Postmarket Safety

Vermont Becomes Latest State to Take on Zohydro

Two new challenges emerged last week to the controversial drug Zohydro ER, as Vermont became the second state to slap restrictions on the drug and U.S. Attorney General Eric Holder announced he would look into the way the FDA approved the product. Read More

EU Industry Calls for More Dialogue on Proposed Pharmacovigilance Fees

While manufacturers support a strong pharmacovigilance system to ensure patient safety, the proposed costs are a source of concern, “especially in light of the annual saving for the pharmaceutical industry of 145 million euros (US $201 million) that was anticipated in the 2008 European Commission ‘impact assessment,’” a coalition of five trade groups says. Read More