PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Editorial Note:
Nomenclature changes to part 314 appear at 69 FR 13717, Mar. 24, 2004; 81 FR 69639, Oct. 6, 2016.
Subparts
-
Subpart A
Subpart A—General Provisions -
Subpart B
Subpart B—Applications -
Subpart C
Subpart C—Abbreviated Applications -
Subpart D
Subpart D—FDA Action on Applications and Abbreviated Applications -
Subpart E
Subpart E—Hearing Procedures for New Drugs -
Subpart F
Subpart F [Reserved] -
Subpart G
Subpart G—Miscellaneous Provisions -
Subpart H
Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses -
Subpart I
Subpart I—Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible