FDA Launches New Webpage for CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products for COVID-19

To promote public confidence in FDA’s scientific review process and in ultimately appropriately using products authorized for emergency use, CDER launched a new webpage to disclose information from our scientific review documents supporting Emergency Use Authorizations (EUA) for drug and biological therapeutic products.

This new webpage compiles all the scientific review documents supporting EUAs for COVID-19 drug and biological therapeutic products into one location to make documents easier to find.

Under the EUA, fact sheets that provide important information about using bamlanivimab and etesevimab administered together in treating COVID-19 as authorized must be made available to health care providers and to patients and caregivers. These fact sheets include dosing instructions, potential side effects and drug interactions. Serious and unexpected adverse events including hypersensitivity, anaphylaxis, and infusion-related reactions have been observed with bamlanivimab with and without coadministration of etesevimab. In addition, clinical worsening following bamlanivimab administration has been reported, although it is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Possible side effects of bamlanivimab and etesevimab administered together include nausea, dizziness, pruritus, and rash. 

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FDA Launches New Webpage for CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products for COVID-19

To promote public confidence in FDA’s scientific review process and in ultimately appropriately using products authorized for emergency use, CDER launched a new webpage to disclose information from our scientific review documents supporting Emergency Use Authorizations (EUA) for drug and biological therapeutic products.

This new webpage compiles all the scientific review documents supporting EUAs for COVID-19 drug and biological therapeutic products into one location to make documents easier to find.

Under the EUA, fact sheets that provide important information about using bamlanivimab and etesevimab administered together in treating COVID-19 as authorized must be made available to health care providers and to patients and caregivers. These fact sheets include dosing instructions, potential side effects and drug interactions. Serious and unexpected adverse events including hypersensitivity, anaphylaxis, and infusion-related reactions have been observed with bamlanivimab with and without coadministration of etesevimab. In addition, clinical worsening following bamlanivimab administration has been reported, although it is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Possible side effects of bamlanivimab and etesevimab administered together include nausea, dizziness, pruritus, and rash. 

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