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The FDA said Sept. 29 that babies exposed during the first three months of pregnancy to the drug Lamictal, which is used to treat epileptic seizures and bipolar disorder, may have a higher chance of being born with a cleft lip or cleft palate.
Just over a week after an FDA advisory committee decided Bayer Pharmaceuticals' blood-loss prevention drug Trasylol was safe and effective, the agency said study data Bayer just revealed shows the drug increases the risk of death, stroke, heart failure and kidney damage.
The FDA will partner with Duke University’s Clinical Research Institute and other public and private entities to develop biomarkers identifying potential cardiac side effects from certain drugs and devices.
FDA officials are acknowledging problems with its handling of drug safety issues in their response to the Institute of Medicine’s (IOM)
report “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”
While the U.S. heads the global pack in nanotechnology research, not enough money is being spent on studying the environmental, health and safety (EHS) risks nanotechnology presents, according to a report by the National Research Council assessing the National Nanotechnology Initiative (NNI)for Congress.
The FDA will be working with Duke University’s Clinical Research Institute to develop biomarkers identifying potential cardiac side effects from certain drugs and devices.
Baxter should change the labels on two heparin products to clearly differentiate the version used to treat adults from the one used to treat premature infants, but a broader solution would be to implement a label universal to all products routinely used in infants, according to a lawyer representing families of two babies that died after receiving the wrong dosage of the drug.
The FDA has issued more information about its Oct. 10 public meeting on nanotechnology, making arrangements for what it apparently expects to be a large crowd, according to details of the notice.
Clinical investigators (CIs) should be prepared for a number of specific criteria FDA inspectors look for in an audit, according to the FDA's Rhonda Mecl.
Sponsors of device trials must word their agreements with investigators and sites even more carefully in certain areas than sponsors of drug trials, according to a speaker at the FDA Clinical Trial Requirements Conference in Minneapolis.