On February 2, the American Cancer Society Cancer Action Network (ACS CAN) was joined by 20 other organizations in proposing the Health and Human Services Office of Inspector General adopt a new regulatory safe harbor from the Anti-kickback Statute that would allow clinical trial sponsors to financially support patients to offset indirect or non-medical costs…
Friends of Cancer Research initiated a new research partnership, Digital and Computational Pathology Tool Harmonization, or Digital PATH, Project. The project will identify factors that may contribute to variability in biomarker assessment across computational pathology platforms, propose areas for alignment in the field, and provide insights for shaping regulatory processes. The Digital PATH Project is…
As artificial intelligence becomes an indispensable tool in cancer research, drug sponsors and researchers should focus on building and utilizing rich real-world evidence databases that can be used to complement clinical trials. “We have blood markers now. We have tissue markers,” said Roy Herbst, deputy director of Yale Cancer Center and Smilow Cancer Hospital, assistant…
Nonprofit advocacy group Friends of Cancer Research held a meeting last week on the future of oncology and other diagnostic tests, reporting progress in some of its assay harmonization programs but highlighting struggles faced by other proposed programs in an evolving and uncertain regulatory landscape. The nonprofit hosted speakers from the US Food and Drug…
The US Food and Drug Administration under a “Trump 2.0” is unlikely to be given the same independence from White House oversight that it enjoyed during Donald Trump’s initial term as president, said Scott Gottlieb, Trump’s first FDA commissioner. “There was a little less adult supervision,” Gottlieb said of the Trump administration’s oversight of the…
The in vitro diagnostics (IVD) down-classification initiative A quick background on medical device regulation: In vitro diagnostics (IVDs) are regulated by the FDA as medical devices – meaning that tests and diagnostics typically go through the medical device market access pathways and comply with post-market regulations (e.g., quality system requirements). Under the purview of the FDA’s device…
The US Food and Drug Administration (FDA) intends to reclassify most high-risk in-vitro diagnostics (IVDs) from class III devices to class II moderate-risk devices. The agency says the move will ease the burden on IVD sponsors who can use the 510(k) premarket notification pathway instead of the more burdensome premarket approval (PMA) process. Jeff Shuren,…
Advocacy group Friends of Cancer Research on Thursday launched a research project focused on improving biomarker assessment across computational pathology platforms. The Digital and Computational Pathology Tool Harmonization (Digital PATH) Project aims to identify factors that may contribute to variability in biomarker assessment across computational pathology platforms, propose areas for alignment in the field, and…
One of the features that excites me about representing life sciences and other technology innovators is the impact they can have on our society. I enjoy using the skills I learned in over 30 years of working with business leaders at a global health products company to help those innovators navigate the pathway to the…
The story of Janet Woodcock’s illustrious career is not just one of professional achievements; it’s a tale of enduring partnerships, empathetic leadership, and unwavering commitment to science and patient care that will continue as she leaves public service this year. My 25-year friendship with Janet began at a time when skepticism about the FDA’s role…
