Drugs, Biologics Authorized Under an EUA Not Considered to Be Investigational
Individuals who have received one of the COVID-19 vaccines approved for emergency use by the FDA do not need to be excluded from participating in other clinical trials, the agency has said.
The statement clarifies the FDA’s policy preventing clinical trials from enrolling participants who have received another investigational product whose efficacy and safety have not been proven. During the COVID-19 pandemic, the agency will not consider drugs, biologics and devices with an Emergency Use Authorization (EUA) to be investigational.
To read the updated guidance, click here: https://bit.ly/39tUy3z.