21 CFR § 314.201 Applications for FDA Approval to Market a New Drug

§ 314.201 Procedure for hearings.

Current through Sep 8, 2026 · Read all of Part 314

⚠ 4 pending changes to Part 314

Parts 10 through 16 apply to hearings relating to new drugs under section 505 (d) and (e) of the act.

← § 314.200 Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.§ 314.235 Judicial review. →