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CDER and CBER issued a joint data standards strategy on Monday, detailing how the centers will develop and use data standards to review pre- and post-market safety and efficiency data through fiscal year 2022. Read More
Leaders of the House Energy and Commerce Committee sent a letter to FDA Commissioner Scott Gottlieb Friday asking him to investigate contradictory data on available supplies of heparin, and explain the agency’s plans for dealing with product quality and possible shortages. Read More
Philippine health officials investigating the anti-dengue vaccine Dengvaxia announced Friday that the drug may be linked to the deaths of three children. Read More
New York’s attorney general is suing Insys for deceptive marketing of the spray form of one of its fentanyl products, a move the state says is part of a multi-pronged strategy to address the addiction crisis. Read More
The FDA issued a black box warning for Ocaliva (obeticholic acid), a liver disease medication that was incorrectly dosed as daily instead of weekly for patients with primary biliary cholangitis (PBC), increasing the risk of serious liver injury and worsening liver problems. Read More
Medicare could have saved up to $3 billion over a five-year period if they used the same strategy employed by pharmacy benefit managers for privately-insured patients to favor generics, according to a research letter published in JAMA Internal Medicine. Read More