[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2002]
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

[[Page 166]]

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.
    (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]