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 Senate is considering a bill that would prohibit the federal government from restricting the sale and use of experimental, unapproved drugs for fatal illnesses. Read More
The House Committee on Energy and Commerce is examining the FDA’s Office of Criminal Investigations (OCI) over a variety of case management concerns. Read More
The FDA doesn’t have explicit penalties for failing to self-identify as a generic facility, but noncompliance can raise the likelihood of a pre-approval inspection, the agency said in a guidance document. Read More
Diabetes drugs carry special development challenges and can be the riskiest sector in pharmaceuticals, with one in 13 investigational drugs achieving U.S. approval, according to a report from the Tufts Center for the Study of Drug Development. Read More
The FDA will decide whether to require a Risk Mitigation and Evaluation Strategy after weighing known and potential adverse events, the seriousness of the condition, and the drug’s expected benefits, according to a draft guidance to industry. Read More
The U.S. Court of Appeals for the Federal Circuit affirmed the validity of Abbott’s protein-binding patent, handing yet another victory to the company in a decades-long dispute with Yeda Research and Development. Read More