21 CFR Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

Authority:

21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 371, 374, 379e, 379k-1.

Source:

50 FR 7493, Feb. 22, 1985, unless otherwise noted.

Editorial Note:

Nomenclature changes to part 314 appear at 69 FR 13717, Mar. 24, 2004; 81 FR 69639, Oct. 6, 2016.

{'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': []}