Description
This document provides questions and answers relating to the guidance on Changes to an Approved NDA or ANDA (the guidance).2 The questions are based on those posed to CDER by applicants. The questions and answers are presented using subject headings that correspond to the table of contents in the guidance
Scope & Applicability
Product Classes
4Product type discussed regarding scale-up changes.
Example of risk assessment for manufacturing process
Specific product category with different scale-up reporting recommendations.
Elements exposed to aseptic conditions making up the sterile finished drug product
Stakeholders
3Entity submitting development data and knowledge; Entity performing the work process for change
Contract acceptor for transportation of APIs
A facility that packages food for a fee.
Regulatory Context
Attributes
7assuring and preserving the identity of the new animal drug
CMC changes after tentative approval; shelf-life period supported by stability data; proposing to extend the expiration dating period for the drug product
controls in place to maintain the strength, composition, and purity
assuring and preserving the quality of the new animal drug
specifications for the purity, strength, and composition of dietary supplements
Measurement of potency for biological products
Status of a facility's compliance with quality standards
Related CFR Sections (1)
- 21CFR211.194§ 211.194 Laboratory records.
(a) Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows:Read full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Darmerica, LLC
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Medinatura New Mexico, Inc.
- 2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
CDL Services, Inc. DBA Technichem
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
Seaway Pharma Inc.
See Also (8)
- Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages: Guidance for Industry (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)
- Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-The-Counter Human Use — Small Entity Compliance Guide: Guidance for Industry (Status: Final)
- Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (Status: Final)
- Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 : Guidance for Industry (Status: Final)
- For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for Industry (Status: Final)
- Cooperative Manufacturing Arrangements for Licensed Biologics: Guidance for Industry (Status: Final)
- Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (Status: Final)