On May 11, 2020, the FDA issued two new guidances for industry and investigators of drugs and biological products proposed for use against COVID-19. These two guidances, "COVID-19 Public Health Emergency: General Considerations for Pre-IND Meetings Requests for COVID-19 Related Drugs and Biological Products" and "COVID-19: Developing Drugs and Biological Products for Treatment of Prevention," provide insight into the expectations of the FDA regarding new treatment drug development programs in the fight against COVID-19.
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Originally published June 2, 2020
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.
