{"data":{"id":"us/21-cfr-314.235","jurisdiction":"us","citation":"21 CFR 314.235","heading":"Judicial review.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG","Subpart E—Hearing Procedures for New Drugs"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"6e26e29458aaad898fdc3bce46c644eaea75dd078900330cfae985786f1dd98a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-314.201","next":"us/21-cfr-314.410"},"notice":"GroundRules: Original legal text. Not legal advice."}