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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.
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.
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the FDA’s Division of Dockets Management show that while many organizations are generally supportive of the agency’s draft guidance on conducting emergency clinical research without informed consent from participants, more work needs to be done.
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the FDA’s Division of Dockets Management show that while many organizations are generally supportive of the agency’s draft guidance on conducting emergency clinical research without informed consent from participants, more work needs to be done.
Data from preclinical animal experiments that preceded the calamitous clinical trial of the experimental gene therapy TGN1412 suggest that the drug should have been classified as higher risk than it actually was, and the trial participants should have received a lower dose, according to two researchers writing in the UK medical journal The Lancet.
Activists have filed a claim in federal circuit court challenging the FDA’s decision that vaccines and other products containing the mercury-based preservative thimerosal are safe.
Activists are planning to file a claim in federal circuit court challenging the FDA’s decision that vaccines and other products containing the mercury-based preservative thimerosal are safe.
Until more information is known about the exact health risks presented by nanotechnology, the federal government needs to use a sliding scale to determine potential harm, a former federal official says.
Data from preclinical animal experiments that preceded the calamitous clinical trial of the experimental gene therapy TGN1412 suggest that the drug should have been classified as higher risk than it actually was, and the trial participants should have received a lower dose, according to two researchers writing in the UK medical journal The Lancet.
Industry sources are dismissing the call by five current and former members of the FDA’s Drug Safety and Risk Management Advisory Committee for Congress to improve the agency’s drug safety system as nothing new.