FDA to Swap 'Gender' for 'Sex' in Regs, Defending Women from Ideology

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.

2026-15635, 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.

2026-15613, 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.

2026-15612, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs." This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The revised draft guidance is intended to clarify FDA's recommendations and expectations related to in vivo skin irritation and in vivo combined skin irritation and sensitization studies. This draft guidance replaces the draft guidance "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs" (April 2023).

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.

Previous: 2026-15670, Roof Control Plan Approval Criteria

In response to a public request, the Mine Safety and Health Administration (MSHA) is reopening the rulemaking record and is scheduling a virtual public hearing on the Agency's proposed rule published on July 1, 2025, titled, "Roof Control Plan Approval Criteria."

Next: 2026-15677, Petition for Reconsideration of Action in Rulemaking Proceeding

Petitions for Reconsideration (Petitions) have been filed in the Commission's proceeding by Chris Webber on behalf of CRW Consulting LLC and Kristen Corra on behalf of Schools, Health & Libraries Broadband Coalition.