Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Revised Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers." This revised draft guidance, when finalized, will provide FDA's current thinking on common questions regarding certain communications by firms to health care providers (HCPs) of scientific information on unapproved use(s) of approved/ cleared medical products (the scope of the italicized terms is further explained in the revised draft guidance). This revised guidance supersedes the revised draft guidance entitled "Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices" issued in 2014 (2014 revised draft guidance).