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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
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.
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The outgoing chairman of the Senate committee with jurisdiction over the FDA is calling on his colleagues to confirm Andrew von Eschenbach as the agency's commissioner before the end of the 109th Congress to provide the leadership necessary to change what he calls an agency in turmoil. Read More
Pending industry user fee reauthorization will strongly shape the FDA's likely effort to use regulatory action to preempt legislative fixes for a number of issues in the next Congress, sources say. Read More
In its first major announcement since the midterm elections gave control of the next Congress to the Democrats, the FDA outlined what it believes should be the priorities to improve drug safety without sacrificing innovation. Read More
Softlens Technology cannot sell its tinted, noncorrective contact lenses without prescriptions or fittings from eyecare professionals, an FDA warning letter said. Read More
The FDA has revised industry guidance on device tracking, noting that manufacturers are not required to track devices unless the agency has issued them an order to do so. Read More
Fourteen years after silicone gel-filled breast implants were pulled from the market due to safety concerns, the FDA Nov. 17 announced it had approved marketing for two brands of the devices. Read More
The FDA’s tentative agreement with drug and biotechnology companies to accept fees in exchange for quicker reviews of direct-to-consumer (DTC) ads is prompting criticism from industry observers who believe the plan is both a conflict of interest and a violation of the First Amendment. Read More
The combination of a closely split Senate, a Republican president and an upcoming presidential election in 2008 will likely add up to gridlock in the nation’s capital, numerous experts say. Read More