eCFR :: 21 CFR Part 312 -- Investigational New Drug Application
WEBView Title 21 on govinfo.gov; View the PDF for 21 CFR Part 312; These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR. Learn more.
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
WEBMar 22, 2024 — For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 312.1 - Scope. § 312.2 - Applicability. § 312.3 - Definitions and interpretations. §...
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
WEBMar 22, 2024 — Sec. 312.21 Phases of an investigation. An IND may be submitted for one or more phases of an investigation. The clinical investigation of a previously untested drug is generally divided...
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
WEBMar 22, 2024 — Additional specific responsibilities of sponsors are described elsewhere in this part. Sec. 312.52 Transfer of obligations to a contract research organization. (a) A sponsor may...
21 CFR Part 312 - LII / Legal Information Institute
WEBElectronic Code of Federal Regulations (e-CFR) 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
21 CFR §312 Investigational New Drug Application - Code of …
WEBPART 312 - INVESTIGATIONAL NEW DRUG APPLICATION Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
21 CFR Part 312 Subpart I -- Expanded Access to Investigational …
WEBThis subpart contains the requirements for the use of investigational new drugs and approved drugs where availability is limited by a risk evaluation and mitigation strategy (REMS) when the primary purpose is to diagnose, …
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
WEBMar 22, 2024 — CHAPTER I--FOOD AND DRUG ADMINISTRATION. DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER D - DRUGS FOR HUMAN USE. Subpart A - General Provisions. Authority: 21 U.S.C. 321, 331, 351,...
WEBPART 312—INVESTIGATIONAL NEW DRUG APPLICATION. Subpart A—General Provisions. Sec. 312.1 Scope. 312.2 312.3 312.6. Applicability. Definitions and interpretations. Labeling of an investigational new drug. 312.7 Promotion of investigational drugs. 312.8 Charging for under an IND. 312.10 Waivers. investigational. drugs.
Federal Regulations for Clinical Investigators | FDA - U.S. Food and ...
WEBPart 312 of section 21 covers investigational new drug application regulations, including regulations for clinical investigators. 312.60 General Responsibilities of Investigators. 312.61...