FDA Launches AI Pilot to Turbocharge Early Drug Trials

2026-16296, Substances Generally Recognized as Safe

The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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.

2026-17659, Rahim Shafa; Denial of Hearing; Final Debarment Order

The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Rahim Shafa (Dr. Shafa) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Dr. Shafa from providing services in any capacity to a person that has an approved or pending drug product application and debarring Dr. Shafa for 20 years from importing or offering for import any drug into the United States. FDA bases this order on the findings that Dr. Shafa was convicted of multiple felonies under Federal law that relate to the regulation of any drug product under the FD&C Act and the importation into the United States of any drug or controlled substance under the FD&C Act. FDA provided notice to Dr. Shafa of the proposed debarment and an opportunity to request a hearing. Dr. Shafa submitted a request for a hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.

2026-17676, Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees.

2026-17598, Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the generic collection of focus group information as used by FDA for all FDA-regulated products.

Previous: 2026-10601, Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension: Rule 17a-22

The SEC is asking to keep a rule that makes clearing agencies share important updates on their websites within two days. This helps the SEC keep an eye on changes and make sure everything’s fair and clear. Seven active clearing agencies spend about 15 minutes per update, totaling around 210 hours a year, with no new costs or big changes planned.

Next: 2026-10603, Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments

The FDA is hosting a virtual meeting on June 15, 2026, to talk about how to better track food by its lot number, making food safer and easier to trace. This affects food producers, sellers, and anyone involved in food safety, with a chance to suggest flexible ways to follow the rules. Comments on the ideas are open until July 15, 2026, so get involved and help shape the future of food tracking!