C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG › Subpart E—Hearing Procedures for New Drugs

21 C.F.R. § 314.201

Procedure for hearings

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