Drug, Biologic and Device Regulatory Pathway

Question 0

21 CFR 314.92

Answer 0

Drug products for which abbreviated applications may b submitted

Question 1

Food and Drug Administration Safety and Innovation Act (Jan 2012)

Answer 1

a

Question 2

21 CFR 314.93

Answer 2

Petition to request a change from a listed drug

Question 3

21 CFR 314.54

Answer 3

Procedure for submission of an application requiring investigations for approval of a new indication for, or other change form, a listed drug

Question 4

12 CFR 310.3

Answer 4

Definitions and interpretations (new drugs)

Question 5

21 CFR 316

Answer 5

Orphan Drugs

Question 6

21 CFR 312 Subpart E

Answer 6

Dugs intended to treat life-threatening and severely debilitating illnesses

Question 7

21 CFR 314 Subpart H

Answer 7

Accelerated approval of new drugs for serious or life-threatening illnesses

Question 8

21 CFR 312

Answer 8

Investigational New Drug Application

Question 9

21 CFR 312.50

Answer 9

General responsibilities of sponsors

Question 10

21 CFR 312.60

Answer 10

General responsibilities for investigators

Question 11

21 CFR 312.33

Answer 11

Annual reports (IND)

Question 12

21 CFR 312.32

Answer 12

IND safety reports

Question 13

21 CFR 312.23

Answer 13

IND content and format

Question 14

21 CFR 312.38

Answer 14

Withdrawal of an IND

Question 15

21 CFR 312.45

Answer 15

Inactive status (IND)

Question 16

21 CFR 314

Answer 16

Applications for FDA Approval to Market a New Drug