Association for Accessible Medicines
FDANonrulemakingFDA-2023-D-0093

M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms; International Council for Harmonisation; Draft Guidance for Industry; Availability

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Oct 9, 2025
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closed 292d ago
Association for Accessible Medicines filings
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Association for Accessible Medicines filed 2 comments on this docket between Apr 3, 2023 and Aug 1, 2025. 0 other organizations filed here. The comment window closed 292d ago.

What Association for Accessible Medicines filed (2)

Aug 1, 2025· Comment from Association for Accessible Medicines (AAM)· FDA-2023-D-0093-0018

FDA, Please find attached comments from the Association for Accessible Medicines (AAM) regarding Docket No. FDA–2023–D–0093 "M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; Draft Guidance for Industry." Thanks, Scott Kuzner, Ph.D., Senior Director, Sciences and Regulatory Affairs, AAM

Apr 3, 2023· Comment from Association for Accessible Medicines (AAM)· FDA-2023-D-0093-0004

FDA, Please find attached comments from The Association for Accessible Medicines (AAM) regarding Docket No. FDA-2023-D-0093, "M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms; International Council for Harmonisation; Draft Guidance for Industry." Thanks, Scott Kuzner, Ph.D., Senior Director, Sciences and Regulatory Affairs Association for Accessible Medicines (AAM)

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M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms; International Council for Harmonisation; Draft Guidance for Industry; Availability (FDA) — Association for Accessible Medicines | OpenPolis