21 C.F.R. § 314.235 Judicial review.
Title 21 - Food and Drugs
(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 §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. (b) A manufacturer or distributor of an identical, related, or similar drug product under §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.
Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart E—Hearing Procedures for New Drugs
§ 314.235 Judicial review.
