While the US Food and Drug Administration (FDA) began the process of modernizing its IT systems before the COVID-19 pandemic, the crisis accelerated much of that work and allowed the agency to streamline much of its activities at a critical moment in time, according to FDA Commissioner Robert Califf. On 31 March, FDA published its Modernization…
Real-world data (RWD) potentially could be used to supplement data from clinical screening studies to support regulatory decision making for multi-cancer early detection (MCED) screening tests, according to a new white paper from the Friends of Cancer Research. MCED tests are an emerging technology that uses a sample of blood, also called a liquid biopsy,…
WASHINGTON — Health secretary Xavier Becerra is suddenly the target of a frenzied lobbying campaign aimed at ensuring the independence of ARPA-H, the new high-stakes research agency that President Biden has said will “end cancer as we know it.” But in a strange turn, many of the lobbyists are actually lawmakers. In recent days, Becerra…
The US Food and Drug Administration quietly unveiled yet another Oncology Center of Excellence “project.” This one, Project Protect, is aimed at providing “consistent advice and review” of safety signals across oncology drug classes. In what has become a familiar strategy for Director Rick Pazdur, OCE launched Project Protect without fanfare in 2021. OCE first…
Robert Califf will have to face several controversial health issues in his second tenure as commissioner. Susan Jaffe reports from Washington, DC. After 13 months and two COVID-19 surges, the US Food and Drug Administration (FDA) finally has a permanent commissioner: Robert Califf. A widely respected cardiologist and researcher, Califf returned for his second spell…
A House committee will spotlight an FDA process that’s been criticized as putting some of the costliest drugs on the market with limited evidence. The House Energy and Commerce Committee Health Subcommittee will tackle 22 pieces of legislation at a hearing on Thursday about the future of medicine. The hearing comes as the Congress considers legislation to…
The House Energy & Commerce committee’s health subcommittee on Thursday dug into almost two dozen different FDA- and pharma-related bills that may be tacked onto a larger bill or even the biopharma user fee bills, which have to be reauthorized before the end of September. The massive batch of bills making their way through the…
Legislation that would reform how diagnostic tests are regulated will be part of the FDA’s must-pass user fee bills, Sen. Patty Murray (D-Wash.) confirmed Tuesday, a move that could settle a longstanding debate about the agency’s authority over laboratory-developed tests. “Senator [Richard] Burr and I are working on a bipartisan policy to try and improve…
Ellen Sigal, the founder of the patient advocacy group Friends of Cancer Research (FOCR), is a self-described accidental tourist in the world of drug discovery. After completing a PhD in Russian History and launching a career as a real estate developer, the death of her 40-year-old sister from breast cancer forced her to confront medicine’s…
TN Tribune– The Reagan-Udall Foundation for the Food and Drug Administration (FDA Foundation) has elected four new Board members: David C. Fajgenbaum, MD, MBA, MSc, FCPP, University of Pennsylvania William N. Hait, MD, PhD, Johnson & Johnson James E.K. Hildreth, MD, PhD, Meharry Medical College Debra L. Ness, former President of the National Partnership for…
