# 21 C.F.R. § 314.235 (2026): Judicial review

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P314_S314_235

## Section

- **Citation:** 21 C.F.R. § 314.235 (2026)
- **Heading:** Judicial review
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 314: APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG / Subpart E: Hearing Procedures for New Drugs / § 314.235: § 314.235   Judicial review.

## 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.

## Nearby sections

- [21 C.F.R. § 314.200 (2026) § 314.200   Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P314_S314_200.md)
- [21 C.F.R. § 314.201 (2026) § 314.201   Procedure for hearings.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P314_S314_201.md)
- [21 C.F.R. § 314.235 (2026) § 314.235   Judicial review.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P314_S314_235.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P314_S314_235. Check the current official text before relying on it. Not legal advice.