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
-
A
Subpart A—General Provisions Sections 314.1–314.3 -
B
Subpart B—Applications Sections 314.50–314.90 -
C
Subpart C—Abbreviated Applications Sections 314.92–314.99 -
D
Subpart D—FDA Action on Applications and Abbreviated Applications Sections 314.100–314.170 -
E
Subpart E—Hearing Procedures for New Drugs Sections 314.200–314.235 -
F
Subpart F [Reserved] -
G
Subpart G—Miscellaneous Provisions Sections 314.410–314.445 -
H
Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses Sections 314.500–314.560 -
I
Subpart I—Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible Sections 314.600–314.650