Description
To describe the information requested by the Center for Drug Evaluation and Research (CDER) in an Annual Report to a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Abbreviated Antibiotic Application (AADA) submitted pursuant to 21 CFR 314.81(b)(2).
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2General category for tablets and capsules discussed in the coating and drilling sections.
drug product expiration dating period
Stakeholders
1entity submitting marketing applications
Regulatory Context
Regulatory Activities
4Recommendations for pharmaceutical sponsors of abbreviated antibiotic drug applications.
Abbreviated New Drug Application
New Drug Application
Reporting category for minor changes; Submission type for low-risk drug product documentation; inclusion of specification changes in an annual report
Document Types
4Protocol design for formal stability studies; Incorporates information to establish re-test period or shelf life; Design and execution of a stability protocol to support formal studies; Design for supporting drug substance or drug product shelf life; Design of the stability study including frequency and conditions; Written protocol for holding time studies; Design of in-use stability study protocols; Reduced Stability Protocol Design discussed in Annex 1; Including intermediate storage condition
A submission to FDA that may be used to provide confidential information about facilities or processes.; cross-referencing a DMF in a BLA
Reporting category for minor changes like removing a color additive
Document where unexpected behaviors might be listed as possible.
Attributes
1drug product expiration dating period
Technical Details
Substances
1Active ingredient in the CGT product
Testing Methods
2High-Performance Liquid Chromatography used for impurities or assay.
validation of methods unless in pharmacopoeia
Standards & References
External Standards
1Changes made to comply with changes in an official compendium.
Specifications
3Assessment of manufacturing processes related to shell release specifications.
Standards for testing container and closure systems
Regulatory specifications for the drug substance and drug product should be listed.
Related CFR Sections (2)
- 21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- CPG Sec 120.500 Health Fraud - Factors in Considering Regulatory Action (Status: Final)
- Evaluating the Risks of Drug Exposure in Human Pregnancies (Status: Final)
- How to Comply with the Pediatric Research Equity Act (Status: Draft)
- Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (Status: Final)
- Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (Status: Final)
- Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets (Status: Final)
- Benefit-Risk Considerations for Product Quality Assessments (Status: Draft)
- Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act (Status: Draft)