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# Provider Letter Guidance Out
- URL: https://www.fdaweb.com/provider-letter-guidance-out/
- Published: 2017-02-08T12:00:00.000Z
- Updated: 2026-09-14T22:05:22.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5137933

FDA has issued a guidance, *Dear Healthcare Provider Letters: Improving Communication of Important Safety Information*, to give industry recommendations on the content and format of Dear Healthcare Provider letters. Such letters, the [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM233769.pdf?ref=fdaweb.com) says, are intended to alert doctors and other healthcare providers about important new or updated information regarding a human drug or biologic. The guidance includes information on when to issue such a letter, the types of information to include in the letter, how to organize the information so that it is communicated effectively to healthcare providers, and formatting techniques to make the information more accessible.

The guidance notes a 2005 study that found wide variations in the extent to which information in a healthcare provider letter is accessible and can be understood. That study found a correlation between a letter’s quality or perceived quality and the extent to which doctors perceived the new information as important. “Letters that were evaluated as clearer, more concise, better organized and formatted, and that focused on the most important aspects of the new safety information were considered more effective in communicating the new information,” it says. The recommendations are based on some of the findings and recommendations in the 2005 study, the agency’s experience in evaluating healthcare provider letters, and the agency’s general risk communication experience.