In January of 2016, a Phase I drug trial in France, conducted by the French contract research organization Biotrial, left one volunteer dead and five others hospitalized: four with permanent neurological damage. The drug, named BIA 10-2474, is under development, by...
A Notice of Proposed Rulemaking (NPRM) released 8 Sep 2015 outlines revisions to the Common Rule (45 CFR 46 subpart A) meant to modernize, strengthen, and make it more effective. The most significant changes to the Common Rule proposed in the NPRM are as follows:...
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