| [Code of Federal Regulations] |
| [Title 21, Volume 5] |
| [Revised as of April 1, 2012] |
| [CITE: 21CFR314.201] |
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CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES |
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| SUBCHAPTER D--DRUGS FOR HUMAN USE |
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PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart E--Hearing Procedures for New Drugs
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Sec. 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.
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