Register for the 2018 Clinical Performance Metrics & Analytics Summit. Todd Johnson, Principal Consultant at Halloran Consulting Group, is a panelist. Use code HALLVIP for 15% off of your registration.
A successful Initial Targeted Engagement for Regulatory Advice on CBER products (INTERACT) meeting with CBER paved the way for the early product manufacturing activities and very early preclinical safety and efficacy evaluations. A pre-Investigational New Drug (Pre-IND) meeting provided additional clarity on the IND-enabling activities needed to support an initial IND submission in support of a Phase 1 first-in-human (FIH) study.
In September, the U.S. Food and Drug Administration (FDA) approved the Apple Watch’s electrocardiogram feature, clearing the way for use of the watch as a medical device. This is the latest step in the FDA trying to quickly catch up with the evolution of technology available to consumers going the direction of medical devices.