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Sponsors should include clear assessments of necessary future quality improvement actions in their periodic safety update reports, not simply provide a list of adverse events or GMP problems, according to new guidance from the European Medicines Agency. Read More
Congress reached a deal late Sunday night on a comprehensive, 1,600-page bill to fund the federal government through September 30 — and give the FDA an extra $39 million. Read More
The U.S. Trade Representative flagged China and India on its latest priority watch list of countries with lax intellectual property protections for drugs. Read More
Congress reached a deal late Sunday night on a comprehensive, 1,600-page bill to fund the federal government through September 30 — and give the FDA an extra $39 million. Read More
More than a dozen states are considering drug price transparency bills — most recently in California, where a state senate committee voted to advance legislation requiring drugmakers to disclose operating costs. Read More