According to MedPage Today, Public Citizen is calling for the immediate suspension of a large National Institutes of Health (NIH) sponsored trial comparing blood transfusion strategies after heart attacks. The consumer advocacy group said that the Myocardial Ischemia...
To date, manufacturers have had three choices when completing a clinical evaluation report (CER): 1) performing a clinical study, 2) performing a clinical literature review, or 3) a combination of performing a clinical study and literature review. However, with the...
According to an updated list of Department of Health and Human Services rulemakings, the US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017. Proposed Rulemakings Among the proposals coming are...
Last Thursday, an article was published in the New England Journal of Medicine in which former director of the US Centers for Disease Control and Prevention Thomas Frieden called for greater use of alternative data sources, other than randomized controlled trials...
According to a recent article on the Washington Post, more than 60% of cancer patients are older adults and that number could increase to 70% by 2040. However, seniors are rarely involved with clinical trials, leading to uncertainty with how treatments will affect...
The European Medicine Agency’s new guideline focuses on a sponsor’s responsibility to define the uncertainty associated with the medicines tested in clinical trials. The announcement occurred last week and the EMA guideline will go into effect on January 2nd of 2018....
