Senate HELP Innovate-A-Palooza

Politico, March 9, 2016. The National Center for Health Research is concerned that the Innovation Act, including the MEDTECH bill, will endanger patient safety by reducing FDA oversight.

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PhRMA: Easing Speech Limits Could Reduce Need for Subgroups in Trials

InsideHealthPolicy.com, March 7, 2016. While minority, patient and consumer groups pushed for more diversity in the clinical trial phase, Jocelyn Ulrich director of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), said matching demographic subgroups based on sex, age and race, specifically the African American and Hispanic populations, to disease prevalence would extend phase III clinical trials by 20 months or longer.

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