Guidance on Drug Safety Information-Food and Drug Administration's Communication to the Public; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance titled "Drug Safety Information--FDA's Communication to the Public." This guidance describes FDA's current approach to communicating important drug safety information, including emerging drug safety information, to the public and the factors that influence when such information is communicated. This guidance was developed in connection with FDA's Drug Safety Initiative. This guidance is the final version and supersedes the previously issued draft guidance titled "FDA's Drug Watch for Emerging Drug Safety Information" (70 FR 24606, May 10, 2005).