The University of Oxford and the National Institutes of Health (NIH) are considering launching human challenge trials if enrollment requirements in standard COVID-19 studies can’t be met. Read More
Sites feeling overwhelmed by increasing administrative responsibilities lay more blame on sponsors’ shoulders than on additional compliance rules set by regulators. Read More
In response to a federal court ruling made in February, the National Institutes of Health (NIH) has issued new rules for data transparency that mandate clinical trial sponsors submit missing data for studies conducted between 2007 and 2017. Read More
Three top FDA officials, including Commissioner Stephen Hahn, last week shared with their medical peers the agency’s primary considerations when reviewing COVID-19 vaccine trials, reassuring them that these vaccine candidates would face the same level of scrutiny as all other FDA-approved products. Read More
As concerns mount over the FDA coming under undue pressure to approve a COVID-19 vaccine, FDA Commissioner Stephen Hahn said again yesterday that the agency won’t take any shortcuts. Read More
Three clinical research groups funded by the FDA will present their work on clinical outcome assessments (COA) and standardized endpoints at a virtual public meeting Aug. 28. Read More
