Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 89

The FDA created an internal Drug Safety Oversight Board (DSB) in 2005. The DSB was subsequently mandated by the FDA Amendments Act of 2007 and advises CDER Center Director on handling and communicating important and emerging drug safety issues, especially regarding how such issues impact federal healthcare delivery and payment systems. The DSB is composed of representatives from two FDA Centers and eight other federal government agencies, the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), Department of Defense (DOD), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Department of Veterans Affairs (VA). An important role of the DSB is to help FDA assess the impact of their safety decisions on the healthcare systems of its Federal Partners. The Board, with its broad representation from federal healthcare organizations, can provide valuable input and allows FDA to hear varied perspectives on drug safety issues.

Monthly meeting minutes and outcome reports are available online.