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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Today (29 April 2024), FDA released a new draft guidance for the industry titled "Content and Format of Composition Statement and...

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Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released the draft guidance...

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...

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...

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...