💊FDA Reopens Comment Period on Bioequivalence Guidance for Industry
M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; Draft Guidance for Industry; Reopening of the Comment Period
Summary
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the draft guidance announced in the notice entitled "M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; Draft Guidance for Industry," published in the Federal Register of June 2, 2025.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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The content involves reopening the comment period for draft guidance on bioequivalence for immediate-release solid oral dosage forms, impacting compliance and regulatory requirements for pharmaceutical businesses. Business owners may need to adapt submissions or processes to align with the new guidelines and participate in shaping industry standards.