Blog
Ethics of an NIH blood transfusion study under scrutiny
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...
Pearl IRB becomes a SMART IRB participating institution
Pearl IRB is pleased to announce that we have joined SMART IRB, a platform to ease common challenges and burdens associated with initiating multisite research. SMART IRB is a collaborative initiative supported by the National Center for Advancing...
Will MEDDEV 2.7/1 Rev 4 updates lead to staffing issues for medical device manufacturers?
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,...
Pearl IRB announces HBA Indiana Chapter sponsorship
We are excited to announce our sponsorship of the Healthcare Businesswomen’s Association- Indiana Chapter. HBA is a global nonprofit organization comprised of individuals and organizations across the healthcare industry. The core purpose of HBA is to...
FDA: remaining proposed and final rules for 2017
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...