We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA’s advisory committee system is flawed because of a slant toward approving drugs, even when there are significant concerns about those products’ safety, an activist group concludes in an Aug. 28 report.
The FDA is warning consumers not to buy prescription drugs from certain Canadian websites that are reportedly selling counterfeit drugs, and not to use such drugs if they have purchased them.
The government’s ability to wrest a $435 million settlement from a major drug company based on a single warning letter is a development that could signal significant future problems for the industry, a former FDA official says.
The FDA has been denied two of its central strategies in regulating compounded drugs by a federal court decision that could undermine future agency efforts to regulate this practice, industry sources said.
The FDA’s advisory committee system is slanted toward approval of drugs, even when there are significant concerns about those products’ safety, an activist group concludes in an Aug. 28 report.
Barr Pharmaceuticals may be only weeks away from FDA approval to sell its controversial contraceptive Plan B OTC after resubmitting its application and apparently meeting the agency’s demands.
Merck’s losses in federal and state courts Aug. 17 signal not only flaws in the company’s legal strategy in fighting thousands of lawsuits involving its pain-relief drug Vioxx, but also more liability than originally anticipated, a financial analyst says.
The FDA is delaying its decision on Genentech’s supplemental biologics license application (sBLA) for the breast cancer drug Herceptin for three months because of an amendment to the company’s original application.
Global pharmaceutical drug sales have remained steady over the past several months, averaging 5 percent growth, healthcare consultant IMS Health reported.