FDA's Draft Guidances for Emergency Use LDTs Spark Mixed Reactions
Julie Ballard
Public comments to the FDA’s draft guidances proposing enforcement policies for LDTs with and without a 564 Declared Emergency reveal a mix of support and opposition
Julie Ballard
Julie Ballard, principal of Carrot Clinical, is an independent clinical laboratory consultant with 25+ years of experience in helping organizations build and maintain world-class CLIA-certified and CAP-accredited clinical laboratories.
She assists clients with building, scaling, and maintaining clinical laboratories, quality systems, and regulatory programs; attaining CLIA certification, CAP and COLA accreditation, and California and New York state licenses; and launching novel laboratory-developed tests (LDTs).
Ballard is a licensed California Clinical Laboratory Scientist (CLS). Prior to founding Carrot Clinical, she played prominent roles in establishing quality management systems, regulatory compliance programs, and laboratory operations at ViroLogic (now Monogram Biosciences), Genomic Health (now Exact Sciences), Guardant Health, GRAIL, and Seer.