FDA Forced to Define 'Underway' Because Drug Companies Can't
Published Date: 1/7/2025
Notice
Summary
The FDA just dropped a draft guide to help drug makers understand when their important follow-up studies are officially 'underway' after getting accelerated approval. This affects companies racing to bring promising drugs to patients faster, making sure they stick to deadlines and prove their drugs really work. Comments on this draft are open until March 10, 2025, so industry folks have a chance to weigh in before the final rules land.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 1 costs, 1 mixed.
Confirmatory Trials May Need To Be Underway
If you are a sponsor of a drug granted accelerated approval, the FDA says it may require that confirmatory clinical trials be "underway" before approval or within a specified time after approval, under section 3210 of the Consolidated Appropriations Act, 2023. The draft guidance explains how FDA interprets "underway" and the factors it will consider when making that determination.
Regular 180-Day Postmarketing Progress Reports
Sponsors of approved drugs must submit postmarketing reports on the progress of required confirmatory trials approximately every 180 days, and FDA says it will use those reports to monitor trial progress and take action if needed. FDA also tentatively concludes that adding section 3210 of the CAA does not add information-collection requirements beyond existing statutes and regulations.
Draft Guidance Is Nonbinding; Flexibility Allowed
The FDA states the draft guidance reflects its current thinking but is not binding; you may use an alternative approach if it satisfies applicable statutes and regulations. The document is open for comment and, when finalized, will describe FDA's interpretation of "underway."
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