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CDRH should add new "cross-cutting collaborative product groups" to its structure to help it deal with the total product life cycles of the devices it regulates, an advisory team has recommended.
The long and controversial Plan B approval may by over for Barr Pharmaceuticals, but trouble for the Bush Administration over its handling of the matter continues.
The use of genetic testing to develop personalized dosing for medicines can save lives and potentially billions of dollars, a group of FDA officials says.
Public comments obtained from the FDA’s Division of Dockets Management show that while many organizations are generally supportive of the agency’s draft guidance on conducting emergency clinical research without informed consent from participants, more work needs to be done.
The biotechnology industry is focusing its lobbying efforts in the 110th Congress on ensuring that the FDA has sufficient appropriations and user fees to perform timely reviews of new products, an industry official says.
The Bush administration’s nomination of Andrew von Eschenbach to be the FDA commissioner faces an uncertain future that has less to do with the new Democratic Senate leadership than it does with members of the president’s own party.
With the Democrats taking control of the House of Representatives for the first time since 1994, the healthcare agenda will now be in the hands of some very vocal critics of HHS policy regarding drug safety and effectiveness, FDA oversight and drug prices, particularly in Medicare.
The Bush administration’s nomination of Andrew von Eschenbach to be the FDA commissioner faces an uncertain future that has less to do with the new Democratic Senate leadership than it does with members of the president’s own party.
Presumptive Speaker of the House Rep. Nancy Pelosi’s (D-Calif.) plan to address concerns about her proposal to give the government authority to negotiate Medicare Part D drug prices was met with a mix of criticism and skepticism by industry observers.