TAILIEUCHUNG - drug safety fda has begun efforts to enhance postmarket safety

Tham khảo sách 'drug safety fda has begun efforts to enhance postmarket safety', công nghệ thông tin, kỹ thuật lập trình phục vụ nhu cầu học tập, nghiên cứu và làm việc hiệu quả | GAO November 2009 United States Government Accountability Office_ Report to the Ranking Member Committee on Finance . Senate DRUG SAFETY FDA Has Begun Efforts to Enhance Postmarket Safety but Additional Actions Are Needed b GAO Accountability Integrity Reliability GAO-10-G8 November 2000 DRUG SAFETY A GA o AccourU6iiry r ag er K la3 ry Highlights HWffghui or GAO-10-68 a report to rw RŨìtong Member Committee on Fnance. US Sonata Why GAO Did This study There have been long-standing concerns regarding the Food and Drug Administration s FDA oversight of post mat kit drug safety. In 2006 GAO report rd that FDA had not clearly defined the roles of two offices involved In making decisions about ỊXIK1 market safety the Office of New Drags OND ami the Office of Surveillance and Epidemiology OSE . GAO and others reported additional concerns such as limitations ill the data FDA relics on to identify post market drag safety Issues and the systems it uses to track such issues. At that time. GAO made recommendations Including that FDA improve the independence of its program for resolving scientific disputes related to postmarket drug safety. In 2007. Irgedation further expanded FDA s post market responsibilities This report examines the steps that FDA is taking to 1 enhance its processes for making decisions about the safety of marketed drags. 2 improve ÍICCVSS to data that help the agency Identify drag safety issues and 3 build its capacity to fulfill its M stm irkrt drug safety workload. GAO reviewed FDA policies and planning documents and interviewed FDA officials. What GAO Recommends GAO recommends that FDA develop a comprehensive plan to prepare OSE for the transfer of additional regulatory authorities from ONI . FDA agreed with GAO s recommendation. Vtew GAO-10-68 or key cccponcou For more mtoưTMlon contact Marcia Croa e at 202 512-7114 or crosscm FDA Has Begun Efforts to Enhance Postmarket Safety but Additional Actions Are Needed What GAO Found FDA is .

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