Navigating the FDA's Guidelines for Variations in Pharmaceuticals
- Jeremy Jakob
- Dec 1, 2023
- 1 min read
This post contains a list of links giving access to the most relevant variation guidance published by FDA.
Guidance "Changes to an approved NDA or ANDA"
Guidance "Changes to an Approved NDA or ANDA: Questions and Answers"
Guidance "CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports"
Draft Guidance "CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports" Link
Guidance "Postapproval Changes to Drug Substances"
Guidance "Variations in Drug Products that May Be Included in a Single ANDA"
Guidance "PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites"
Guidance "Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products" (link)
Guidance "Changes to an Approved Application: Biological Products" Link
