Congratulations to Jithesh Veetil, PhD, awarded The CDRH Regulatory Science Excellence Award for for the External Evidence Methods (EEM) Framework Project. MDIC EEM Framework is a document intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. Informed by a number of public forums and a survey of medical device manufacturers, the document catalogs different sources of external data and some of the traditional and novel statistical methods (Frequentist and Bayesian) applicable to the design and analysis of a clinical study in which external data play a role. Join Dr. Veetil at the JSM 2022 Conference for “Advancing Regulatory Science for Medical Devices and Medical Software Through Collaboration”, August 10, 2022 at 10:30 AM.
August 8, 2022
