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Sharan Murugan
- Oct 23, 2023
- 2 min
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, 2022
- 1 min
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, 2022
- 1 min
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, 2021
- 1 min
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, 2021
- 1 min
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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