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Tuesday, March 31, 2020

FDA rallies troops to accelerate development of COVID-19 treatments

The FDA announces its Coronavirus Treatment Acceleration Program that, it says, leverages every tool at its disposal (e.g., cutting red tape, redeploying staff) to speed up the development of therapies to treat COVID-19 infection. Key points:
Staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are providing regulatory advice, guidance and technical assistance as quickly as possible, including triaging with developers and scientists to speed up the process. Examples of the new normal include reviewing study protocols within 24 hours and single-patient expanded access requests within three hours.
Medical and regulatory staff redeployed to serve on COVID-19 review teams.
Streamlined processes and operations for developers and scientists and additional resources for healthcare providers and researchers to help them file emergency requests for investigational products.
Advancing relationships with partners in the public and private sectors to rapidly collect and analyze information in areas like illness patterns and treatment outcomes.
ETFs: THW, BME, GRX, IXJ, GDNA, KMED, XLV
https://seekingalpha.com/news/3556988-fda-rallies-troops-to-accelerate-development-of-covidminus-19-treatments

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