US Food and Drug Administration officials appear to want stakeholders, and maybe more importantly, lawmakers, to let go of the notion that failure is not an option with accelerated approval.

“There is going to be uncertainty regarding whether the drug will actually impact a clinical outcome at the time of approval,” Jacqueline Corrigan-Curay, FDA Center for Drug Evaluation and Research principal deputy center director, said during an 11 March Reagan-Udall Foundation webinar on the expedited pathway. “Uncertainty by definition means that not every study will confirm benefit.”

Two organizations with roots at MIT have joined forces to improve our understanding and use of rapid antigen tests in real-world settings. IDx20, headed by MIT scientist Irene Bosch, together with the Chelsea Project are the recipients of one of only two national research grants totaling $1.8 million from the Reagan-Udall Foundation for the FDA (FDA Foundati

The Reagan-Udall Foundation for the Food and Drug Administration (FDA Foundation) has appointed 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 and Debra L. Ness, former President of the National Partnership for Women and Families. 

The full article is available here.

(March 7, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) has appointed four new members to our Board of Directors: 

Congress is dramatically increasing the amount of money that the NIH and FDA spend on research partnerships with the private sector — namely, collaborations with drug and device companies.

(March 1, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) awarded $1.8 million in funding for two research projects evaluating the Real-World Performance of In Vitro Diagnostics (PIVD). Beth Israel Deaconess Medical Center will receive $898,045 to study antigen and molecular COVID-19 tests using real-world patient data. IDx20 will receive $893,500 to compare the performance of COVID-19 antigen tests in clinical settings versus real-world data collection. Their project includes a coalition of teams from the City of Chelsea, MA.