Collecting and Providing 702(b) Portions of Food and Drug Administration Official Samples-Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

概要

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry and FDA staff entitled "Collecting and Providing 702(b) Portions of FDA Official Samples-- Questions and Answers." This draft guidance is intended to assist industry and FDA staff with issues and questions related to the requirements for FDA to collect and provide a part of an official sample of an article to any person named on the label of the article, or the owner thereof, or his attorney or agent.