21 CFR 514.235
§ 514.235 Judicial review.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 514.235, § 514.235 Judicial review, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86973
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Full text
(a) The transcript and record shall be certified by the Commissioner. In any case in which the Commissioner enters an order without a hearing pursuant to § 314.200(g) of this chapter, the request(s) for hearing together with the data and information submitted and the Commissioner's findings and conclusions shall be included in the record certified by the Commissioner.
(b) Judicial review of an order withdrawing approval of a new drug application, whether or not a hearing has been held, may be sought by a manufacturer or distributor of an identical, related, or similar drug product, as defined in § 310.6 of this chapter, in a United States court of appeals pursuant to 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.