Master Protocols proposed by FDA

FDA’s Woodcock proposes master protocols, infrastructure to increase clinical trial efficiency, reduce costs

The FDA, which has successfully reduced the review times for new medications, wants to help biopharmaceutical companies lower the rising costs of clinical trials by streamlining some of its processes and working more closely with industry. That’s the proposal Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), outlined to senators on the Health Education Labor and Pensions committee end of April 2015.

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