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.
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