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21 C.F.R. Part 314 – Applications for FDA Approval to Market a New Drug | Midpage
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Code of Federal Regulations
Title 21
Chapter I
Subchapter D
Part 314
21 C.F.R. Part 314
Applications for FDA Approval to Market a New Drug
A
General Provisions
B
Applications
C
Abbreviated Applications
D
FDA Action on Applications and Abbreviated Applications
E
Hearing Procedures for New Drugs
F
[Reserved]
G
Miscellaneous Provisions
H
Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
I
Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible