TODAY’S CLINICAL LAB/G2 INTELLIGENCE: SEPTEMBER 5, 1:00PM EASTERN
Sheila D. Walcoff, JD, is a nationally recognized FDA policy expert and regulatory strategist. She is CEO and founder of Goldbug Strategies, a boutique consultancy focused on helping LDT/IVDs, investors, pharma/CDx, and AI/digital health technologies develop FDA regulatory strategies, submissions, and
QMSR/ISO 13485 quality systems for CLIA laboratories transitioning to the FDA regulatory environment. Sheila’s 25+ years’ experience includes leading LDT/IVD regulatory submissions (including PCCPs), FDA associate commissioner, senior science & public health counselor to the US HHS Secretary, partner at a “BigLaw” firm, US congressional committee counsel, entrepreneur, and JD from Georgetown University Law Center.
There is significant concern about the US Food and Drug Administration's (FDA) 2024 final rule to regulate laboratory-developed tests (LDTs). Oncology labs that previously developed their own LDTs may now be unsure of how to proceed in terms of costs, filings, and data collection.
During this free webinar, attendees will:
- Learn how the final rule applies to oncology LDTs.
- Find out what the FDA's action means for precision medicine efforts in cancer diagnosis and treatment.
- Become familiar with upcoming timelines tied to the final rule.
More than 1,000 laboratory professionals registered for our prior LDT webinar. Don't miss your chance to get expert insight into how cancer labs can successfully prepare for upcoming changes from the FDA when it comes to LDT use.
