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Former FDA deputy commissioner Scott Gottlieb emerged as the favorite to serve as the next FDA commissioner in a survey of 53 pharmaceutical companies. Read More
The HHS secretary recently delivered FDA’s recommendations for reauthorizing user fees covering prescriptions, generic drugs and biosimilars to Congress, before the body begins to craft a legislative package due by the end of September. Read More
The European Parliament’s committee on Environment, Public Health and Food Safety voted to approve a draft report that includes dozens of recommendations for improving how the EU promotes access to medicine and handles safety, intellectual property, and pricing issues. Read More
The Office of Management and Budget clarified President Trump’s new “one in, two out” regulations order, narrowing its scope to significant regulations with an economic impact of over $100 million per year, and new guidance documents considered on a case-by-case basis. Read More
A European Medicines Agency committee proposed changes to clarify ambiguities in an international draft guideline for non-clinical studies of oncology drugs. Read More
Two congressmen sent a letter to the CEO of Marathon Pharmaceuticals, calling the company’s decision to market an old drug for Duchenne muscular dystrophy for $89,000 per year as “outrageous” and “unconscionable.” Read More