Drug, Biologic and Device Regulatory Pathway Flashcards
21 CFR 314.92
Drug products for which abbreviated applications may b submitted
Food and Drug Administration Safety and Innovation Act (Jan 2012)
a
21 CFR 314.93
Petition to request a change from a listed drug
21 CFR 314.54
Procedure for submission of an application requiring investigations for approval of a new indication for, or other change form, a listed drug
12 CFR 310.3
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.”
21 CFR 316
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.
21 CFR 312
Subpart E Dugs intended to treat life-threatening and severely debilitating illnesses
21 CFR 314
Subpart H Accelerated approval of new drugs for serious or life-threatening illnesses
21 CFR 312
Investigational New Drug Application
21 CFR 312.50
General responsibilities of sponsors
21 CFR 312.60
General responsibilities for investigators
21 CFR 312.33
Annual reports (IND)
21 CFR 312.32
IND safety reports
21 CFR 312.23
IND content and format
21 CFR 312.38
Withdrawal of an IND
21 CFR 312.45
Inactive status (IND)
21 CFR 314
Applications for FDA Approval to Market a New Drug
21 CFR 207
Registration of Producers of Drugs and Listing of Drugs in Commercial Distrubution
21 CFR 190.6
Requirement for premarket notification (dietary supplements)
21 CFR 3.2(e)
Assignment of agency component for review of premarket applications - definitions
21 CFR 328-358
OTC Monographs
21 CFR 330.11
NDA deviations from applicable monograph (OTC drugs)
21 CFR 10.30
Citizen petiton
21 CFR 862-892
Device Classifications
21 CFR 807
Subpart E Premarket notification procedures
21 CFR 812
Investigational Device Exemptions
21 CFR 814
Subpart H Humanitarian use devices
21 CFR 56
Institutional Review Boards
21 CFR 50
Protection of Human Subject
21 CFR 54
Financial Disclosure by Clinical Invetigators
21 CFR 814
Premarket Approval of Medical Devices
21 CFR 807
Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
Abbreviated New Drug Application
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
Generic Drug
Is comparable to the innovator dug product in dosage form strength, route of administration, quality, performance characteristics and intended use.
ANDA Contains
- Chemistry, manufacturing and controls (CMC) information
- Bioequivalence data
- Administrative information (including labeling and patent certification information
RFD
Request for Designation
