Prescription Drug Product Submissions

Question 0

Public Health Service Act of 1944

Answer 0

a

Question 1

Federal Food, Drug, and Cosmetic Act of 1938

Answer 1

a

Question 2

Drug Price Competition and Patent Term Restoration Act of 1984

Answer 2

Hatch-Waxman Act -

Question 3

Prescription Drug Marketing Act of 1987

Answer 3

a

Question 4

Prescription Drug User Fee Act of 1992

Answer 4

PDUFA

Question 5

Federal Advisory Committee Act of 1972

Answer 5

a

Question 6

Food and Drug Administration Modernization Act of 1997

Answer 6

FDAMA

Question 7

Food and Drug Administration Amendments Act of 2007

Answer 7

FDAAA - If FDA becomes aware of new safety information about a serious risk associated with a drug’s use, the agency can require a manufacturer to implement safety labeling changes, conduct postmarketig studies or clinical trials, or establish Risk Evaluation and Mitigation Strategies (REMS)

Question 8

Food and Drug Administration Safety and Innovation Act of 2012

Answer 8

FDASIA

Question 9

21 CFR 314

Answer 9

Applications for FDA approval to market a new drug

Question 10

21 CFR 601

Answer 10

Licensing (biological products)

Question 11

Target Product Profile

Answer 11

TPP - is a format for a summary of the drug development program described in term of labeling concepts. It is prepared by the sponsor and submission is voluntary. It links each specific labeling concept to a specific study or other source of data that is intended to support the labeling concept.

Question 12

Drug Development Tools

Answer 12

DDT - animal models, biological marker and clinical outcomes assessments (COAs)

Question 13

Breakthrough Therapy Designation

Answer 13

FDASIA made available to expedite the development of therapies that show substantial promise in early clinical trials. Drug needs to be for a serious and life-threatening disease, and preliminary clinical evidence shows the drug may offer substantial improvement over existing therapies.

Question 14

Priority Review

Answer 14

Given to drugs that offer major advances in treatment, or provide treatment where no adequate therapy exists. FDA reviews more quickly than standard applications. Fast Track are also eligible for Priority Review but does not automatically convey a Priority Reivew. Applicant must request it

Question 15

Accelerated Approval

Answer 15

21 CFR 314 Subpart H (drugs) Subpart E (Biologics) - Created in 1992. Allows approval of rugs based on surrogate end-points that are reasonably likely to predict clinical benefit under these conditions 1) The disease must be serious or life-threatening 2) The treatment must provide meaningful therapeutic benefit over existing treatments

Question 16

Fast Track Designation

Answer 16

Designed to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases and that have the potential to address unmet medical needs. Eligible for “rolling review” allowing earlier submission and initiation of review. Can only be granted upon submission of an IND. Will respond within 60 days of reciept

Question 17

Rolling Reivew

Answer 17

FDA may consider reviewing portions of a marketing application before the complete NDA or BLA is submitted. To qualify Fast Track must have bene granted and the pivotal study must be complete or near completion

Question 18

Risk Evaluation and Mitigation Strategy

Answer 18

REMS - Allows FDA to require applicant of certain prescription drugs to submit a proposed REMS if the agency determines one is necessary to ensure that a drugs benefits outweigh it risks. Once notified sponsor must provided it within 120 days. Once FDA approves the REMS it will serve as the basis for inspection and enforcement. The drug will be considered misbranded if the applicant fails to comply with the approved REMS

Question 19

505(b)(2)

Answer 19

NDA - contains info required in a 505(b)(1) but applicant can provide some of the information required for approval in the form of studies it did not conduct and for which it has not obtained a right of reference. Added by Hatch-Waxman act to allow companies to develop alternative therapies quickly.

Question 20

505(b)(1)

Answer 20

NDA Traditional - Is a complete NDA that contains all studies conducted y the applicant necessary to demonstrate safe and effective use. Has all info per 21 CFR 314.50

Question 21

505(j)

Answer 21

Abbreviated NDA - (ANDA) - applicant is not required to include preclinical and clinical data to demonstrate safety and effectiveness. It includes chemistry and Bioequivalence data to show that the proposed product is identical in active ingredient, dosage form, strength, route of administration, labeling, quality performance characteristics and intended use of reference listed drug (RLD)

Question 22

351(a)

Answer 22

Original BLA - complete BLA contains all studies conducted by the applicant necessary to demonstrate safety and efficacy as outlined in 21 CFR 601.2

Question 23

351(k)

Answer 23

Biosimilar BLA - an abbreviated BLA for products that have been shown to be biosimilar to or “interchangeable” with an FDA licensed biological product.