Скачать с ютуб Unpacking the FDA's New Proposed Rule for Laboratory Developed Tests в хорошем качестве

Unpacking the FDA's New Proposed Rule for Laboratory Developed Tests

After years of discussion surrounding public confidence in the reliability of laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) has put forth its own proposal that would upend current regulations by granting the agency oversight of LDTs. If enacted, the proposed rule would phase out the current enforcement discretion approach for LDTs and instead reclassify these tests as in vitro diagnostic (IVD) devices subject to lengthy and potentially costly FDA pre-market reviews. Lighthouse Lab Services recently welcome attorney Gail H. Javitt of health law firm Hyman, Phelps, & McNamara, and “The FDA Law Blog”, to dive into the specifics of this proposal and how labs stand to be impacted. Although discussion surrounding this rule remains fluid as the FDA seeks additional input from labs and stakeholders, now is the time to ensure your lab understands how your ability to develop and offer LDTs could be affected. We review: -Intros (00:30) -Overview (4:12) -How did we get here? (5:50) -FDA & LDTs, timeline (10:48) -LDTs & Congress (11:36) -What is proposed? (12:47) -Questions surrounding the proposal (16:25) -Areas for challenge (22:46) -FDA seeking feedback (33:36) -What's next? (35:27) -Advocacy opportunities (36:55) -Q&A (42:50) #medicallaboratoeysciencevideos #medicallaboratory #labtesting #fda #foodanddrugadministration #LDT