FDA Guides Industry on Skin Irritation Tests for Drug Patches and Creams

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.

2026-15636, Ricardo Andres Acuna: Final Debarment Order

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Ricardo Andres Acuna from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ricardo Andres Acuna was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Mr. Acuna was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of May 6, 2026 (30 days after receipt of the notice), Mr. Acuna has not responded. Mr. Acuna's failure to respond and request a hearing constitutes a waiver of Mr. Acuna's right to a hearing concerning this matter.

2026-15613, Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs." This guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only, or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The guidance replaces the draft guidance (Revision 2) "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs," issued on April 13, 2023.

2026-15635, Angela Anatilde Baquero: Final Debarment Order

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Angela Anatilde Baquero from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Angela Anatilde Baquero was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Mrs. Baquero was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of May 6, 2026 (30 days after receipt of the notice), Mrs. Baquero has not responded. Mrs. Baquero's failure to respond and request a hearing constitutes a waiver of Mrs. Baquero's right to a hearing concerning this matter.

2026-15335, Medical Device User Fee Rates for Fiscal Year 2027

Starting October 1, 2026, medical device companies will see updated user fees for submitting their products to the FDA and for annual registrations. These fees help the FDA review and monitor medical devices, with special discounts available for small businesses. If you’re in the medical device world, get ready to budget for these new costs through September 30, 2027!

Previous: 2026-15611, Agency Information Collection Activities

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the U.S. Election Assistance Commission (EAC) gives notice that it is requesting from the Office of Management and Budget (OMB) an extension of the previously approved information collection OMB Control Number 3265-0026 EAC Progress Report (EAC-PR).

Next: 2026-15613, Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs." This guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only, or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The guidance replaces the draft guidance (Revision 2) "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs," issued on April 13, 2023.