Coverage

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…
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…
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…
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.…
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.
The Reagan-Udall Foundation for the FDA published a report today that looks into the lessons learned about the clinical evaluation of therapeutics for COVID-19. The 21-page report is based on discussions from a workshop last September. …
Just 10 months since administration of the first COVID-19 vaccine dose, hundreds of millions of people worldwide have been inoculated. As of mid-August, more than 4 billion vaccine doses have been administered worldwide, and over 50%…
WASHINGTON, Sept. 28, 2021 /PRNewswire/ -- The Reagan-Udall Foundation for the FDA will present 2021 Innovations in Regulatory Science Awards to Peter Marks, MD, PhD, The COVID-19 Research Database, and former U.S.…
The U.S. government should consider creating a strategic national stockpile of capacity for clinical research. Government could also fund and help create a standing network of clinical trial sites that can immediately respond to future pandemics — and…
Sponsored by Reagan-Udall Foundation, key federal leadership and important stakeholders join a virtual public workshop on September 28 titled  “Federal COVID-19 Response: Clinical Evaluation of Therapeutics Lessons Learned.”  The event will…