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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-17498, Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661
The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice published in the Federal Register on May 27, 2026, entitled "Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661" (91 FR 31462) (the "May 2026 Notice"), as previously extended by the notice published in the Federal Register on June 26, 2026 (91 FR 38717) (the "June 2026 Notice"), by an additional 41 days. The effective date of the May 2026 Notice, which was previously extended to September 24, 2026, is hereby further extended to November 4, 2026. This further extension is necessary to allow FDA sufficient time to consider issues raised by interested parties.
2026-17401, Determination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 Milligrams/6 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 milligrams (mg)/6 milliliters (mL) (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Cabazitaxel (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), if all other legal and regulatory requirements are met.
2026-17380, International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlorphine (N-Propionitrile Chlorphine); Desalkylgidazepam (Bromonordiazepam); Ethylbromazolam; Etomethazene (5-Methyl Etodesnitazene); Spirochlorphine (R6980); Etomidate; Medetomidine; Request for Comments
The FDA is asking the public to share their thoughts on eight drugs that might get new international rules to control their use and abuse. This affects doctors, patients, and drug makers because it could change how these drugs are used medically or restricted worldwide. Comments are open until September 3, 2026, so jump in and have your say before the deadline!
Previous / Next Documents
Previous: 2026-10702, State of Indiana: NRC Staff Assessment of a Proposed Agreement Between the Nuclear Regulatory Commission and the State of Indiana
The Nuclear Regulatory Commission (NRC) is teaming up with Indiana to let the state take charge of some nuclear safety rules. This means Indiana will handle certain nuclear materials oversight, helping protect public health while keeping things running smoothly. People have until June 15, 2026, to share their thoughts before the agreement moves forward—no big costs or delays expected!
Next: 2026-10704, Extension of Lebanon Designation for Temporary Protected Status
Lebanon’s Temporary Protected Status (TPS) has been extended for six more months, from May 28 to November 27, 2026. This means Lebanese TPS holders can keep living and working in the U.S. without worry while the government reviews conditions back home. The extension happened automatically because recent events in Lebanon delayed the usual review process.