[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.235]

[Page 165-166]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents
 
               Subpart E--Hearing Procedures for New Drugs
 
Sec. 314.235  Judicial review.

    (a) The Commissioner of Food and Drugs will certify the transcript 
and record. In any case in which the Commissioner enters an order 
without a hearing under Sec. 314.200(g), the record certified by the 
Commissioner is required to include the requests for hearing together 
with the data and information submitted and the Commissioner's findings 
and conclusion.

[[Page 166]]

    (b) A manufacturer or distributor of an identical, related, or 
similar drug product under Sec. 310.6 may seek judicial review of an 
order withdrawing approval of a new drug application, whether or not a 
hearing has been held, in a United States court of appeals under section 
505(h) of the act.

Subpart F  [Reserved]