Last week, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII (Clinical Trial Databases) of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The proposed rule clarifies requirements to clinical researchers for registering clinical trials and submitting summary trial results information to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine, part of the National Institutes of Health. The NIH also announced a proposal to apply the proposed requirements to all NIH-funded clinical trials, whether subject to FDAAA or not. The proposed policy would require that all NIH-funded clinical trials be registered in ClinicalTrials.gov and that summary results be posted to the database in a timely matter. Both documents are open for a 90-day public comment period, and comments will be taken into consideration before final regulations and a final NIH Policy are issued.
On Monday, the 2014 Nobel Prize in Physiology or Medicine was announced . The prize was awarded to a team of scientists for their discoveries of cells that constitute a positioning system — an “inner GPS” —in the brain that makes it possible to orient ourselves in space, demonstrating a cellular basis for higher cognitive function.
The prize of 8-million-Swedish-krona ($1.2-million USD) was divided, with one half to Dr. John O´Keefe, age 75, at at University College London and the other half jointly to a husband-and-wife team, Dr. May-Britt Moser, age 51, and Dr. Edvard I. Moser, age 52, at the Norwegian University of Science and Technology in Trondheim, for discovering how the brain creates a map of the space around us and how we can navigate our way through a complex environment.