FDA Releases Draft Guidance on Letters To Physicians Regarding Drug Safety

The Food and Drug Administration released a draft guidance for industry Nov. 10 providing recommendations on “dear health care provider” (DHCP) letters that drug manufacturers send to physicians to inform them about important new safety information.

FDA said the draft guidance provides recommendations on when to use a DHCP letter, the types of information to include, how to organize that information, and formatting techniques to make the information more accessible. A notice announcing the draft guidance, Dear Health Care Provider Letters: Improving Communication of Important Safety Information, was published Nov. 12 in the Federal Register (75 Fed. Reg. ...