The CenterWatch Weekly, April 11, 2016
FDA’s postmarket oversight of expedited drugs found lacking
The FDA lacks reliable, readily accessible data on potential safety issues needed to meet postmarket safety responsibilities and to conduct systematic oversight of new drugs. This was the conclusion of a recent report issued by the U.S. Government Accountability Office (GAO). The GOA found that the FDA’s Center for Drug Evaluation and Research’s (CDER) internal data evaluations have problems with completeness and accuracy. These problems prevent the timely publication of legally required postmarket studies and reports on tracked safety issues—potential safety concerns the FDA determined to be significant, and which the FDA monitors using an internal database.
Collaborative Cancer Cloud expands to drive medicines to patients faster
The Dana-Farber Cancer Institute (DFCI) of Boston and the Ontario Institute for Cancer Research (OICR) in Toronto have joined the Collaborative Cancer Cloud, a partnership formed in August 2015 by the Knight Cancer Institute at Oregon Health and Science University (OHSU) of Portland, Oregon, and Intel. By allowing research institutions to securely share genomic, imaging and clinical data on a precision medical analytics platform, the Collaborative Cancer Cloud is positioning itself to make rapid strides in cancer research and lifesaving therapies.
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