FDA Approvals - Tuft's report backs FDA fast-track, but post-marketing concerns loom (Nature)
Tuft's report backs FDA fast-track, but post-marketing concerns loom (Nature)
A new report from the Center for the Study of Drug Development at Tufts University in Boston, published in March, suggests that the pressure has let up and that the fast-track program has sped drug approvals.
St. Jude Medical Announces Regulatory Approvals and Market Launch of the QuickSite XL Lead (Business Wire via Yahoo! Finance)
ST. PAUL, Minn.----May 2, 2006--St. Jude Medical, Inc. today announced U.S. Food and Drug Administration approval, receipt of European CE Mark clearance and market launch of the QuickSite XL bipolar, left-heart lead to treat heart failure patients.