FDA Tweaks Patent Delay Petitions for Drugs
Published Date: 5/21/2026
Notice
Summary
The FDA is updating how companies ask for extra patent time when their new drugs or devices take a while to get approved. This affects drug and medical device makers who want to protect their inventions longer. Comments on these changes are open until June 22, 2026, and the update aims to keep the process clear without adding extra costs or delays.
Analyzed Economic Effects
3 provisions identified: 0 benefits, 3 costs, 0 mixed.
Estimated Annual Time Burden
FDA estimates annual respondent burden of 560 hours total: five revision requests of regulatory review period determinations at 100 hours each (500 hours), one due diligence petition at 50 hours, and one due diligence hearing request at 10 hours. FDA estimates no capital or operating costs and based these numbers on the average filings over the past 3 years.
Paperwork Rules for Patent Extensions
If you are a patent holder for a new drug, biologic, medical device, animal drug, food additive, or color additive, FDA is continuing the information-collection requirements (OMB control number 0910-0233) for petitions under 21 CFR part 60. The agency submitted this paperwork collection to OMB for review under the Paperwork Reduction Act and is seeking public comment by June 22, 2026.
No Change to 'Due Diligence' Definition
FDA stated it believes the existing definition of "due diligence" in 21 CFR 60.36(a) is adequate and will not revise that definition in this submission. Petitioners should plan under the current definition, which FDA quotes as the degree of attention, continuous directed effort, and timeliness reasonably expected during a regulatory review period.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
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 / Next Documents
Previous: 2026-10189, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs
The FDA is asking for approval to keep collecting info about problems with approved new animal drugs, like side effects or manufacturing issues. This helps make sure animal medicines stay safe and effective. Drug companies need to keep reporting these issues, and the public can comment until June 22, 2026. There’s no new cost, just a continuation of current rules.
Next: 2026-10191, Agency Information Collection Activities; Proposed Information Collection Request; Comment Request; Performance Evaluation Studies on Wastewater Laboratories (Renewal)
The EPA wants to keep checking how well wastewater labs do their tests by renewing a paperwork request that helps them gather info. This affects labs that test water and anyone interested can share their thoughts by July 20, 2026. The renewal keeps things running smoothly without extra costs or big changes, just more time to keep the quality high.