Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled "Dear Health Care Provider Letters: Improving Communication of Important Safety Information." This guidance offers specific recommendations to industry on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. This guidance provides recommendations on when to use a DHCP letter, the types of information to include in the DHCP letter, how to organize the information so that it is communicated effectively to health care providers, and formatting techniques to make the information more accessible. This guidance finalizes the draft guidance issued in November 2010.