FDA Seeks Feedback on Updating IND Application Information Requirements
Published Date: 8/17/2026
Notice
Summary
The FDA is updating how it collects info for Investigational New Drug (IND) applications, which doctors and researchers use to test new or unapproved drugs. They want your feedback by September 16, 2026, to make sure the process is clear and efficient. This update affects anyone running clinical drug studies and aims to keep things smooth without adding extra costs or delays.
Analyzed Economic Effects
4 provisions identified: 0 benefits, 3 costs, 1 mixed.
Large Annual Reporting & Recordkeeping Burden
FDA estimates very large annual burden hours from IND reporting and recordkeeping: for human drugs, 23,016,423 reporting hours and 2,832,742 recordkeeping hours annually; for biologics, 6,694,050 reporting hours and 127,220 recordkeeping hours annually. These totals reflect the cumulative time respondents spend on the listed 21 CFR part 312 activities each year.
Electronic IND Submission & Web Interface
Information for INDs must be submitted electronically and FDA offers a new web-based interface (mobile or desktop) to help complete and electronically submit Form FDA 1571 and associated files. Individuals may request printed forms by email, but fees may apply for printed copies.
Form FDA 1571 Adds RWE/RWD Fields
If you file an IND using Form FDA 1571, the form was updated to include new real‑world evidence/real‑world data (RWE/RWD) tracking fields per the PDUFA VII commitment. FDA says these new fields will capture submissions that include RWE/RWD so the Agency can track and report on related performance.
Right to Try Annual Report Due March 31
Sponsors and manufacturers who provide an "eligible investigational drug" under the Right to Try Act must submit an annual report using Form FDA 5023 by March 31 each year covering the preceding calendar year. FDA lists this requirement under 21 CFR 300.200.
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