Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

概要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers." This revised draft guidance, when finalized, will describe FDA's current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. This guidance revises and replaces the draft guidance for industry entitled "Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices" issued in June 2014. This revised draft guidance is not final nor is it in effect at this time.