Notice
9 Sep 2025
fda, bioequivalence, pharmaceutical, draft guidance, regulation
💊FDA Reopens Comment Period on Bioequivalence Guidance for Industry
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the draft guidance announced in the notice entitled "M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; Draft Guidance for Industry," published in the Federal Register of June 2, 2025. The Agency is taking this action to allow interested persons additional time to submit comments.
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