US lawFederal (United States)RegulationsTitle 21 CFR — Food and DrugsChapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 314 — APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUGSubpart E — Hearing Procedures for New Drugs314.20121 C.F.R. § 314.201Procedure for hearings.Last amended: 2016Year: 2026Length: 20 wordsOfficial source Cite as 21 C.F.R. § 314.201 (2026)Parts 10 through 16 apply to hearings relating to new drugs under section 505 (d) and (e) of the act.Previous21 C.F.R. § 314.200Next21 C.F.R. § 314.235