around $51K vs. 526K.
21 CFR 314
Applications for FDA Approval to Market a New Drug
21 CFR 320
Bioavailability and BieEquivalence Requirements
43 Fed. Reg. 39,126 (1 Sept 1978)
Abbreviated New Drug Applications; Proposed Related Drug Amendments
44 Fed. Reg. 2932 (12 Jan 1979)
Therapeutically Equivalent Drugs; Availability of List
45 Fed. Reg. 72,582 (31 Oct 1980)
Therapeutically Equivalent Drugs; Availability of List
45 Fed. Reg. 82,052 (12 Dec 1980)
Response to Petition Seeking Withdrawal of the Policy Described in the Agency’s “Paper” NDA Memorandum of 31 July 1978
46 Fed. Reg. 27,396 (19 May 1981)
Publication of “Paper NDA” Memorandum