The FDA’s Final Rule on LDTs: What You Need To Know скачать в хорошем качестве

The FDA’s Final Rule on LDTs: What You Need To Know

The FDA’s final published rule on laboratory-developed tests (LDTs) will result in new oversight that will dramatically shift how clinical laboratories can develop and offer LDTs going forward. In this recorded webinar, ARUP Chief Medical Officer and Senior Director of Governmental Affairs Jonathan Genzen, MD, PhD, and Chief Compliance Officer Jonathan Carr, JD, provide an overview of the requirements included in the final rule and how these requirements differ across certain settings and types of testing. The webinar concludes with a Q&A session in which they share their perspectives on questions submitted by registered attendees.