If the proposed Advanced Research Projects Agency for Health is created, new treatment candidates would need to engage with FDA early on to help determine appropriate clinical testing design, FDA principal deputy commissioner Janet Woodcock said Monday at the Reagan Udall Foundation for the FDA’s annual public board of directors meeting. Read more here.
Global Genes, a leading rare disease patient advocacy organization, today announced its 7th annual
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 that work and allowed the agency to streamline much of its activities at a critical moment in time, according to FDA Commissioner Robert Califf.
Strategies to expand access to naloxone (Narcan) for the prevention of opioid overdoses were explored during a webinar hosted by the Reagan-Udall Foundation for the FDA on Tuesday.
Over 100,000 people died from drug overdoses over a 12-month period ending in April 2021, according to CDC's provisional data.
FDA and the Reagan-Udall Foundation will hold a virtual meeting on March 29 to discuss strategies to increase access to naloxone, the opioid overdose reversal drug.
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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.
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