FDA Tagged Articles
Medical device makers to pay more for product safety reviews
The Food and Drug Administration (FDA) is doubling its fees to medical device makers who want their products reviewed in order to market them in the United States. The increase will allow the federal agency to hire 200 new full-time
New recommendations for Gardasil vaccine may put boys at risk
Despite outcry from parents of girls who have received the HPV vaccine Gardasil, and criticism about the vaccine’s effectiveness from one of its own creators, this month the American Academy of Pediatrics endorsed its use for boys. This follows a
Four common drugs cause most emergency hospitalizations, CDC says
A new study conducted by researchers from the U.S. Centers for Disease Control and Prevention (CDC) has found that four common prescription drugs – two blood thinners and two diabetes medications – are responsible for the majority of emergency room
FDA moves back review date for new drug containing Actos
Japanese drug maker Takeda Pharmaceuticals Co. will have to wait even longer to hear if the Food and Drug Administration (FDA) will approve its two experimental diabetes medications. The decision was expected by Jan. 25, 2012, but federal regulators have
Gardasil marketing: putting the profit cart before the proof horse?
On first glance, a study published by drug manufacturer Merck & Co., in the New England Journal of Medicine appears to declare the Gardasil vaccine a resounding success. The pharmaceutical giant points to numbers that show its cervical cancer vaccine
UC doctor finds statin drugs may cause anger, hostility in rare cases
Some people taking Pfizer’s smoking-cessation drug Chantix have reportedly experienced fits of hostility. Anti-depression medications and other drugs that work to modify brain activity have also been linked to episodes of violent behavior. But what about statins, the drugs commonly
