[Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2008] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR314.201] [Page 162] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF PART 314_APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG-- Table of Contents Subpart E_Hearing Procedures for New Drugs Sec. 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.