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FDA Indefinitely Delays Action on Regulating Laboratory Developed Tests

On November 18, 2016, the Food and Drug Administration (FDA) notified industry groups that it no longer plans to finalize its draft guidance on laboratory developed tests (LDTs). FDA stated that it intends to work with the...more

One Step Away: European Parliament Approves New Clinical Trials Regulation

On April 2, 2014, the European Parliament approved the new clinical trials regulation (the “Regulation”) for the European Union (“EU”), with 594 votes in favor, 17 opposed and 13 abstentions. The European Parliament approved...more

4/8/2014  /  Clinical Trials , EU
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