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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
Apr 272 min read
USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling
Today (29 April 2024), FDA released a new draft guidance for the industry titled "Content and Format of Composition Statement and...
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Sharan Murugan
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Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released the draft guidance...
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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
Apr 17, 20222 min read
FDA's Bioavailability Guidance for NDAs or INDs- General consideration
The US Food and Drug Administration (FDA) has published a final guidance regarding bioavailability data that drug sponsors should include...
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