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.
FDA Commissioner Scott Gottlieb is leaving the agency on Friday to rejoin the American Enterprise Institute—a conservative think tank—where he will work part-time on drug pricing issues. Read More
The FDA is also seeking $76 million to support drug compounding activities and develop new regulations to improve the quality of products from outsourcing facilities. Read More
FDA Commissioner Scott Gottlieb and CBER director Peter Marks on Wednesday announced enforcement efforts the agency is taking against stem cell clinics and manufacturers that put patients at risk by marketing unapproved products. Read More
The FDA’s proposed guidance on Risk Evaluation Mitigation Strategies will be much easier for brand-name drugmakers to implement than for generic manufacturers, the Association for Accessible Medicines says. Read More
Outgoing FDA Commissioner Scott Gottlieb highlighted plans for drug compounding enforcement among the agency’s drug priorities in his final testimony before House appropriators on Wednesday. Read More
When a drug can be used safely in pediatric populations, it should be made clear in the drug’s “indications and usage” section, the agency says. Read More
The FDA will require a black box label to warn patients of the risk of high blood pressure and an increase in the risk of heart attack and other side effects. Read More