TRUQAP's Patent Gets FDA Lifeline: More Pharma Paperwork

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.

2026-16714, Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food

The Food and Drug Administration (FDA or the 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 provisions of FDA's third-party disclosure and recordkeeping requirements for reportable food.

2026-16712, Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries

The FDA wants your thoughts on how they collect info about imports and electronic import entries. If you’re involved in importing goods, this could affect you! They’re asking for comments by October 16, 2026, to help improve the process without adding extra costs or hassle.

2026-16715, Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Previous: 2025-11319, Determination of Regulatory Review Period for Purposes of Patent Extension; EXEM FOAM

The FDA has officially set the review period for EXEM FOAM, a human drug product, so its patent can be extended. This means the company behind EXEM FOAM gets more time to protect their invention and keep competitors at bay. If you’re in the drug business, watch the clock—this extension affects when generics can enter the market and could impact money flows.

Next: 2025-11321, Determination of Regulatory Review Period for Purposes of Patent Extension; COLUMVI

The FDA has officially set the review period for COLUMVI, a human biological product, so its patent can be extended. This helps the company behind COLUMVI get extra time to protect their invention before generic versions can appear. If you’re involved in drug patents or healthcare, this timing update matters for future market competition and innovation.