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Accelerated Approval Program Virtual Public Meeting
The Accelerated Approval Pathway was created by Congress to allow patients with a serious or life-threatening disease earlier access to a potentially important treatment. At this virtual public meeting we explored the insights and lessons learned in the 30 years since its inception.
This Week at FDA
COVID-19 Evidence Accelerator: Therapeutics/Vaccines Lab Meeting
02/17/2022 - 03:00 PM
During our February Therapeutics/Vaccines Lab Meeting we will hear from colleagues at WHO and Gavi, TriNetX, and Kaiser Permanente California discuss ongoing vaccine research. Nevine Zariffa will also join us to discuss what we see in RCTs vs. RWD studies.
This is our once-monthly COVID-19 Evidence Accelerator Therapeutics/Vaccines Lab Meeting. These meetings occur the third Thursday of every month at 3pm ET.
COVID-19 Evidence Accelerator: Diagnostics Lab Meeting
This is the once-monthly COVID-19 Evidence Accelerator Diagnostics Lab Meeting. These meetings occur the third Thursday of every month at 12 pm ET.
If you are interested in attending the meeting series please email us at evidenceaccelerator@reaganudall.org.
Reagan-Udall Foundation for the FDA Issues Paper on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics
(February 4, 2022) The Reagan-Udall Foundation for the FDA, at the request of the U.S. Food and Drug Administration, has released a report that outlines initial lessons learned from the federal government’s and research communities’ COVID-19 response and provides actionable recommendations to enhance the scope, prioritization, and communication of research activities within the context of a public health emergency. The report can be viewed here.