Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions-Accelerated Approval of Drugs and Biologics
Published Date: 2/6/2026
Notice
Summary
The FDA wants your thoughts on how it collects info about speeding up drug and biologic approvals for serious illnesses. This affects drug makers and patients waiting for faster access to important treatments. You’ve got until April 7, 2026, to share your comments—so don’t miss out on shaping the future of faster medicine approvals!
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
Big Time Burden for Drug Sponsors
If you are a drug or biologic sponsor, FDA estimates new paperwork will take about 400 hours to prepare for each Advisory Committee submission and about 40 hours to prepare a written appeal. FDA estimates two Advisory Committee submissions (800 hours) and one written appeal (40 hours) per year across the Agency, for a total of 3 responses and 840 hours.
Confirmatory Trial & 180-Day Reporting Rule
Under section 3210 of the Consolidated Appropriations Act, FDA may require that confirmatory studies be underway before approval or within a specified time after approval, and sponsors must submit postmarketing reports on the progress of required confirmatory trials approximately every 180 days.
Expanded Protections During Withdrawal Process
If FDA considers withdrawing an accelerated approval, the agency must give the sponsor due notice and an explanation, offer a meeting with the Commissioner or designee, allow a written appeal to an independent designee, provide an advisory committee meeting if requested, and allow public comment with a published summary of comments and FDA's response.
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Key Dates
Department and Agencies
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