Postapproval Changes to Drug Substances Guidance for Industry

Issue Date: September 11, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC)
Status: Draft

Postapproval Changes to Drug Substances Guidance for Industry

This guidance provides recommendations to holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs) and holders of drug master files (DMFs) and veterinary master files (VMFs) who want to make a change to the drug substance manufacturing process during the drug product application’s postapproval period. It does not address holders of biologics license applications (BLAs) or holders of any master files cross-referenced in BLAs.

Download the Guidance Document

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