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 [...]

Abbott Laboratories will reach its market share goals for its drug-coated Xience V stent, analysts said Thursday. Read More Permalink[...]

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 [...]

Yes, it's FDA Intern! Strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of Janet Woodcock or even FDA commish Andy von Eschenbach! FDA Intern! Who can change the course of mighty clinical trials, approve drug ads faster than a speeding [...]

An FDA panel of outside medical experts said the agency should raise standards for approving diabetes drugs, a move that could affect the $5 billion-plus diabetes drug market in the U.S.[...]