Inpharma 1475 - 19 Feb 2005

US FDA to create new Drug SafetyOversight Board

The US FDA has announced that it is to create a newindependent Drug Safety Oversight Board to overseethe management of drug safety issues.

This is part of a new vision for the FDA, designed topromote a culture of "openness and enhanced oversightwithin the Agency", with focus on making the FDA’sreview and decision-making processes "moreindependent and transparent". The new board willcomprise members of the FDA, other Health andHuman Services (HHS) agencies and governmentdepartments, and will be appointed by the FDAcommissioner, with the board to consult other medicalexperts and representatives of patient and consumergroups.

Additionally, the FDA is to establish new, and expandexisting, communication channels to provide "targeteddrug safety information to the public", to ensure thatboth established and emerging safety data are rapidlyavailable and easily accessible. The Agency has alsoproposed the development of a ‘Drug Watch’ websitefor emerging drug and risk information, with increaseduse of consumer-friendly information sheets for bothpatients and health professionals.Food and Drug Administration. FDA Improvements in Drug Safety Monitoring.Media Release : 15 Feb 2005. Available from: URL: http://www.fda.gov 809045290

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Inpharma 19 Feb 2005 No. 14751173-8324/10/1475-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved