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# Expand Draft Guidance on BE Studies in ANDAs: AAM
- URL: https://www.fdaweb.com/expand-draft-guidance-on-be-studies-in-andas-aam/
- Published: 2021-10-26T12:00:00.000Z
- Updated: 2026-09-14T17:20:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150441

The Association for Accessible Medicines (AAM) says FDA should expand the scope of the draft guidance *Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA* to include complex formulations like inhalation products, liposomal products, and vaginal cream. “Additional clarity around FDA’s expectations related to locally acting oral products would also be helpful,” the generic drug trade group says in a comment [letter](https://downloads.regulations.gov/FDA-2013-D-1464-0019/attachment%5F1.pdf?ref=fdaweb.com).

AAM also submits line-by-line specific comments.