The FDA released two new documents aimed to clarify the process for clinical trial approval and establishing earlier clinical trial studies during device development. The FDA is currently searching for a small number of companies to in the pilot program. Jeffery...
A group of bipartisan senators introduced a plan to streamline the FDA’s regulation that would speed up the process of taking innovations to the market and encourage innovation. The bill would also focus on restoring balance to the conflict of interest...
The FDA is working on developing a quality-by-design (QbD) model for clinical trials that would cut monitoring costs. The plan is to implement the model within the next 25 years. There is already a QbD model is place for manufacturing that allows for the quality...
Today, we announced some very exciting news. Pearl IRB has grown. To meet the needs of our clients, we have expanded our service offerings. Pearl Pathways, the new parent company, will be organized into three distinct and efficient business units. Pearl IRB remains...
Health and Human Services announced in July a proposal to improve rules protecting human research. The proposed changes can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects...
