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Covid-19 Molecular Diagnostic Testing — Lessons Learned - The New England Journal of Medicine
On February 4, 2020, the U.S. secretary of health and human services declared that emergency use of diagnostics for SARS-CoV-2 was justified, triggering emergency authority for the Food and Drug Administration (FDA) to grant an emergency use authorization (EUA) for a device if it reasonably believes that it may be effective, rather than waiting to grant full approval when it has reasonable assurance that the device is safe and effective.
Ask the Accelerators: Dr. Nirosha Lederer on COVID-19’s implications for the future of RWE, and what we’ve learned so far - Aetion
Dr. Nirosha Lederer discusses COVID-19’s impact on the future of real-world evidence (RWE), key learnings, and evolving regulatory perspectives in this Aetion 'Ask the Accelerators' interview.
UPDATED: Aetion pushes Series B to $82M as pandemic puts real-world evidence under the spotlight - Endpoints News
Former FDA chief Scott Gottlieb’s favorite real-world evidence platform is getting a new stream of cash, as it nears what will likely be the biggest test of the young company so far.
Aetion, the New York health tech startup, has for the second time raised an extension to their Series B, adding $19 million from J&J’s VC arm, Greenspring Associates and EDBI to bring their round to $82 million. Gottlieb, who championed real-world evidence as commissioner and later joined the company’s board, said in a statement that the new cash would help fuel a global expansion.
COVID-19 Hub
Learn more about COVID-19 clinical trials and expanded access opportunities