(Total Views: 1298)
Posted On: 03/22/2021 7:50:21 PM
Post# of 148902
Re: Rubraquercus #83964
I think "conditional EUA" for critical patients can be explained by the below:
https://www.fda.gov/regulatory-information/se...additional
4. Additional Conditions of Authorization
FDA, on a case-by-case basis and to the extent feasible given the circumstances of the emergency, may establish additional conditions that FDA finds to be necessary or appropriate to protect the public health (section 564(e))52, such as the following:
> Distribution and administration — conditions may be placed on which entities may distribute and who may administer the product, and how distribution and administration are to be performed. In addition, conditions may be placed on the categories of individuals to whom, and the circumstances under which, the product may be administered.
https://www.fda.gov/regulatory-information/se...additional
4. Additional Conditions of Authorization
FDA, on a case-by-case basis and to the extent feasible given the circumstances of the emergency, may establish additional conditions that FDA finds to be necessary or appropriate to protect the public health (section 564(e))52, such as the following:
> Distribution and administration — conditions may be placed on which entities may distribute and who may administer the product, and how distribution and administration are to be performed. In addition, conditions may be placed on the categories of individuals to whom, and the circumstances under which, the product may be administered.
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