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
Annual Reports
Are level 1 changes or minor change. These types of changes include: site changes within a single facility and process changes within validated ranges.
CBE-0 or CBE-30
Level 2 changes or moderate changes. These include: composition changes and changes in manufacturing equipment.
Prior Approval Supplement (PSA)
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.
Class I Recall
When there is a reasonable probability that the use of r exposure to a suspected product will cause serious adverse health consequences or death
Class II Recall
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
Class III Recall
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.
Market Withdrawl
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
Medical Device Safety Alert
Is issued in situations where a medical device may present an unreasonable risk of substantial harm
Drug Master File
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.
Type II DMF
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
Type III DMF
Component, composition, controls for release and intended uses of packaging materials
Type IV DMF
Excipients, colorants, flavors, essences or materials used in their preparation
Type V DMF
FDA-accepted reference information
