# 21 CFR § 1114.25: Communication between FDA and applicants

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.25

## Section

- **Citation:** 21 CFR § 1114.25
- **Heading:** Communication between FDA and applicants
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER K—TOBACCO PRODUCTS > PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS > Subpart C—FDA Review

## Text

During the course of reviewing an application, FDA may communicate with an applicant about relevant matters, including scientific, medical, and procedural issues that arise during the review process and inspections. These communications may take the form of telephone conversations, letters, electronic communications, or meetings, and will be documented in the administrative file in accordance with § 10.65 of this chapter.

## Nearby sections

- [21 CFR § 1114.1 § 1114.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.1.md)
- [21 CFR § 1114.3 § 1114.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.3.md)
- [21 CFR § 1114.5 § 1114.5 Application submission.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.5.md)
- [21 CFR § 1114.7 § 1114.7 Required content and format.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.7.md)
- [21 CFR § 1114.9 § 1114.9 Amendments.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.9.md)
- [21 CFR § 1114.11 § 1114.11 Withdrawal by applicant.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.11.md)
- [21 CFR § 1114.13 § 1114.13 Change in ownership of an application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.13.md)
- [21 CFR § 1114.15 § 1114.15 Supplemental applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.15.md)
- [21 CFR § 1114.17 § 1114.17 Resubmissions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.17.md)
- [21 CFR § 1114.25 § 1114.25 Communication between FDA and applicants.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.25.md)
- [21 CFR § 1114.27 § 1114.27 Review procedure.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.27.md)
- [21 CFR § 1114.29 § 1114.29 FDA action on an application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.29.md)
- [21 CFR § 1114.31 § 1114.31 Issuance of a marketing granted order.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.31.md)
- [21 CFR § 1114.33 § 1114.33 Issuance of a marketing denial order.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.33.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.25. Check the current official text before relying on it. Not legal advice.