FDA Panel Debates Two Promising Cancer Drug Approvals

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.

2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use

The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.

2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use

The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.

2026-20441, Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry

The FDA is officially putting the hyperoxia monitoring device that works with pulse oximeters into a safer, easier-to-manage category called Class II. This change, effective October 6, 2026, means the device will have special safety rules but fewer regulatory hurdles, helping patients get access to this cool tech faster. Medical device makers and healthcare providers will feel the impact, with smoother approval processes and no big new costs expected.

Previous: 2026-04496, Appraisal Subcommittee Notice of Meeting

The Appraisal Subcommittee is holding a public virtual meeting on March 19, 2026, where they’ll discuss important reports and approve funding for the Appraisal Foundation. If you’re involved in property appraisals or state compliance, this meeting affects you. Make sure to register in advance to join the live webcast and stay in the loop on appraisal rules and funding updates.

Next: 2026-04498, Caribbean Fishery Management Council's Mariculture Hybrid Workshop

The Caribbean Fishery Management Council is hosting a two-day Mariculture Hybrid Workshop on March 24-25, 2026, in Puerto Rico and online. This event will bring together fishery folks, government leaders, and mariculture experts to talk about growing fish farming in the U.S. Caribbean. If you’re involved in fishing, aquaculture, or local government, this workshop could shape new rules and opportunities, possibly affecting permits and funding soon.