Healthy Skepticism Library item: 8764

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Publication type: report

Center for Drug Evaluation and Research
Guidance: Drug Safety Information – FDA’s Communication to the Public
Rockville, MD: US Food and Drug Administration 2007 Mar
http://web.archive.org/web/20090511234243/http://www.fda.gov/cder/guidance/7477fnl.pdf

Abstract:

This document provides guidance on how FDA is developing and disseminating information to the
public regarding important drug safety issues, including emerging drug safety information.2 As
discussed in more detail below, an important drug safety issue is one that has the potential to alter the benefit/risk analysis for a drug in such a way as to affect decisions about prescribing or taking the drug. The term emerging drug safety information refers to information about an important drug safety issue that has not yet been fully analyzed or confirmed.

For many years, FDA has provided information on drug risks and benefits to healthcare
professionals and patients when that information has generated a specific concern or prompted a
regulatory action, such as a revision to the drug product’s labeling. More recently, FDA has begun
taking a more comprehensive approach to making information on potential drug risks available to
the public earlier, in some cases while the Agency still is evaluating whether any regulatory action
is warranted. FDA believes that timely communication of important drug safety information will
give healthcare professionals, patients, consumers, and other interested persons access to the most
current information concerning the potential risks and benefits of a marketed drug, helping them to
make more informed individual treatment choices.

This Guidance3 describes FDA’s current approach to communicating important drug safety
information, including emerging drug safety information, to the public and the factors that
influence when such information is communicated. FDA may disseminate important drug safety
information by other methods and at other times than those described in this guidance.