---
kind: "section"
citation: "21 C.F.R. § 314.235"
title: "21"
number: "314.235"
heading: "Judicial review."
url: "https://uscodex.org/cfr/21/314.235"
---

# §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 [§ 314.200(g)](/cfr/21/314.200.md?p=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](/cfr/21/310.6.md) 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)](/cfr/21/505.md?p=h) of the act.

## Notes

### Source

Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted. Redesignated at 57 FR 17983, Apr. 28, 1992.

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1.

### Source

Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.