21 CFR Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
- Subpart A - General Provisions (§§ 314.1 - 314.3)
- Subpart B - Applications (§§ 314.50 - 314.90)
- Subpart C - Abbreviated Applications (§§ 314.92 - 314.99)
- Subpart D - FDA Action on Applications and Abbreviated Applications (§§ 314.100 - 314.170)
- Subpart E - Hearing Procedures for New Drugs (§§ 314.200 - 314.235)
- Subpart F [Reserved]
- Subpart G - Miscellaneous Provisions (§§ 314.410 - 314.445)
- Subpart H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses (§§ 314.500 - 314.560)
- Subpart I - Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible (§§ 314.600 - 314.650)
{'United States Code': [{'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': '355a', 'headtext': ' Pediatric studies of drugs', 'cleanpath': '/uscode/text/21/355a'}, {'Title': '21', 'Section': '355f', 'headtext': ' Extension of exclusivity period for new qualified infectious disease products', 'cleanpath': '/uscode/text/21/355f'}, {'Title': '21', 'Section': '356', 'headtext': ' Expedited approval of drugs for serious or life-threatening diseases or conditions', 'cleanpath': '/uscode/text/21/356'}, {'Title': '21', 'Section': '356a', 'headtext': ' Manufacturing changes', 'cleanpath': '/uscode/text/21/356a'}, {'Title': '21', 'Section': '356b', 'headtext': ' Reports of postmarketing studies', 'cleanpath': '/uscode/text/21/356b'}, {'Title': '21', 'Section': '356c', 'headtext': ' Discontinuance or interruption in the production of life-saving drugs', 'cleanpath': '/uscode/text/21/356c'}, {'Title': '21', 'Section': '356e', 'headtext': ' Drug shortage list', 'cleanpath': '/uscode/text/21/356e'}, {'Title': '21', 'Section': '360cc', 'headtext': ' Protection for drugs for rare diseases or conditions', 'cleanpath': '/uscode/text/21/360cc'}, {'Title': '21', 'Section': '371', 'headtext': ' Regulations and hearings', 'cleanpath': '/uscode/text/21/371'}, {'Title': '21', 'Section': '374', 'headtext': ' Inspection', 'cleanpath': '/uscode/text/21/374'}, {'Title': '21', 'Section': '379e', 'headtext': ' Listing and certification of color additives for foods, drugs, devices, and cosmetics', 'cleanpath': '/uscode/text/21/379e'}, {'Title': '21', 'Section': '379k-1', 'headtext': ' Electronic format for submissions', 'cleanpath': '/uscode/text/21/379k-1'}], 'Statutes at Large': [], 'Public Laws': [], 'Presidential Documents': []}