Search Results for keywords:"Emergency Use Authorization"

The Food and Drug Administration (FDA) has issued five Emergency Use Authorizations (EUAs) for drugs and biological products during the COVID-19 pandemic. These authorizations, allowed under the Federal Food, Drug, and Cosmetic Act, aim to help address public health emergencies by making medical products available when there are no adequate alternatives. The products authorized include those requested by Baxter Healthcare, the U.S. Department of Health and Human Services, Eli Lilly and Company, and Regeneron Pharmaceuticals. The FDA ensures that these authorizations are based on scientific evidence indicating that the benefits of using these products outweigh the risks.

The Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUAs) for biological products during the COVID-19 pandemic, one requested by Pfizer, Inc., and the other by ModernaTX, Inc. These Authorizations allow the use of vaccines to help manage the public health emergency declared by the Secretary of Health and Human Services. The Authorizations include specific conditions and are part of efforts to protect public health and national security in response to the SARS-CoV-2 virus, which causes COVID-19. The FDA ensures that such products can be used when there are no adequate, approved alternatives available.

The Food and Drug Administration (FDA) has announced a public meeting of the Vaccines and Related Biological Products Advisory Committee on February 26, 2021. The purpose of the meeting is to discuss the emergency use authorization (EUA) request by Janssen Biotech Inc. for their COVID-19 vaccine. The meeting will be held online due to the COVID-19 pandemic, and the public is invited to provide comments by February 25, 2021. FDA will make the meeting's background material available online at least 2 days before the meeting.

The Food and Drug Administration (FDA) has announced the revocation of the Emergency Use Authorization granted to B. Braun Medical, Inc. This authorization was for the Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES, which were initially approved for emergency use during the COVID-19 pandemic. The revocation, effective October 1, 2024, follows a request from B. Braun Medical, Inc., due to a lack of customer demand and the improved COVID-19 situation. This decision ensures public health and safety is maintained.