21 CFR 312.20: Requirement for an IND
Requires sponsors to submit an IND before conducting a covered clinical investigation of an investigational drug, not start until it is in effect, and file a separate IND for informed-consent-exception studies needing FDA written authorization.
Part 312, Investigational New Drug Application · Subpart B, Investigational New Drug Application (IND)
Recent 483s citing 312.20
- Hennepin County Medical Center, Dept Of Emergency Medicine · Minneapolis, MinnesotaThe sponsor failed to submit an IND to the FDA prior to conducting a clinical… Apr 26, 2019
- Lauren R. Klein, MD, MS, Sponsor-Investigator · Minneapolis, MinnesotaThe sponsor failed to submit an IND to the FDA prior to conducting a clinical… Apr 23, 2019
The regulation text
§ 312.20 Requirement for an IND.
(a)A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigation with an investigational new drug that is subject to § 312.2(a).
(b)A sponsor shall not begin a clinical investigation subject to § 312.2(a) until the investigation is subject to an IND which is in effect in accordance with § 312.40.
(c)A sponsor shall submit a separate IND for any clinical investigation involving an exception from informed consent under § 50.24 of this chapter. Such a clinical investigation is not permitted to proceed without the prior written authorization from FDA. FDA shall provide a written determination 30 days after FDA receives the IND or earlier.
[52 FR 8831, Mar. 19, 1987, as amended at 61 FR 51529, Oct. 2, 1996; 62 FR 32479, June 16, 1997]
Questions
What does 21 CFR 312.20 require?
Requires sponsors to submit an IND before conducting a covered clinical investigation of an investigational drug, not start until it is in effect, and file a separate IND for informed-consent-exception studies needing FDA written authorization.
Which sections are cited alongside 312.20?
In the same 483s, investigators most often also cite 312.50 (General responsibilities of sponsors), 312.60 (General responsibilities of investigators), 312.62 (Investigator recordkeeping and record retention), 312.66 (Assurance of IRB review).