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Naloxone Access: Answering Questions
Reagan-Udall Foundation for the FDA Awards $1.8 Million in Research Funding for Studies on the Real-World Performance of COVID-19 Tests
(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.
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.