After spending almost a decade at some of the world’s most successful healthcare companies, I’m making the atypical journey back to the agency side, and that has me thinking about what in-house experience brings to the agency table.
Janet Woodcock was named to a newly created position as FDA chief medical officer in a management reshuffle that brings in John Dyer to hold her previous titles.
Genentech has sent a “dear doctor” letter to warn about a higher risk for stroke in patients taking 0.5 mg of Lucentis, indicated for treating wet age-related macular degeneration.
Bayer settles with 30 states over Baycol marketing
Bayer has reached a settlement with 30 states to resolve a consumer protection enforcement action over the marketing of Baycol, a cholesterol-lowering drug withdrawn from the market in 2001.
Public Citizen’s Wolfe says Medtronic’s DTC campaign is misleading
Public Citizen Health Research Group head Sidney Wolfe says Medtronic’s new DTC ad campaign on sudden cardiac arrest is highly misleading and tries to frighten people into getting $30,000 heart defibrillators implanted.
Cell Therapeutics reaches agreement with government
Cell Therapeutics has reached agreement with the federal government to pay $10.5 million to resolve the investigation of its business practices in marketing the cancer drug Trisenox (arsenic trioxide).
FDA drug and biologic user fees will jump almost 30% next year—from about $300 million to almost $400 million in 2008, according to details released about the PDUFA 4 negotiations.
Schering Sales Corp., a division of Schering-Plough, will pay $435 million in connection with Medicaid fraud and illegal sales and marketing programs under a Jan. 17 court sentence.
Outgoing Senate Finance Committee chair Chuck Grassley (R-IA) has written HELP Committee leaders with a laundry list of FDA shortcomings that he hopes they will address.
FDA commissioner Andrew von Eschenbach on Jan. 30 unveiled a comprehensive series of steps now being undertaken in direct response to last September’s Institute of Medicine report that sharply criticized the FDA’s drug safety program and that recommended changes to the nation’s drug safety system.