In The News
Regulatory Focus – FDA says IT modernization came at right time for COVID
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
Regulatory Focus – White paper: RWD can support multi-cancer early detection screening test submissions
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
Stat News – Lawmakers and a Pelosi aide turn lobbyist to push for new health agency’s independence
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
Pink Sheet – US FDA Project Protect Oncology Safety Program In Broad Use After Quiet Launch
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
The Lancet – Califf takes the helm at the US FDA, again
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
Bloomberg Government – HEALTH CARE BRIEFING: Panel Scrutinizes Quick FDA Drug Approvals
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
Endpoints News – Accelerated approval reforms take center stage at House hearing, but a way forward remains unclear
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
Bloomberg Law – FDA User Fee Bill to Include Diagnostics Changes, Murray Says
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,
Nature – Reflections on 10 years of the FDA’s breakthrough therapy designation
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.
TN Tribune – Dr. James E. K. Hildreth Joins FDA Foundation Board
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,
