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The agency warned sponsors that recent technological innovations make it easy for other parties to easily deduce a patient’s identity from deidentified trial data. Read More
Acting FDA Commissioner Brett Giroir said the biosimilar and interchangeable insulin products should increase access and reduce costs of insulin products. Read More
The FDA handed the medication breakthrough therapy, fast track, orphan drug, and rare pediatric disease designations, as well as priority review. Read More
Healthcare regulators have set their sights on type 2 diabetes drug metformin to see if it contains unsafe amounts of N-nitrosodimethylamine (NDMA). Read More
House Speaker Nancy Pelosi announced yesterday that drug pricing measure H.R. 3 is headed to a House floor vote next week, where it is expected to pass. But because there is no Senate companion measure, there is unlikely to be final legislation on drug pricing this year. Read More
Most of the new draft guidances are aimed at oral formulations, while most of the revised guidances are aimed at topical and transdermal formulations. Read More