DIA Biosimilars 2013

Pew Health Group

Pew Health urges Congress to reauthorize PDUFA

Monday, February 6, 2012 08:38 AM

Allan Coukell, director of medical programs at the Pew Health Group, issued a statement concerning a U.S. House energy and commerce subcommittee on health hearing on the reauthorization of the Prescription Drug User Fee Act (PDUFA IV), which has shortened the pharmaceutical approval process by the FDA.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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