What: The Reagan-Udall Foundation for the FDA (FDA Foundation), in collaboration with the U.S. Food and Drug Administration, is hosting a virtual public meeting to explore questions about access to naloxone, a drug used to reverse opioid overdoses. Harm reduction specialists, physicians, pharmacists, and regulators will share their experiences in addressing the availability of this life-saving medication for heroin, fentanyl, and prescription opioid overdose. Significant time is set aside to allow public comment for up to 30 people (pre-registration required).

The U.S. Food and Drug Administration will host a virtual public workshop on Mar. 29, to discuss critical questions around access to naloxone, a drug used to reverse opioid overdoses. The workshop is a collaboration with the Reagan-Udall Foundation for the FDA.

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.