21 CFR 314.235
§ 314.235 Judicial review.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 314.235, § 314.235 Judicial review, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86382
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.