FDA updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section that clarifies how the agency intends to prioritize review of EUA requests for the remainder of the COVID-19 public health emergency. As noted in the guidance, for the remainder of the current pandemic, the FDA may decline to review and process further EUA requests other than those for vaccines whose developers have already engaged with the agency as described in the agency’s guidance, “Emergency Use Authorization Vaccines to Prevent COVID-19.”
Guidance can be found at below link:
Emergency Use Authorization for Vaccines to Prevent COVID-19
