FDA Drops New Cheat Sheets for Generic Drug Makers
Published Date: 5/22/2026
Notice
Summary
The FDA just released new draft guides to help drug makers design studies proving their generic drugs work like the originals. If you’re in the drug business, now’s your chance to share feedback by July 21, 2026, before these guides become final. These updates aim to speed up drug approvals, potentially saving time and money for companies and patients alike!
Analyzed Economic Effects
5 provisions identified: 5 benefits, 0 costs, 0 mixed.
Draft BE Study Design Guidance
The FDA posted new draft product-specific guidances that provide product-specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). These draft guidances are available on FDA's website and are intended for industry use in planning BE studies.
Specific Drugs Listed For Guidance
FDA published lists of active ingredients for which new draft product-specific guidances (Table 1) and revised draft guidances (Table 2) are available, including drugs such as amlodipine besylate, telmisartan, carboplatin, warfarin sodium, albuterol sulfate, aripiprazole, and many others. Companies developing generic versions of the listed active ingredients can consult the corresponding draft guidances posted on FDA's website.
Public Comment Deadline Set
FDA is accepting electronic or written comments on these draft guidances and must receive comments by July 21, 2026 for consideration before FDA begins work on the final versions. Comments submitted to https://www.regulations.gov will be posted publicly unless submitted as confidential written/paper submissions following FDA instructions.
Final Guidances Reflect FDA Thinking
The notice states that when finalized, these guidances will represent FDA's current thinking on product-specific BE study design to support ANDAs, but they do not establish any rights and are not binding on FDA or the public. The notice also states you may use an alternative approach if it satisfies applicable statutes and regulations.
FDA Will Consider Cost Comments
FDA will consider comments on costs or cost savings that the guidances may generate as it develops the final guidances, noting relevance to Executive Order 14192. Stakeholders may submit cost-related comments for FDA's consideration during finalization.
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