FDA Launches AI Pilot to Turbocharge Early Drug Trials

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.

2026-14438 — Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements

The FDA wants your thoughts on how they collect info about infant formula rules, like labeling, quality checks, and recordkeeping. This affects infant formula makers who must follow these rules and use a new electronic form to report info. You’ve got until September 15, 2026, to share your comments—no cost changes yet, just a chance to improve how info is gathered!

2026-14441 — Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Program

The FDA wants your thoughts on a plan to improve how they check if medical products meet safety rules. This affects companies making medical devices and could change how they prove their products are safe. You’ve got until September 15, 2026, to share your ideas—no cost changes yet, just a chance to help shape the process!

2026-14436 — Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Program

The FDA wants your thoughts on a new plan to collect info from medical device makers who join a Voluntary Improvement Program. This program aims to help companies improve their devices without extra paperwork stress. If you’re involved in making or managing medical devices, you’ve got until September 15, 2026, to share your feedback—no fees, just your voice!

2026-14434 — Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Cosmetic Products

The FDA wants your thoughts on new info they might collect about cosmetic products. This affects companies making or selling cosmetics, who may need to share more details soon. You’ve got until September 15, 2026, to send in your comments—no cost yet, just your voice!

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!