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.

{'United States Code': [{'Title': '42', 'Section': '262', 'headtext': ' Regulation of biological products', 'cleanpath': '/uscode/text/42/262'}, {'Title': '21', 'Section': '321', 'headtext': ' Definitions; generally', 'cleanpath': '/uscode/text/21/321'}, {'Title': '21', 'Section': '331', 'headtext': ' Prohibited acts', 'cleanpath': '/uscode/text/21/331'}, {'Title': '21', 'Section': '351', 'headtext': ' Adulterated drugs and devices', 'cleanpath': '/uscode/text/21/351'}, {'Title': '21', 'Section': '352', 'headtext': ' Misbranded drugs and devices', 'cleanpath': '/uscode/text/21/352'}, {'Title': '21', 'Section': '353', 'headtext': ' Exemptions and consideration for certain drugs, devices, and biological products', 'cleanpath': '/uscode/text/21/353'}, {'Title': '21', 'Section': '355', 'headtext': ' New drugs', 'cleanpath': '/uscode/text/21/355'}, {'Title': '21', 'Section': '360bbb', 'headtext': ' Expanded access to unapproved therapies and diagnostics', 'cleanpath': '/uscode/text/21/360bbb'}, {'Title': '21', 'Section': '371', 'headtext': ' Regulations and hearings', 'cleanpath': '/uscode/text/21/371'}], 'Statutes at Large': [], 'Public Laws': [], 'Presidential Documents': []}