21 C.F.R. § 314.201 Procedure for hearings.
Title 21 - Food and Drugs
Parts 10 through 16 apply to hearings relating to new drugs under section 505 (d) and (e) of the act.
Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart E—Hearing Procedures for New Drugs
§ 314.201 Procedure for hearings.