{"data":{"id":"us/21-cfr-312.20","jurisdiction":"us","citation":"21 CFR 312.20","heading":"Requirement for an IND.","body":"(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).\n(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 312—INVESTIGATIONAL NEW DRUG APPLICATION","Subpart B—Investigational New Drug Application (IND)"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"d6a5ff0ed8157aabb8257793ca8bc4c81fb4f987d79c51fe8d2d0d1c718222b3","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-312.10","next":"us/21-cfr-312.21"},"notice":"GroundRules: Original legal text. Not legal advice."}