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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
The FDA issued warning letters to two web site operators for selling misbranded and unapproved opioids online, ordering them to immediately cease selling the violative drugs to U.S. customers. Read More
Novartis finds itself in a tough spot after a federal judge refused the company’s request to toss a whistleblower lawsuit that could cost the Swiss-based pharma giant hundreds of millions of dollars. Read More
Increased transparency in the supply chain is the key to lowering insulin prices, patient advocates and health professional told members of the House Energy and Commerce committee on Tuesday. Read More