Asia Regulatory Roundup: CFDA Posts Draft Guidance on Postapproval Manufacturing Changes (24 October 2017)
By Nick Paul Taylor -
Published 24 October 2017
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Categories: News, Asia, CDSCO, CFDA, Drugs, Government affairs
Tags: postapproval manufacturing changes, Sun Pharma
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manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report.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Tags: BLA, CMC changes, postapproval manufacturing changes, FDA draft guidance