Generic Drug Submissions Flashcards

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0
Q

Drug Efficacy Amendments of 1962

A

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

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1
Q

Federal Food Drug and Cosmetic Act of 1938

A

Does not define “generic drug”

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2
Q

Drug Regulation Reform Act of 1978

A

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3
Q

Drug Price Competition and Patent Term Restoration Act of 1984

A

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.

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4
Q

Medicare Prescription Dug, Improvement, ad Modernization Act of 2003

A

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

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5
Q

Prescription Drug User Fee Act of 1992

A

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6
Q

Pediatric Research Equity Act of 2003

A

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7
Q

Generic Drug User Fee Amendments of 2012

A

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

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8
Q

21 CFR 314

A

Applications for FDA Approval to Market a New Drug

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9
Q

21 CFR 320

A

Bioavailability and BieEquivalence Requirements

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10
Q

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

A

Abbreviated New Drug Applications; Proposed Related Drug Amendments

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11
Q

44 Fed. Reg. 2932 (12 Jan 1979)

A

Therapeutically Equivalent Drugs; Availability of List

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12
Q

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

A

Therapeutically Equivalent Drugs; Availability of List

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13
Q

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

A

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

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14
Q

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

A

Publication of “Paper NDA” Memorandum

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15
Q

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

A

Proposed ANDA Regulations

16
Q

74 Fed. Reg. 2849 (16 Jan 2009)

A

Requirements for submission of Bioequivalence data

17
Q

ANDA

A

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.

18
Q

Pediatric Research Equity Act 2003

A

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.