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CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG > SUBPART E—Hearing Procedures for New Drugs (§314.200 to §314.235) > 314.201—Procedure for hearings.
314.201—Procedure for hearings.
Parts 10 through 16 apply to hearings relating to new drugs under section 505 (d) and (e) of the act.