Post Approval Prescription Drug Submissions and Compliance Flashcards
21 CFR 201.122
Exemptions from Adequate Directions for Use - Drugs for processing repacking, or manufacturing
21 CFR 7.40-7.59
Recalls (Including Product Corrections) - Guidance on Policy, Procedures, and Industry Responsibilities
21 CFR 207
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
21 CFR 210
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
21 CFR 211
Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR 312.32
IND Safety Reports
21 CFR 312.110
Import and export requirements
21 CFR 314.70
Supplements and other changes to an approved application
21 CFR 314.71
Procedures for submission of a supplement to an approved application
21 CFR 314.72
Change in ownership f an application
21 CFR 314.80
Postmarketing reporting of adverse drug experiences
21 CFR 314.81
Other postmarketing reports
21 CFR 314.410
Imports and exports of new drugs
21 CFR 314.420
Drug Master File
21 CFR 314.550
Accelerated approval of new drugs for serious or life-threatening illnesses - promotional materials