A key focus for new National Institutes of Health (NIH) Director Monica Bertagnolli is spearheading innovative way to get more patients into in clinical trials to improve evidence generation, she said in recent remarks, including by getting providers more involved in trial enrollment. Her remarks are in line with calls by the non-profit Reagan-Udall Foundation…
What’s New? This week, Friends of Cancer Research (FOCR) hosted its 2023 annual meeting. The agenda featured three substantive sessions on topics FDA has been focused on for the past year: dose selection in early clinical studies, evaluating the use of oncology products in real-life versus in a controlled research setting, and how real-world data can be…
What’s New? Yesterday, Friends of Cancer Research (FOCR) hosted its 2023 annual meeting. The agenda featured three substantive sessions on topics FDA has been focused on for the past year including dose selection in early clinical studies, evaluating the use of oncology products in real-life versus in a controlled research setting, and how real-world data can be…
A US Food and Drug Administration advisory committee review of two Acrotech Biopharma LLC accelerated approval drugs with long-overdue confirmatory trial requirements may provide the clearest insight yet into how the Oncology Center of Excellence interprets the “due diligence” requirement for such studies and how sponsors’ planning and implementation strategies may factor into this determination. The Oncologic…
Oncology sponsors soon will better understand the meaning of “ongoing” in the context of a confirmatory trial and the potential barrier it presents to accelerated approval. OCE Director Richard Pazdur said 14 November that guidance on the meaning of “ongoing” is in development – and he also emphasized that without an ongoing confirmatory trial, an…
The Food and Drug Administration’s top cancer drug regulator doesn’t always ask for permission before taking on big initiatives. Richard Pazdur, director of the FDA Oncology Center of Excellence, hates bureaucracy. It stifles his ideas for getting treatments to cancer patients faster — of which there are many. To cut through that bureaucracy, Pazdur has…
The new leader of the NIH is worried about obesity. Monica Bertagnolli, who was confirmed as the new NIH director last week, said that during her first meeting with the NIH institute heads, she posed a question: “Is there anybody in this room who isn’t worried about obesity?” “The answer is really no,” she told the…
The new National Institutes of Health director, Monica Bertagnolli, said it’s a “failure” that enrollment in government-funded clinical trials has lagged behind those funded by the pharmaceutical industry. “If you just look at the number of patients who go on government-funded trials, it’s been completely flat over the last decade,” she said at a meeting…
The nonprofit Reagan-Udall Foundation that advises the FDA is recommending the agency lead an inter-agency and industry task force to streamline and strengthen post-approval studies of drugs and devices. For a variety of reasons, many post-approval studies are never completed or take years longer than expected and FDA Commissioner Robert Califf said Tuesday that data…
Longtime cancer doctor Monica Bertagnolli is finally heading to the National Institutes of Health director’s office after a nearly two-year effort to install a permanent leader atop the $48 billion science agency. The Senate voted 62-36 Tuesday to confirm her nomination, giving the White House clearance to officially name Bertagnolli the institute’s director, the second…
