·其他事项申请人无需在eSTAR中提供适应症说明页（FDA Form 3881）、上市前审查递交封面页（FDA Form ...
The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all serious adverse events* and medication errors potentially related to PEMGARDA within 7 calendar days from the healthcare provider’s awareness of the event, using FDA ...