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.
The world’s worst outbreak of Ebola has killed close to 1,100 people in West Africa and the disease could continue spreading for months, increasing pressure on researchers to accelerate the development of therapeutic interventions.
The architecture of the autistic brain is speckled with patches of abnormal neurons, according to research partially funded by the National Institute of Mental Health (NIMH), part of the National Institutes of Health. Recently published in the New England Journal of Medicine, the study suggests that brain irregularities in children with autism can be traced back to prenatal development .
Last month, the National Institutes of Health, 10 biopharmaceutical companies and several nonprofit organizations launched an unprecedented partnership to transform the current model for identifying and validating the most promising biological targets of disease for new diagnostics and drug development.