FDA Asks: Better Drug Trial Paperwork or Same Old Headache?
Published Date: 3/13/2026
Notice
Summary
The FDA wants your thoughts on how it collects info about new drug tests before they’re approved. This affects drug companies and researchers who submit applications to test new medicines. You’ve got until May 12, 2026, to share your comments, helping shape smoother, clearer rules without extra costs or delays.
Analyzed Economic Effects
5 provisions identified: 1 benefits, 4 costs, 0 mixed.
Large IND Reporting Burden
If you sponsor or run clinical drug trials, you must follow 21 CFR part 312 reporting and recordkeeping rules that FDA estimates generate millions of hours of annual burden: for human drugs FDA lists 152,856 total responses and 23,016,423 total annual hours, and for biologics FDA lists 48,179 total responses and 6,694,050 total annual hours.
New RWE/RWD Tracking Fields
Form FDA 1571 was updated to add tracking fields for real-world evidence and real-world data (RWE/RWD) under the PDUFA VII commitments so sponsors submitting RWE/RWD will provide those new data elements.
Electronic Submission Requirement
FDA requires that the information for INDs be submitted electronically (forms are available electronically; printed forms can be requested and fees may apply), so sponsors and investigators must use electronic submission channels for IND-related forms.
Form 1571 Web Interface Available
FDA offers a new web-based interface for completing and electronically submitting Form FDA 1571 from mobile devices or desktops, which lets sponsors (including sponsor-investigators) fill out and submit IND applications online.
Right to Try Annual Report Deadline
Sponsors and manufacturers who provide an "eligible investigational drug" under the Right to Try Act must submit an annual report using Form FDA 5023 no later than March 31 each year, covering data for the preceding calendar year.
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Key Dates
Department and Agencies
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