Generic Drug Submissions

Question 0

Drug Efficacy Amendments of 1962

Answer 0

First generic drugs were marketed between FD&C Act of 1938 and this Amendment. This Amendment requires the sponsor to submit an ANDA

Question 1

Federal Food Drug and Cosmetic Act of 1938

Answer 1

Does not define “generic drug”

Question 2

Drug Regulation Reform Act of 1978

Answer 2

a

Question 3

Drug Price Competition and Patent Term Restoration Act of 1984

Answer 3

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.

Question 4

Medicare Prescription Dug, Improvement, ad Modernization Act of 2003

Answer 4

Amended FD&C Act to preclude a generic applicant with a pending ANDA from amending its application to change the RLD.

Question 5

Prescription Drug User Fee Act of 1992

Answer 5

a

Question 6

Pediatric Research Equity Act of 2003

Answer 6

a

Question 7

Generic Drug User Fee Amendments of 2012

Answer 7

Has much lower fees than through PDUFA around $51K vs. 526K.

Question 8

21 CFR 314

Answer 8

Applications for FDA Approval to Market a New Drug

Question 9

21 CFR 320

Answer 9

Bioavailability and BieEquivalence Requirements

Question 10

43 Fed. Reg. 39,126 (1 Sept 1978)

Answer 10

Abbreviated New Drug Applications; Proposed Related Drug Amendments

Question 11

44 Fed. Reg. 2932 (12 Jan 1979)

Answer 11

Therapeutically Equivalent Drugs; Availability of List

Question 12

45 Fed. Reg. 72,582 (31 Oct 1980)

Answer 12

Therapeutically Equivalent Drugs; Availability of List

Question 13

45 Fed. Reg. 82,052 (12 Dec 1980)

Answer 13

Response to Petition Seeking Withdrawal of the Policy Described in the Agency’s “Paper” NDA Memorandum of 31 July 1978

Question 14

46 Fed. Reg. 27,396 (19 May 1981)

Answer 14

Publication of “Paper NDA” Memorandum

Question 15

54 Fed. Reg. 28,872 (10 July 1989)

Answer 15

Proposed ANDA Regulations

Question 16

74 Fed. Reg. 2849 (16 Jan 2009)

Answer 16

Requirements for submission of Bioequivalence data

Question 17

ANDA

Answer 17

An ANDA drug must use the same active ingredient, and have essentially the same labeling, including indications, warnings, contraindications, etc. as the branded drug. Can have different: route of administration, dosage form and strength as well as in a single active ingredient in a combination drug product if the branded drug was originally approved that way.

Question 18

Pediatric Research Equity Act 2003

Answer 18

PREA - Allows FDA to require a sponsor who applies or supplements a new active ingredient, new indication, new dosage form, dong regimen, or route of administration shall submit results of pediatric studies assessing safety and effectiveness for the claims in all relevant pediatric subpopulations and to support the dosing and administration.