Draft Guidances for Industry on Improving Information About Medical Products and Health Conditions; Withdrawal; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of three draft guidances for industry designed to improve information provided to consumers and health care practitioners by medical product firms about medical products and health conditions. The three guidances are entitled: "Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements" (Brief Summary Guidance), "Help-Seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms" (Disease Awareness Guidance), and "Consumer-Directed Broadcast Advertising of Restricted Devices " (Device Broadcast Advertising Guidance). FDA is also announcing the withdrawal of the draft guidance for industry entitled "Using FDA- Approved Patient Labeling in Consumer-Directed Print Advertisements."