21 CFR Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION
- Subpart A - General Provisions (§§ 312.1 - 312.10)
- Subpart B - Investigational New Drug Application (IND) (§§ 312.20 - 312.38)
- Subpart C - Administrative Actions (§§ 312.40 - 312.48)
- Subpart D - Responsibilities of Sponsors and Investigators (§§ 312.50 - 312.70)
- Subpart E - Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses (§§ 312.80 - 312.88)
- Subpart F - Miscellaneous (§§ 312.110 - 312.145)
- Subpart G - Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests (§ 312.160)
- Subpart H [Reserved]
- Subpart I - Expanded Access to Investigational Drugs for Treatment Use (§§ 312.300 - 312.320)
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': []}