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The FDA is looking into ultimately moving to an all-electronic submission system for regulatory information in all its divisions and will hold a public hearing on the proposal next month. Read More
The FDA's response to concerns about its pedigree rule does not go far enough to protect smaller wholesalers or the public, industry sources say. Read More
President Bush's nomination of Andrew von Eschenbach to be the next FDA commissioner is at a stalemate as the agency and Sen. Chuck Grassley (R-Iowa) battle over access to an ongoing clinical trial investigation, an FDA source says. Read More
The FDA’s decision to grant conflict of interest waivers for two-thirds of the voting members of an advisory committee proves that the agency is not following Congress’ or the Institute of Medicine’s (IOM) directives to minimize such conflicts, sources say. Read More
The FDA will hold a public meeting to discuss labeling designs for intravenous (IV) drug products in an effort to minimize medication errors and improve patient safety. Read More
The FDA has instructed AstraZeneca to stop distributing a professional sales aid for its antipsychotic Seroquel because it lacks appropriate risk information for the drug, according to an agency warning letter. Read More
Herceptin can now be used with chemotherapy to treat HER2-positive breast cancer patients after surgery to reduce relapses, the FDA announced. Read More
In the latest round of scrutinizing sanofi-aventis’ antibiotic Ketek, the FDA is holding a joint advisory meeting to address potential health risks associated with the drug. Read More