The FDA says it is undertaking a new initiative to develop a system to query a broad range of databases to identify possible post-marketing adverse events.
An FDA plan to allow drug companies to distribute reprints of journal articles dealing with off-label drug uses has run into fire from Sen. Charles Grassley (R-IA), Public Citizen and two university professors even as an industry coalition began efforts in April to have the FDA loosen its proposal.
The FDA has a stale and outdated regulatory system for overseeing clinical trial compliance, but several initiatives are under way to modernize it, according to Division of Scientific Investigations director Leslie Ball.
FDA commissioner Andrew von Eschenbach was directed to “stop the buzzwords and toe-dancing” during intense, aggressive questioning by House Energy and Commerce chairman John D. Dingell (D-MI) at an acrimonious Oversight and Investigations Subcommittee hearing on the agency’s inability to prevent the entry of contaminated products.
Three key leaders of the House Energy and Commerce Committee are circulating a discussion draft of their proposed Food and Drug Administration Globalization Act of 2008.
The worst idea on Capitol Hill right now involves giving the FDA control of tobacco.
Appropriated funds for Office of Generic Drugs dries up
June 1, 2008
4:26 pm
FDA’s Office of Generic Drugs ran out of appropriated funds April 3 and a hiring freeze was imposed.
FDA identifies 20 drugs that need approved risk eval, strategy
June 1, 2008
4:25 pm
FDA identified 20 Rx drugs and biologics that must have an approved risk evaluation and mitigation strategy, including GlaxoSmith-Kline’s Lotronex, Novartis’ Clozaril, Cephalon’s Actiq, Hoffmann-LaRoche’s Accutane, Celgene’s Revlimid and Thalomid, Danco’s Mifeprex and Biogen Idec’s Tysabri.
Report: 71% of promised postmarketing commitments aren’t started
June 1, 2008
4:22 pm
FDA’s latest annual report says 71% (911) of pending postmarketing study commitments promised by drug sponsors at the time of approval have never been started.
FDA commissioner says agency could easily absorb $100M
June 1, 2008
4:20 pm
Commissioner von Eschenbach told an April Senate hearing his agency could easily absorb an extra $100 million for FY 2009 to beef up medical product and food safety operations.