Post Approval Prescription Drug Submissions and Compliance

Question 0

21 CFR 201.122

Answer 0

Exemptions from Adequate Directions for Use - Drugs for processing repacking, or manufacturing

Question 1

21 CFR 7.40-7.59

Answer 1

Recalls (Including Product Corrections) - Guidance on Policy, Procedures, and Industry Responsibilities

Question 2

21 CFR 207

Answer 2

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

Question 3

21 CFR 210

Answer 3

Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

Question 4

21 CFR 211

Answer 4

Current Good Manufacturing Practice for Finished Pharmaceuticals

Question 5

21 CFR 312.32

Answer 5

IND Safety Reports

Question 6

21 CFR 312.110

Answer 6

Import and export requirements

Question 7

21 CFR 314.70

Answer 7

Supplements and other changes to an approved application

Question 8

21 CFR 314.71

Answer 8

Procedures for submission of a supplement to an approved application

Question 9

21 CFR 314.72

Answer 9

Change in ownership f an application

Question 10

21 CFR 314.80

Answer 10

Postmarketing reporting of adverse drug experiences

Question 11

21 CFR 314.81

Answer 11

Other postmarketing reports

Question 12

21 CFR 314.410

Answer 12

Imports and exports of new drugs

Question 13

21 CFR 314.420

Answer 13

Drug Master File

Question 14

21 CFR 314.550

Answer 14

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

Question 15

Annual Reports

Answer 15

Are level 1 changes or minor change. These types of changes include: site changes within a single facility and process changes within validated ranges.

Question 16

CBE-0 or CBE-30

Answer 16

Level 2 changes or moderate changes. These include: composition changes and changes in manufacturing equipment.

Question 17

Prior Approval Supplement (PSA)

Answer 17

Level 3 changes or major changes. These include: Site changes to the use of a new manufacturer that does not have experience with the product type.

Question 18

Class I Recall

Answer 18

When there is a reasonable probability that the use of r exposure to a suspected product will cause serious adverse health consequences or death

Question 19

Class II Recall

Answer 19

When the use of or exposure to a suspected product may cause temporary or medically reversible adverse health consequences, or where the probability of serous adverse health consequence is remote

Question 20

Class III Recall

Answer 20

When se of or exposure to a suspected product is not likely to cause adverse health consequences, but the product violates FDA labeling or manufacturing laws.

Question 21

Market Withdrawl

Answer 21

When a product has a minor violation that would not be subject to FDA legal action and the firm removes the product from the market or corrects the violation

Question 22

Medical Device Safety Alert

Answer 22

Is issued in situations where a medical device may present an unreasonable risk of substantial harm

Question 23

Drug Master File

Answer 23

DMF - is a voluntary submission intended to protect the confidentiality of the information submitted. There are 4 types:II, III, IV or V. Can be submitted in hard copy or digitally in either Common Technical Document (CTD) or traditional format. Can be used to support: IND, NDA or ANDA, an amendment or supplement to these or another DMF. Not approved by FDA only reviewed.

Question 24

Type II DMF

Answer 24

chemistry, manufacture and control information for drug substances, intermediates and materials used in their preparation or similar information for drug products. A fee is required for this type per GDUFA (Generic Drug User Fee Act). The fee is paid only once during the life of the DMF

Question 25

Type III DMF

Answer 25

Component, composition, controls for release and intended uses of packaging materials

Question 26

Type IV DMF

Answer 26

Excipients, colorants, flavors, essences or materials used in their preparation

Question 27

Type V DMF

Answer 27

FDA-accepted reference information