Post by FDA

Join FDA via livestream for a discussion on the plausible mechanism guidance and its applicability to both CDER and CBER products: CDER & CBER All Hands: https://lnkd.in/ew3uG4jF The program will include special guests Rebecca Ahrens-Nicklas, MD, PhD, University of Pennsylvania, Lindsey A. George, MD, University of Pennsylvania, Kiran Musunuru, MD, PhD, University of Pennsylvania, and Sonia Vallabh, PhD, Broad Institute of MIT and Harvard. We will also discuss an update on Baby KJ, whose personalized CRISPR-based gene-editing therapy for a severe urea cycle disorder inspired the Plausible Mechanism Framework, and share researcher experiences on IND clearance and the FDA approval process.