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The European Medicines Agency and the European Commission published new track-and-trace safety requirements Feb. 10 affecting all drugmakers doing business in EU countries. Read More
An FDA advisory committee gave South Korea’s Celltrion’s biosimilar candidate for Remicade a strong show of support Feb. 9, backing its approval for six indications. Read More
European officials are pushing for greater synchronicity between the U.S. and EU regulators on generic approval processes as part of broader trade negotiations. Read More
With 12 nations signing off on the Trans-Pacific Partnership, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics. Read More
Regular price reevaluations can lower drug prices in individual European countries, but the only way to ensure significant price cuts is through EU-wide collaboration, according to a new report. Read More
Cynthia Schnedar, director of CDER’s Office of Compliance, is leaving to pursue opportunities in the private sector, Janet Woodcock said Monday in an emailed message. Her last day will be March 18. Read More