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EU Meeting Drug Review Goals But Lags U.S. in Drug Availability

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Despite successful performance goals for review times of new drugs in the EU, many drugs become available in the U.S. prior to the EU, according to a study by the Tufts Center for the Study of Drug Development (Tufts CSDD). The study found that mean approval times for new products approved in both the EU and the U.S. during 2000-05 were almost the same: 15.8 months for EMEA approved products and 15.7 months for those approved by the FDA. Recently enacted EMEA regulations such as conditional...

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