FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics
By Zachary Brennan -
Published 08 August 2017
As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report.
Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Postmarket surveillance
Tags: BLA, CMC changes, postapproval manufacturing changes, FDA draft guidance