FDA's Latest Yawn: More Generic Drug Study Guidelines Drop
Published Date: 7/29/2026
Notice
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 0 costs, 1 mixed.
Draft BE Study Guidance Posted
FDA posted revised draft product-specific guidances that give recommendations on how to design bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for these active ingredients: Calcitonin salmon; Dasiglucagon hydrochloride; Glucagon; Liraglutide; Pegcetacoplan; Semaglutide; Teriparatide; Tirzepatide; and Vosoritide. Submit comments by September 28, 2026 if you want FDA to consider them before the Agency begins work on final versions.
May 2021 Peptide ANDA Guidance Withdrawn
FDA is withdrawing the May 2021 guidance titled "ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin" because it no longer reflects the Agency's current scientific thinking. FDA plans to revise and reissue that guidance in 2026.
Draft Guidances Are Non‑Binding
FDA states these draft guidances do not establish any rights and are not binding on FDA or the public. You may use an alternative approach for BE study design if it satisfies the requirements of the applicable statutes and regulations.
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