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Sens. Enzi, Kennedy Introduce Bill That Would Give FDA More Authority Over Drug Safety
Sens. Michael Enzi (R-Wyo.) and Edward Kennedy (D-Mass.) on Thursday introduced a bill that would provide FDA with more authority to monitor the safety of new prescription drugs and encourage additional research on such medications, CQ HealthBeat reports (CQ HealthBeat, 8/3). The bill would require pharmaceutical companies to agree with FDA on a "Risk Evaluation and Management Strategy," which would include an annual review of new medications for three years. Under the provision, pharmaceutical companies would have to file with FDA 15-day, quarterly and annual reports on adverse events related to new medications, as well as a plan "to assess known serious risks and to identify unexpected serious risks." REMS also could require postmarket, or Phase IV, clinical trials and could include restrictions on direct-to-consumer advertisements for new medications. In addition, the legislation would establish a Drug Safety Oversight Board to mediate disputes between FDA and pharmaceutical companies over REMS. The bill would establish the Reagan-Udall Institute for Applied Biomedical Research -- funded initially by the federal government and later by a combination of federal, industry and philanthropic funds -- to consider proposals to reduce the time required to assess the safety of new medications. The legislation also would require pharmaceutical companies to post the results of Phase III and Phase IV clinical trials in a public database (Kaiser Daily Health Policy Report, 7/20). Comments
Enzi said that the bill would "raise the bar to ensure that drug safety is not an afterthought but an integral part of the process from the very beginning." He added, "It requires drug makers to engage in better safety planning before a drug is approved for release to the public" and would "improve both the understanding of and response to risks that arise after a drug is on the market." Kennedy said that the public database of clinical trial results would "help patients and their health care providers make better informed decisions about treatment" (CQ HealthBeat, 8/3).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Sens. Enzi, Kennedy Introducerea Bill care vor da FDA Mai mult autoritatea asupra consumului de droguri de siguranþã - Sens. Enzi, Kennedy Introduce Bill That Would Give FDA More Authority Over Drug Safety - articole medicale engleza - startsanatate
