Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled "Dear Health Care Provider Letters: Improving Communication of Important Safety Information." Dear Health Care Provider (DHCP) Letters are correspondence--usually in the form of a mass mailing from the manufacturer or distributor of a human drug or biologic, or from FDA--intended to alert physicians and other health care providers to important new information about a marketed drug or biological product. This draft guidance provides recommendations on when to use a DHCP letter, the types of information to include in a DHCP letter, how to organize that information, and formatting techniques to make the information more accessible. The draft guidance is intended to improve the quality of DHCP letters to make them more effective communication tools for new information about marketed products.