Senate approves brain cancer research Bill

Tuesday, May 31, 2016

The Senate Committee on Appropriations has approved legislation that provides for the inclusion of “brain cancer” among the disorders eligible for study by the Department of Defense‘s (DoD) Peer Reviewed Cancer Research Program (PRCRP). This provision was included in the fiscal year 2017 Defense Appropriations Act, and mirrors action taken by the House on May 11 to add brain cancer to the PRCRP in its version of the Defense Appropriations Act.

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FDA’s proposed Expanded Access Navigator points to progress, not panacea

Monday, May 23, 2016

In response to the increasing demand for access to investigational drugs, creation of a clearinghouse to provide information on the request process has been proposed by the Reagan-Udall Foundation for the FDA. Dubbed the Expanded Access (EA) Navigator, the educational tool is the government’s latest effort to increase the efficiency of the complex process of requesting unapproved drugs outside of clinical trials for “compassionate use.”

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IRBs react to new model for registering proposed gene trials

Monday, May 2, 2016

On April 27, the National institutes of Health (NIH) enacted a new administrative model for the review of proposed human gene trials; the new guidelines upend a process that has been in place for more than 40 years. Predictably, reaction throughout the industry is mixed. Larger firms are adjusting quickly to the change and retooling their processes to comply with the new model. At the other end of the spectrum, some IRBs, including IntegReview, declined to comment on the changes, stating that the matter is still under internal review.

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