---
kind: "section"
citation: "21 C.F.R. § 514.235"
title: "21"
number: "514.235"
heading: "Judicial review."
url: "https://uscodex.org/cfr/21/514.235"
---

# §514.235. Judicial review.

- (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)](/cfr/21/314.200.md?p=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](/cfr/21/310.6.md) of this chapter, in a United States court of appeals pursuant to [section 505(h)](/cfr/21/505.md?p=h) of the act.

## Notes

### Amendments

[42 FR 4717, Jan. 25, 1977]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 360ccc, 360ddd, 360ddd-1, 371, 379e, 381.

### Source

Source: 40 FR 13825, Mar. 27, 1975, unless otherwise noted.

### Amendments

[42 FR 4717, Jan. 25, 1977]