§ 1114.25 Communication between FDA and applicants.
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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
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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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