FDA Updates Paperwork for Radioactive Drug Studies
Published Date: 4/17/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about radioactive drug research committees. This affects researchers using radioactive drugs for basic studies and aims to keep paperwork clear and up-to-date. You’ve got until June 16, 2026, to share your comments—no extra costs, just your voice!
Free Policy Watch
New rules are filed every week. Most people never see them.
Pick a topic. PRIA watches every federal rule and tells you when one hits your household.
Pick a topic to get started
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
FDA Authorization Required First
If you conduct basic human research using radioactive drugs, you cannot give those drugs to people unless an FDA-approved Radioactive Drug Research Committee (RDRC) authorizes the study under 21 CFR 361.1(d)(7). Studies under RDRC must be basic research (for example, studies of metabolism or human physiology) and not clinical trials for safety or effectiveness; clinical trials require filing an IND under 21 CFR part 312.
Reporting and Recordkeeping Burden
RDRC chairs and investigators must keep minutes, meet at least quarterly when activity occurs, and submit annual reports using Form FDA 2914 (Membership Summary) and Form FDA 2915 (Study Summary). FDA estimates annual reporting at 1,194 hours total and annual recordkeeping at 2,443 hours total (combined 3,637 hours), and notes an overall decrease of 52 hours and 97 responses versus prior estimates.
Consent and Pregnancy Testing Rules
Investigators must obtain the required informed consent from research subjects, and every female subject of childbearing potential must either state in writing that she is not pregnant or be confirmed not pregnant by a pregnancy test under 21 CFR 361.1(d)(5).
Adverse Event Reporting Requirement
Investigators must immediately report all adverse effects associated with the radioactive drug to the RDRC, and the RDRC must report to FDA adverse reactions probably attributed to the drug under 21 CFR 361.1(d)(8).
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Take It Personal
Get Your Personalized Policy View
Start a Free Government Policy Watch to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in