Opening Product Labeling To Broader CE Data Is Proposed In Senate Bill
Drug product labels could contain an array of comparative effectiveness data beyond well-controlled clinical trials, if Sens. Jack Reed, D-R.I., and Barbara Mikulski, D-Md., get their way
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Study of "format variations" in the brief summary of print advertisements will test different ways of presenting benefit and risk information.
Study will consider how different formats for communicating quantitative efficacy could affect consumers' understanding of print and TV ads.
Formally at the user fee negotiation table for the first time, the advocacy group wants new drugs to be tested against the "best practice" for treating a disease.