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…
In nearly 7,000 public comments submitted in response to the US Food and Drug Administration’s proposal to oversee laboratory-developed tests, laboratories and providers across a wide spectrum of the healthcare market strongly oppose the agency’s plans. The comments also, however, indicate different medical specialties may take different views of the FDA proposal, with oncologists and…
Roy S. Herbst, deputy director of Yale Cancer Center and Smilow Cancer Hospital and assistant dean for translational research at Yale School of Medicine, was elected to the Friends of Cancer Research Board of Directors. Herbst is an expert in lung cancer treatment and research. His research is focused on developmental therapeutics and the personalized…
Heading into 2024, as with any annual flip of the calendar, we anticipate there will be things that will fade away, things that will persist, and things that will develop — in the clinical research industry as in life. And so, when Clinical Leader asked experts across the continuum about their thoughts for the new…
At a recent annual meeting, Friends of Cancer Research released three white papers based on discussions between FDA, NCI, industry, and academia: Interpreting data from dose-finding studies in early phase oncology trials to determine the optimal dose Incorporating pragmatic elements in study designs to enhance oncology randomized clinical trials Maximizing data from academic-led studies for…
