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Manufacturers and industry groups urged the FDA to develop guidance on its processes for assigning a lead center for the quality review of a combination product. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency laid out its top 10 priorities for 2017 and 2018 — including ensuring GMP compliance and quality throughout supply chains. Read More
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