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A European Union court ruled that the European Medicines Agency can offer access to clinical trial data in a blow to three drugmakers who argued this would hurt their business. Read More
CDER denied a fourth petition from United Therapeutics calling on the center to impose additional conditions before approving ANDAs for combination products that reference its pulmonary arterial hypertension drug Tyvaso unless they meet specific conditions and measured up to the original in terms of performance and bioequivalence. Read More
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
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