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.
https://seekingalpha.com/news/3556988-fda-rallies-troops-to-accelerate-development-of-covidminus-19-treatments
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.