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Mar 52 min read

India CDSCO: Draft Guidance on Post Approval Changes (PAC’s) for Biologicals for consulataion

India's Central Drugs Standard Control Organization (CDSCO) has published draft guidance "Post Approval Changes in Biological Products:...

Dec 18, 20211 min read

CMC Post Approval Manufacturing Changes for Specified BLA - in Annual Reports USFDA

This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding...