Draft Guidances for Industry on Improving Information About Medical Products and Health Conditions; Availability; Reopening of Comment Period

Samenvatting

The Food and Drug Administration (FDA) is reopening until August 10, 2004, the comment period for the draft guidances entitled "Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements," "Help-Seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms," and "Consumer-Directed Broadcast Advertising of Restricted Devices." FDA published a notice of availability of the draft guidances in the Federal Register of February 10, 2004 (69 FR 6308). FDA is taking this action in response to requests for an extension and to allow interested parties additional time to submit comments.