21 CFR 1114.25

§ 1114.25 Communication between FDA and applicants.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 1114.25, § 1114.25 Communication between FDA and applicants, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91543
Permanent ID: ys:prov:91543@1
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Full 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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.