Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024
§ 1114.25 - Communication between FDA and applicants.

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.

authority: 21 U.S.C. 371,374,387a,387i,387j; Pub. L. 117-103, 136 Stat. 49
source: 86 FR 55412, Oct. 4, 2021, unless otherwise noted.
cite as: 21 CFR 1114.25