FDA's Upcoming Product-Specific Guidances for Generic Drug Development

1. Overview

The FDA outlines plans under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to publish new and revised product-specific guidances (PSGs) quarterly or as needed. These PSGs support the development of safe and effective generic products by detailing the FDA's expectations for bioequivalence (BE) studies and other evidence needed to aid in the approval of Abbreviated New Drug Applications (ANDAs) for both complex and non-complex drugs. Source: https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-generic-drug-product-development

2. Purpose of PSGs

PSGs provide recommendations on the design of studies necessary to demonstrate that a generic drug is therapeutically equivalent to its reference listed drug. They are particularly useful for complex products, which include those with complex active ingredients (e.g., peptides, naturally sourced), formulations (e.g., liposomes), routes of delivery (e.g., ophthalmic suspensions), dosage forms (e.g., transdermals, inhalers), drug-device combinations, or other complexities that may benefit from early scientific engagement. Source: https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-generic-drug-product-development

3. Planned New PSGs

The page lists planned new PSGs for the next 12 months, subject to change. The table, updated January 13, 2026, includes details such as active ingredient, route, dosage form, RLD/RS number, complexity (complex or non-complex), planned publication month (e.g., 02/2026), and updates (e.g., 'Newly added'). Examples include:

• Non-complex: Aceclidine HCl (Ophthalmic; Solution/Drops; 218585; 02/2026)
• Complex: Amikacin Sulfate (Inhalation; Suspension, Liposomal; 207356; Beyond 12 months) Publications range from February 2026 to November 2026, with some listed as 'Within next 12 months' or 'Beyond 12 months'. Source: https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-generic-drug-product-development

4. Planned Revised PSGs

Revised PSGs are categorized by the impact of the revision:

• Critical Revision: Adds new BE studies/evidence necessary for approval due to changes affecting safety or effectiveness; affects all ANDAs.
• Major Revision: Adds new BE studies/evidence; subtypes include in vivo (additional in vivo studies) or in vitro (additional in vitro studies). Applicants may request PSG teleconferences under GDUFA III.
• Minor Revision: Changes that do not require additional studies, such as adding BE options or clarifying designs.
• Editorial Revision: Non-substantive updates like formatting or references. The table, updated December 8, 2025, lists active ingredients, routes, dosage forms, RLD/RS numbers, revision categories/descriptions, complexity, planned publication, and updates. Examples include:
• Non-complex: Acetaminophen; Ibuprofen (Oral; Tablet; 211733; Minor Revision: Add in vivo BE option; 02/2026)
• Complex: Albuterol Sulfate (Inhalation; Aerosol, Metered; 020503 etc.; Minor Revision: Clarify in vitro BE study design; 02/2026) Revisions often involve adding BE options, clarifying study designs, updating strengths, or aligning with international standards like ICH M13A. Source: https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-generic-drug-product-development

5. Updates and Disclaimers

The lists are updated quarterly, removing published PSGs and adding new ones to aid in planning generic drug development. The information is for planning purposes and subject to change based on various factors. Source: https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-generic-drug-product-development