New FDA Rules Clarify Generic Drug Equivalence Tests
Published Date: 5/29/2026
Notice
Summary
The FDA just released final guidance to help drug companies prove their generic drugs work just like the original ones by using bioequivalence studies. This affects anyone submitting or updating abbreviated new drug applications (ANDAs) and aims to make the approval process clearer and smoother. Companies should review these new rules now to avoid delays and extra costs when getting their generics to market.
Analyzed Economic Effects
5 provisions identified: 5 benefits, 0 costs, 0 mixed.
Final BE Guidance for ANDA Applicants
The FDA issued final guidance titled "Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA" on May 29, 2026. The guidance gives recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements and is intended to make the approval process clearer and smoother so companies should review it now to avoid delays and extra costs when getting generics to market.
Key Updates from Draft to Final
The final guidance includes updates to align recommendations with the M13A guidance issued October 31, 2024, clarifications about study population and study design, updates to in vitro dissolution testing information, and removal of certain statistical-analysis appendices (those appendices were incorporated into the concurrently issued guidance "Statistical Approaches to Establishing Bioequivalence").
Which Products the Guidance Covers
The guidance applies to immediate-release and modified-release oral dosage forms and to non-oral drug products where systemic exposure measures can establish bioequivalence, for example transdermal delivery systems and certain rectal and nasal drug products. It also applies when applicants plan BE studies during the postapproval period for changes to a drug product approved under an ANDA.
Guidance Is Non-Binding; Alternatives Allowed
The guidance represents FDA's current thinking but does not establish any rights and is not binding on FDA or the public; applicants may use an alternative approach if it satisfies applicable statutes and regulations. FDA finalized this guidance consistent with its good guidance practices (21 CFR 10.115).
No New Information Collection Burden
The guidance itself contains no new collection of information. It refers to previously approved information collections under several OMB control numbers (for example, OMB control numbers 0910-0130, 0910-0572, 0910-0014, 0910-0291, 0910-0001, 0910-0191, 0910-0727, and 0910-0119) that remain subject to the Paperwork Reduction Act of 1995 review.
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Key Dates
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