In The News
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,
BioSpace – FDA Commissioner Califf and the Potential of RWE in Clinical Trials
When Robert Califf became the new commissioner of the U.S. Food & Drug Administration, he did so with a plan to emphasize the use of real-world
Pink Sheet – US Patient-Focused Drug Development Meetings Changing With The Times
As the US Food and Drug Administration’s patient-focused drug development initiative hits the 10-year mark, stakeholders are eyeing ways the program has evolved and additional
Regulatory Focus – FOCR calls for flexibility in review of companion diagnostics for rare biomarkers
Friends of Cancer Research (FOCR) has issued a white paper calling on the U.S. Food and Drug Administration (FDA) to exercise greater regulatory flexibility in
