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US law
Federal (United States)
Regulations
Title 21 CFR — Food and Drugs
Chapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Part 314 — APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart E — Hearing Procedures for New Drugs
Federal (United States) · Regulations
Subpart E — Hearing Procedures for New Drugs
3 sections
3 sections
21 C.F.R. § 314.200
Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.
21 C.F.R. § 314.201
Procedure for hearings.
21 C.F.R. § 314.235
Judicial review.
Subpart E — Hearing Procedures for New Drugs | Federal (United States) Regulations | Justis AI