Inpharma 1475 - 19 Feb 2005 US FDA to create new Drug Safety Oversight Board The US FDA has announced that it is to create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues. This is part of a new vision for the FDA, designed to promote a culture of "openness and enhanced oversight within the Agency", with focus on making the FDA’s review and decision-making processes "more independent and transparent". The new board will comprise members of the FDA, other Health and Human Services (HHS) agencies and government departments, and will be appointed by the FDA commissioner, with the board to consult other medical experts and representatives of patient and consumer groups. Additionally, the FDA is to establish new, and expand existing, communication channels to provide "targeted drug safety information to the public", to ensure that both established and emerging safety data are rapidly available and easily accessible. The Agency has also proposed the development of a ‘Drug Watch’ website for emerging drug and risk information, with increased use of consumer-friendly information sheets for both patients 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 1 Inpharma 19 Feb 2005 No. 1475 1173-8324/10/1475-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

US FDA to create new Drug Safety Oversight Board

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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