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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Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released the draft guidance...
Sharan Murugan
Mar 13, 20242 min read
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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...
Sharan Murugan
Dec 8, 20221 min read
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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...
Sharan Murugan
Dec 18, 20211 min read
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