Boston Scientific Corp. announced Wednesday that the U.S. Food and Drug Administration has approved the company's Promus drug-coated coronary stent.[...]
Drug developers Wyeth and Progenics Pharmaceuticals Inc. said Thursday European regulators approved Relistor as a treatment for constipation related to pain drugs taken by terminally ill patients. Read More Permalink[...]
Harvard University professor Daniel Carpenter has come out with a revised version of a study concluding that drugs moving too quickly through the FDA approval process are more likely to be linked to safety problems later. Though admitting to data mistakes in his original study, he stands behind his original [...]
Not surprisingly, the editors of The New England Journal of Medicine say 'yes.' Preemption, you may recall, is the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on [...]
A Harvard University professor defended research suggesting the FDA was too hasty in approving drug, which the agency has criticized as mistaken, The Wall Street Journal writes. The professor, Daniel Carpenter, acknowledged that the FDA had identified mistakes in his study, which was published by the New England Journal of [...]
The agreement between the Office of New Drugs and the Office of Surveillance & Epidemiology spells out which unit will take the lead on specific safety issues. And for drugmakers, this is going to be a big change, because the OSE, which was never viewed by pharma as an ally [...]
