Drug, Biologic and Device Regulatory Pathway Flashcards

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0
Q

21 CFR 314.92

A

Drug products for which abbreviated applications may b submitted

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1
Q

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

A

a

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2
Q

21 CFR 314.93

A

Petition to request a change from a listed drug

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3
Q

21 CFR 314.54

A

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

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4
Q

12 CFR 310.3

A

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.”

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5
Q

21 CFR 316

A

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.

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6
Q

21 CFR 312

A

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

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7
Q

21 CFR 314

A

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

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8
Q

21 CFR 312

A

Investigational New Drug Application

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9
Q

21 CFR 312.50

A

General responsibilities of sponsors

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10
Q

21 CFR 312.60

A

General responsibilities for investigators

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11
Q

21 CFR 312.33

A

Annual reports (IND)

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12
Q

21 CFR 312.32

A

IND safety reports

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13
Q

21 CFR 312.23

A

IND content and format

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14
Q

21 CFR 312.38

A

Withdrawal of an IND

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15
Q

21 CFR 312.45

A

Inactive status (IND)

16
Q

21 CFR 314

A

Applications for FDA Approval to Market a New Drug

17
Q

21 CFR 207

A

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

18
Q

21 CFR 190.6

A

Requirement for premarket notification (dietary supplements)

19
Q

21 CFR 3.2(e)

A

Assignment of agency component for review of premarket applications - definitions

20
Q

21 CFR 328-358

A

OTC Monographs

21
Q

21 CFR 330.11

A

NDA deviations from applicable monograph (OTC drugs)

22
Q

21 CFR 10.30

A

Citizen petiton

23
Q

21 CFR 862-892

A

Device Classifications

24
Q

21 CFR 807

A

Subpart E Premarket notification procedures

25
Q

21 CFR 812

A

Investigational Device Exemptions

26
Q

21 CFR 814

A

Subpart H Humanitarian use devices

27
Q

21 CFR 56

A

Institutional Review Boards

28
Q

21 CFR 50

A

Protection of Human Subject

29
Q

21 CFR 54

A

Financial Disclosure by Clinical Invetigators

30
Q

21 CFR 814

A

Premarket Approval of Medical Devices

31
Q

21 CFR 807

A

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

32
Q

Abbreviated New Drug Application

A

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

33
Q

Generic Drug

A

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

34
Q

ANDA Contains

A
  • Chemistry, manufacturing and controls (CMC) information
  • Bioequivalence data
  • Administrative information (including labeling and patent certification information
35
Q

RFD

A

Request for Designation