The U.S. FDA’s response to the COVID-19 pandemic may have got off to a rocky start, but the agency’s device center has changed course rather quickly several times in recent months. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the latest COVID-19 town hall that the push…
The ongoing coronavirus disease 2019 (COVID-19) pandemic has magnified the value of real-world data (RWD) in oncology. The FDA is presently spearheading several initiatives aimed at refining the role of RWD in cancer care to guide clinical trial development, procure answers to pressing clinical questions, and support regulatory decisions for in vitro diagnostics, according to…
Janet Woodcock, one of the FDA’s most powerful regulators, has an almost mythic reputation and an outsized personality to match. For years, rumors have swirled: Who could possibly succeed her? Now, it seems, there’s an answer to that question: The FDA official who has been tapped to step into Woodcock’s role for at least…
The US Food and Drug Administration (FDA) is collaborating with the Reagan-Udall Foundation and Friends of Cancer Research for a project called Covid-19 Diagnostics Evidence Accelerator. The project aims to enhance the development of coronavirus diagnostics. It will enable experts in health data to analyse diagnostic and clinical data in real-time and analyse what…
To take an additional step toward harnessing real-world data to help inform the agency’s overall response to the covid-19 public health emergency, FDA has announced its participation in the Covid-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics. The Diagnostics Evidence Accelerator is organized by the Reagan-Udall Foundation for FDA…
The US Food and Drug Administration’s recent tissue-agnostic approval of pembrolizumab (Merck’s Keytruda) using tumor mutational burden as a predictive biomarker has sparked debate among oncologists on whether the agency made the right decision and whether the availability of another pan-cancer indication is in the best interest of patients. The FDA last week granted…
Even as he coronavirus disease 2019 has reached global pandemic levels, the time is right to encourage community oncology practices to expand their offerings by enabling clinical trial enrollment for their patients. “We’ve seen an expansion of telehealth capabilities and acceptance,” Howard “Skip” Burris III, MD said during the 2020 Community Oncology Conference, held…
Foundation Medicine struck a huge blow for the advancement of biomarker-driven cancer treatments last week. The Cambridge, MA-based company won approval from FDA for FoundationOne CDx to work as a companion diagnostic that would work alongside Merck’s KEYTRUDA (pembrolizumab), an anti-PD-1 therapy. KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of…
FDA is participating in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics. The accelerator is organized by the Reagan-Udall Foundation for FDA in collaboration with Friends of Cancer Research. “While there are current studies of viral diagnostic and antibody tests using traditional assessment methods, the Diagnostics Evidence…
Real-world evidence covers clinical insights on potential benefits or risks of a medical product taken from real-world data — information derived from registries, electronic health records, claims and billing data, as well as mobile devices and other sources that reflect patients’ actual use of products. The need to better harness and consider those insights…
