Reactions 1138 - 10 Feb 2007

US FDA reports new steps in drugsafety

The US FDA has outlined a commitment to the safetyof drugs and other medical products in a report that alsoresponds to recommendations made by the Institute ofMedicine (IOM) in 2006.1

Following consideration of the IOMrecommendations and advice from other experts, theFDA plans to strengthen the drug safety system withsteps that would support three key efforts:• strengthening the science supporting the FDA’s

medical product safety system at all stages of theproduct life-cycle,

• improving information flow and communicationamong all stakeholders involved in promoting thesafe use of medical products, and

• improving management and operations to ensureimplementation of the processes required tostrengthen the US drug safety system.

The FDA says that its ongoing efforts in drug safetycomprise a comprehensive approach to the IOM’srecommendations. Part of the process has involved theFDA signing a memorandum of understanding with theVeterans Health Administration in the US Department ofVeterans Affairs to share expertise and informationregarding the review and use of FDA-regulated drugs,medical devices and biologicals.2 Goals of thepartnership are to evaluate ways to enhance riskcommunication and the collection of postmarketmedical product safety data through strongerinteragency activities, and to promote efficient use ofexpertise and tools for medical product riskidentification, analysis and validation.1. FDA. FDA Reinforces Commitment to Drug Safety. Media Release : 30 Jan

2007. Available from: URL: http://www.fda.gov.2. FDA. FDA and VA to Share Information on the Safe Use of Medical Products.

Media Release : 30 Jan 2007. Available from: URL: http://www.fda.gov.800996805

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Reactions 10 Feb 2007 No. 11380114-9954/10/1138-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved