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Two compounders forfeited their exemptions as compounding pharmacies from certain FDA rules because they made products that were not formulated in response to prescriptions for individual patients, the agency said. Read More
In anticipation of the passage of PDUFA VI, the FDA called on drug companies to notify agency officials of any PDUFA eligible products and Orange Book changes involving their products by the end of August. Read More
More than 120 questions and answers were added to the European Medicines Agency’s FAQs on the launch of the new EudraVigilance reporting system, set to go live Nov. 22. Read More
Drugmakers need to provide adequate details — and include narratives — in describing manufacturing processes in their applications, but can leave out elements such as machinery serial numbers and general GMPs, according to the European Medicines Agency. Read More
China’s high court called for severe criminal punishments for deliberately falsifying drug clinical trial reports and other related documents, issuing a judicial interpretation that takes effect Sept. 1. Read More
EMA began forming assessment teams across the European Union in 2015 to include initial marketing applications and coordination of scientific advice procedures. Read More