21 CFR Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION

Authority:

21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.

Source:

52 FR 8831, Mar. 19, 1987, unless otherwise noted.

Editorial Note:

Nomenclature changes to part 312 appear at 69 FR 13717, Mar. 24, 2004.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

U.S. Code: Title 21 - FOOD AND DRUGS

§ 321 - Definitions; generally

§ 331 - Prohibited acts

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 353 - Exemptions and consideration for certain drugs, devices, and biological products

§ 355 - New drugs

§ 360bbb - Expanded access to unapproved therapies and diagnostics

§ 371 - Regulations and hearings

U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 262 - Regulation of biological products