Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance titled "Drug Safety Information-- FDA's Communication to the Public." This draft guidance updates and revises the March 2007 guidance entitled "Drug Safety Information-- FDA's Communication to the Public." This draft guidance describes FDA's current approach to communicating important drug safety information, including emerging drug safety information, to the public and the factors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 the information is communicated. The draft guidance was developed in connection with the Center for Drug Evaluation and Research's (CDER's) Safety First Initiative.