Post Approval Prescription Drug Submissions and Compliance Flashcards

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0
Q

21 CFR 201.122

A

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

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1
Q

21 CFR 7.40-7.59

A

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

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2
Q

21 CFR 207

A

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

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3
Q

21 CFR 210

A

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

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4
Q

21 CFR 211

A

Current Good Manufacturing Practice for Finished Pharmaceuticals

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5
Q

21 CFR 312.32

A

IND Safety Reports

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6
Q

21 CFR 312.110

A

Import and export requirements

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7
Q

21 CFR 314.70

A

Supplements and other changes to an approved application

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8
Q

21 CFR 314.71

A

Procedures for submission of a supplement to an approved application

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9
Q

21 CFR 314.72

A

Change in ownership f an application

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10
Q

21 CFR 314.80

A

Postmarketing reporting of adverse drug experiences

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11
Q

21 CFR 314.81

A

Other postmarketing reports

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12
Q

21 CFR 314.410

A

Imports and exports of new drugs

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13
Q

21 CFR 314.420

A

Drug Master File

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14
Q

21 CFR 314.550

A

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

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15
Q

Annual Reports

A

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

16
Q

CBE-0 or CBE-30

A

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

17
Q

Prior Approval Supplement (PSA)

A

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.

18
Q

Class I Recall

A

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

19
Q

Class II Recall

A

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

20
Q

Class III Recall

A

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.

21
Q

Market Withdrawl

A

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

22
Q

Medical Device Safety Alert

A

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

23
Q

Drug Master File

A

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.

24
Q

Type II DMF

A

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

25
Q

Type III DMF

A

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

26
Q

Type IV DMF

A

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

27
Q

Type V DMF

A

FDA-accepted reference information