Unions representing federal government workers vowed legal action over major cuts to probationary staff across the government Friday (Feb. 13), including at HHS subagencies, though it’s still unclear precisely how many staff are affected at each subagency. The layoffs are expected to impact about 5,200 probationary employees across HHS, a source told Inside Health Policy, but…
At a recent meeting hosted by the Friends of Cancer Research, experts from industry talked through next steps for development of companion diagnostics for rare diseases, including in oncology. The ideas come as FDA’s diagnostics regulatory reforms face an uncertain future with the new administration and agency staffing changes. Introduction: FDA’s diagnostics regulatory reform and…
BostonGene Drives Innovation in Rare Cancers Through Cutting-Edge AI-powered Diagnostics and Collaborative Research BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, is proud to announce its contributions to a white paper with Friends of Cancer Research entitled “Innovative Validation and Regulatory Processes for Companion Diagnostic Tests for Rare Biomarkers or Indications.” The…
Key takeaways: FDA issued guidance on decentralized elements of clinical trials last fall. Investigators need to balance using decentralized elements and limiting data variability. The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to continue their research. The FDA provided recommendations to investigators during the pandemic about how to…
Dr. Sara Brenner, who has been FDA CDRH’s in vitro diagnostics chief medical officer, is serving as acting commissioner of the agency. That’s according to a recent update to the agency’s leadership profiles. The FDA, which has been under a communications freeze under the new Trump administration, did not immediately respond to MassDevice requests for…
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, President Donald Trump took office and wasted no time signing a slew of executive orders that significantly affect the…
Janet Woodcock, former director of the Center for Drug Evaluation and Research at FDA, and Paul T. Kim, principal of Kendall Square Policy Strategies LLC, were appointed to the board of directors at Friends of Cancer Research. Woodcock has been an advocate and ally for Friends for over 25 years. Most recently, Woodcock served as…
Fabrice Chouraqui will become CEO of Pharming Group N.V. (Euronext:PHARM) pending the approval of the company’s shareholders at a March 4 extraordinary meeting. Chouraqui, a CEO-partner of Flagship Pioneering, will succeed Sijmen de Vries if approved. Friends of Cancer Research appointed FDA veteran Janet Woodcock and attorney Paul Kim to its board. Woodcock was most…
As the new Congress and a new administration start up, the fate of FDA-issued regulations on laboratory-developed tests (LDTs) is one of many issues that health advocates and lobbyists will be watching closely. LDTs are — as the name implies — clinical tests developed by individual labs in doctors’ offices and hospitals to be used…
The FDA’s influential director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., will soon retire from the agency. The seven-year FDA veteran communicated the decision in an internal communication viewed by Fierce Pharma. Her last day will be Jan. 18. “Leaving CDER was an extremely difficult decision, but the time has come…
