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FDA officials briefed members of the Drug Safety Oversight Board (DSOB) about safety activities in the Office of Drug Safety and the role of drug safety in the Office of New Drugs during the DSOB’s second meeting last month.
Merck has been sued by the Texas attorney general for allegedly bilking the state out of millions of dollars in Medicaid payments by downplaying the cardiovascular risks of its now-withdrawn pain drug Vioxx.
Drug labeling should contain clearly written information that allows prescribers and patients to make sense of the product’s risks and benefits, an expert in risk management told the Drug Information Association (DIA) conference.
CVS no longer will purchase pharmaceuticals from wholesalers that trade in the secondary market, which has been identified as an entry point for counterfeit and adulterated drugs.
Providing patients with a more realistic view of the risks and benefits of prescription drugs, as well as targeting new drugs to patients who are most likely to benefit, could help resolve many of the drug-safety problems plaguing the industry, according to an executive with a large pharmaceutical benefit manager (PBM).
Risk management plays a critical role in determining an investigator's approach to a current good manufacturing practice (cGMP) inspection, dictating everything from how the inspection is conducted to who is placed on the investigative team, FDA officials told a recent industry conference.
The FDA could issue a decision soon on Barr Pharmaceuticals’ application to turn its emergency contraceptive Plan B OTC, said the agency’s acting Commissioner Lester Crawford.
A trio of final guidance documents focused on developing new ways to minimize the safety risks of prescription drugs and biologics are not expected to lengthen the product- approval process, a top FDA official said.
The European Medicines Agency (EMEA) has imposed sweeping restrictions on Cox-2 inhibitor drugs, which include labeling changes and warnings for the controversial drug class.