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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter K - Tobacco Products |
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Part 1114 - Premarket Tobacco Product Applications |
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Subpart C - FDA Review |
§ 1114.25 - Communication between FDA and applicants.
Latest version.
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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.