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GUIDANCE DOCUMENT

Dear Health Care Provider Letters: Improving Communication of Important Safety Information January 2014

Download the Final Guidance Document Read the Federal Register Notice
Final Level 2 Guidance
Docket Number:
FDA-2010-D-0319
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

OMB Control Number: 0910-0001
Expiration Date: 03/31/2024

This guidance provides recommendations to industry and FDA staff on the content and format of Dear Health Care Provider (DHCP) letters.2 DHCP letters are correspondence ― often 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 about important new or updated information regarding a human drug or biologic (hereafter “drug” and “product” refer to both biologic and small molecule drug products). DHCP letters may also be distributed by email and are often made available on the Internet (e.g., on company Web sites or through patient advocacy groups). This guidance provides recommendations on (1) when to issue a DHCP letter, (2) the types of information to include in a DHCP letter, (3) how to organize that information so that it is communicated effectively to health care providers, and (4) formatting techniques to make the information more accessible.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2010-D-0319.

 
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