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) - define a drug as “a product used in diagnosing, curing, mitigating, treating or preventing disease or affecting a structure or function of the body.”

Question 5

21 CFR 316

Answer 5

Orphan Drugs - affects fewer than 200K people in the US. Extends marketing exclusivity 7 years, has an accelerated approval pathway for “breakthrough therapies”. Tax credit for qualified research expenses during development.

Question 6

21 CFR 312

Answer 6

Subpart E Dugs intended to treat life-threatening and severely debilitating illnesses

Question 7

21 CFR 314

Answer 7

Subpart H 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

Question 17

21 CFR 207

Answer 17

Registration of Producers of Drugs and Listing of Drugs in Commercial Distrubution

Question 18

21 CFR 190.6

Answer 18

Requirement for premarket notification (dietary supplements)

Question 19

21 CFR 3.2(e)

Answer 19

Assignment of agency component for review of premarket applications - definitions

Question 20

21 CFR 328-358

Answer 20

OTC Monographs

Question 21

21 CFR 330.11

Answer 21

NDA deviations from applicable monograph (OTC drugs)

Question 22

21 CFR 10.30

Answer 22

Citizen petiton

Question 23

21 CFR 862-892

Answer 23

Device Classifications

Question 24

21 CFR 807

Answer 24

Subpart E Premarket notification procedures

Question 25

21 CFR 812

Answer 25

Investigational Device Exemptions

Question 26

21 CFR 814

Answer 26

Subpart H Humanitarian use devices

Question 27

21 CFR 56

Answer 27

Institutional Review Boards

Question 28

21 CFR 50

Answer 28

Protection of Human Subject

Question 29

21 CFR 54

Answer 29

Financial Disclosure by Clinical Invetigators

Question 30

21 CFR 814

Answer 30

Premarket Approval of Medical Devices

Question 31

21 CFR 807

Answer 31

Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

Question 32

Abbreviated New Drug Application

Answer 32

ANDA - After the patent of the innovator drug expired abbreviated applications could be submitted for generic dugs. Not required to submit animal safety and clinical data to establish safety and effectiness

Question 33

Generic Drug

Answer 33

Is comparable to the innovator dug product in dosage form strength, route of administration, quality, performance characteristics and intended use.

Question 34

ANDA Contains

Answer 34

- Chemistry, manufacturing and controls (CMC) information - Bioequivalence data - Administrative information (including labeling and patent certification information

Question 35

RFD

Answer 35

Request for Designation