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Sharan Murugan
Dec 92 min read
USFDA Guidance: Standardized Format for Electronic Submission of NDA and BLA Content for Bioresearch Monitoring (BIMO) Inspections
The United States Food and Drug Administration (USFDA) has released detailed guidance" Standardized Format for Electronic Submission of...
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Sharan Murugan
Sep 32 min read
USFDA Guidance: Bioresearch Monitoring Technical Conformance Guide
The USFDA Center for Drug Evaluation and Research issued the final guidance today (03 September 2024) " Bioresearch Monitoring...
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Sharan Murugan
Oct 25, 20231 min read
USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities
Earlier today (25 October,2023), the USFDA issued a draft guidance, "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch...
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