Presenting ... A Fresh Interpretation Of Old Policy

Law360, New York (March 19, 2012, 1:44 PM EDT) -- On Feb. 9, 2012, Dr. Robert Temple of the U.S. Center for Drug Evaluation and Research (CDER) gave a presentation[1] to the National Pharmaceutical Council about the potential uses of comparative effectiveness research (CER) results.

Temple addressed the “asymmetry” between the standard for promotional drug claims — substantial evidence — and CER results, and outlined ways that pharmaceutical manufacturers could potentially disseminate information about CER.

Significantly, his presentation provided an interpretation of section 114 of the U.S. Food and Drug Administration Modernization Act of 1997 (21...
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