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Re: Nanotoday post# 144743

Thursday, 09/17/2020 11:53:34 AM

Thursday, September 17, 2020 11:53:34 AM

Post# of 146291
Another way the FDA is accelerating the process for Covid is CTAP.

I don't think there is any doubt that FDA is accelerating things for Covid.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-accelerate-development-novel-therapies-covid-19


Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19

“As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies.

There are a large number of companies and researchers developing and evaluating COVID-19 related therapies. Given the urgent nature of the pandemic, under the FDA’s accelerator program, 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. As part of this work, the FDA is triaging requests from developers and scientists seeking to develop new drug and biologic therapies, getting the relevant FDA staff in touch with them and providing rapid, interactive input to get studies underway quickly. For example, the FDA has reviewed study protocols within 24 hours in many cases and has reviewed single-patient expanded access requests generally within three hours. The FDA is also collaborating with federal partners, developers and researchers to create protocols that can be used across institutions and programs to streamline efforts.



I'm sure one could always argue the opposite though, depending on one's viewpoint and positioning.

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