FDA issues final guidance on developing drugs for COVID-19 treatment and prevention
The US Food and Drug Administration (FDA) yesterday issued the final guidance COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.
The guidance provides updated recommendations that reflect the evolving scientific knowledge and the current state of the pandemic. This supersedes the final guidance of the same name initially issued on May 12, 2020 and reissued on February 22, 2021.
The agency explained that, although the COVID-19 public health emergency has expired, SARS-CoV-2 continues to circulate, and COVID-19 remains a serious health risk for some individuals. There is a need to ensure that sponsors are aware of FDA’s recommendations on the development of drugs and biological products for treatment and prevention of COVID-19.
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