In a world where medical advancements promise better health for all, the path to achieving this goal is fraught with challenges, not least of which is the issue of diversity in clinical trials. At a recent Friends of Cancer Research virtual meeting, Representative Anna Eshoo (D-CA) spotlighted a critical shortfall in the pursuit of equitable…
The US Food and Drug Administration (FDA) is several weeks late in issuing guidance on how and when drug and device companies must submit diversity action plans for clinical trial research. The Food and Drug Omnibus Reform Act (FDORA), passed by Congress in late December 2022, requires drug and device manufacturers to submit diversity action plans to…
Rep. Anna Eshoo (D-CA) called out the FDA for having yet to publish guidance for industry on drafting diversity action plans for clinical trials during a Friends of Cancer Research virtual meeting Thursday. In opening remarks, Eshoo, who chairs the House Energy and Commerce health subcommittee and is retiring at the end of this term,…
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,…
