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Mar 132 min read

USFDA Guidance: Annual Reportable Labeling Changes for NDA and ANDA for Nonprescription Drug Products

Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released the draft guidance...

Dec 8, 20221 min read

USFDA Proposal: IND Annual Reports for More Comprehensive, Consistent with International Regulations

Earlier today (08-December-2022), the US Food and Drug Administration proposed a new annual reporting requirement for investigational new...

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...