§ 1114.25 - Communication between FDA and applicants.

Related Notices
- 2021-21011. Final rule. 2021-21011. Premarket Tobacco Product Applications and Recordkeeping Requirements
- 2019-20315. Proposed rule. 2019-20315. Premarket Tobacco Product Applications and Recordkeeping Requirements

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§ 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.

                    
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§ 1114.25 - Communication between FDA and applicants.

§ 1114.25 Communication between FDA and applicants.