ACPS November 15, 2000. 314.70 Update Nancy B. Sager, Associate Director Office of Pharmaceutical Science Center for Drug Evaluation & Research Food and Drug Administration. Regulatory Approach. CDER’s regulatory approach to post approval CMC changes is evolving
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ACPSNovember 15, 2000
Nancy B. Sager, Associate Director
Office of Pharmaceutical Science
Center for Drug Evaluation & Research
Food and Drug Administration
CDER’s regulatory approach to post approval CMC changes is evolving
Scale Up/Post Approval Change - Guidance Documents
Reporting categories are based on the potential for the change to adversely affect the identity, strength, quality, purity, or potency of a product as they may relate to the safety or effectiveness of the drug product.
(30 comment letters, 1200 individual comments)
(30 comment letters, 300 individual comments)
The November 1999 guidance on Changes to an Approved NDA or ANDA represents FDA’s current thinking on how it will apply the requirements of section 506A of the Act for NDA and ANDA products.
Until the final regulation for § 314.70 publishes, section 506A is the sole basis for FDA’s regulation of postapproval manufacturing changes for products approved in NDAs or ANDAs