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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
Oct 23, 20232 min read
USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products
A final guidance "Benefit-Risk Assessment for New Drug and Biological Products" was published last week (17 October, 2023) by the US Food...
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Sharan Murugan
Oct 17, 20221 min read
USFDA Guidance: Comparability Protocols for Postapproval Changes to CMC in an NDA, ANDA, or BLA
This guidance was finalized and released by the Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and...
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Sharan Murugan
Oct 6, 20221 min read
USFDA Guidance: Four Finalized User Fees and Refunds related Medical Devices Guidelines
USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research finalized and released four Medical...
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Sharan Murugan
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...
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Sharan Murugan
Jun 27, 20211 min read
Guidance on CMC Changes to an Approved Application- US-FDA
FDA issued final guidance on June 21, 2021 to aid applicants of certain licensed biological products to determine the appropriate...
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