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…
Assays to measure homologous recombination deficiency (HRD) in ovarian cancer vary widely, underscoring the need for standardization, since inconsistent assay results can influence treatment decisions. Patients with high-grade serous ovarian cancer (HGSOC) with HRD tumors have better outcomes when treated with PARP inhibitor maintenance therapy. Nearly half of patients with HGSOC have HRD, and approximately…
NEW YORK – For clinical labs, 2024 will most likely be remembered as the year the US Food and Drug Administration finally made good on its decades-old promise — or threat, depending on your point of view — to regulate laboratory-developed tests (LDTs). Yet, even as labs prepare to comply with the first round of…
Incorporating pragmatic and decentralized elements into postapproval studies poses less data collection and reliability risk than the premarket setting and can help the sponsor learn more about a drug’s effect in clinical practice, even if the trial is not aimed at expanding the approved indication. Experts from the US Food and Drug Administration, academia, industry…
Clinical trial simulations and predictive modeling will be important for improving regulatory decisions about oncology drugs showing strong efficacy on early endpoints but with uncertain overall survival benefits. Panelists at the recent Friends of Cancer Research Annual Meeting discussed a new white paper on the use of interim overall survival data in oncology trials. The FOCR project…
