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No one expects Sidney Wolfe to sit on his hands at an FDA advisory committee meeting, and at his first outing as a permanent member of the Drug Safety & Risk Management Advisory Committee, he didn’t disappoint.

On August 8, the FDA made Sid Wolfe, the long-standing consumer advocate at Public Citizen Health Research Group and a well-known thorn in the side of the pharmaceutical industry, a permanent four-year member of the Drug Safety & Risk Management Advisory Committee.

On August 8, the FDA made Sid Wolfe, the long-standing consumer advocate at Public Citizen Health Research Group and a well-known thorn in the side of the pharmaceutical industry, a permanent four-year member of the Drug Safety & Risk Management Advisory Committee.

Our Favorite Titles The File: A Personal History by Timothy Garton Ash Timothy Garton Ash’s “The File” is a journey into the author’s two-inch-thick Stasi intelligence file that the East German police accumulated on him during his study as a graduate student in East Berlin.

Type 2 diabetes just entered the new era of drug development. FDA’s Endocrine & Metabolic Drugs Advisory Committee’s recommended (by a 14-2 vote) that cardiovascular safety become a standard requirement for type 2 diabetes drug candidates.

FDA advisory committee meetings are not supposed to be like episodes of the Jerry Springer show. And for good reason: One is a scientific discussion of the benefit-risk profile of new drug or indication. The other is a television tabloid talk show with topics in such poor taste that our own corporate content filters won’t even let us access the website.

Cephalon CEO Frank Baldino’s characterization of the May 6 FDA advisory committee review of Fentora (fentanyl buccal tablets) as “challenging” is a masterpiece of understatement. Here is the crux of Baldino’s post-mortem on the failed attempt to get a major label expansion for the pain control product