21 CFR 312.50
General responsibilities of sponsors
21 CFR 312.50 is the regulation titled “General responsibilities of sponsors” in 21 CFR Part 312, Investigational New Drug Application. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 312.305, in 1 letter
- Closed out
- 50% of these letters have a published close-out
Letters citing it, by year issued
Most are biologics letters (1 of 2). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
The regulation
Read the text of 21 CFR 312.50 (eCFR, as of Sep 1, 2026)
Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug. Additional specific responsibilities of sponsors are described elsewhere in this part.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 312.50.
- 21 CFR 312.305Requirements for all expanded access uses1 letter cites both
- 21 CFR 312.310Individual patients, including for emergency use1 letter cites both
- 21 CFR 312.33Annual reports1 letter cites both
- 21 CFR 312.57Recordkeeping and record retention1 letter cites both
- 21 CFR 312.60General responsibilities of investigators1 letter cites both
- 21 CFR 312.66Assurance of IRB review1 letter cites both
- 21 CFR 56.104Exemptions from IRB requirement1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 312.50 that FDA posted most recently.
- BiologicsView Amy Lightner, MDinvestigational product under IND (b)(4)IssuedMar 25, 2025PostedJun 3, 2025
- DrugsView Angela D. Ritter, M.D.investigational drug (b)(4)IssuedJun 7, 2024PostedJun 18, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.