FDA Approvals - FDA decision on new Wyeth drug postponed (Sharewatch) The Food
FDA decision on new Wyeth drug postponed (Sharewatch)
The Food and Drug Administration was scheduled to make a decision next week on Pristiq, the first non-hormonal drug to treat hot flashes and other menopausal symptoms.
NEJM Publishes Several Perspectives On FDA User Fee Reauthorization, Prescription Drug Safety (Medical News Today)
Drug Safety Reform at the FDA -- Pendulum Swing or Systematic Improvement?" New England Journal of Medicine: In the perspective, former FDA Commissioner Mark McClellan discusses an Institute of Medicine report that focused on FDA drug approval and postmarket safety and how recommendations could affect user fee reauthorization (McClellan, NEJM, 4/13). [click link for full article]
Boston Scientific Gets FDA Acuity OK (AP via Yahoo! Finance)
Medical device maker Boston Scientific Corp. said Tuesday that the Food and Drug Administration approved one of its heart device leads, its first new product since the agency lifted a hold on company approvals.