Release Date: December 11, 2020

The Food and Drug Administration (FDA) has issued two Emergency Use Authorizations (EUAs) for biological products to combat the COVID-19 pandemic. The EUAs were granted to Pfizer, Inc., and ModernaTX, Inc., following their requests.

According to the FDA's announcement, the EUAs contain conditions for the emergency use of the authorized products. These conditions are outlined in the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is providing legal notice to the public and judicial notice to the courts regarding these authorizations.

The EUAs were issued under the FD&C Act, which allows the FDA to grant emergency use authorization for biological products during times of public health emergencies. This move aims to provide access to life-saving treatments and vaccines during the pandemic.

It is worth noting that the official version of the Federal Register, which is the official journal of the US government, is available on a different website. However, this prototype edition of the daily Federal Register provides an XML rendition of published Federal Register documents for informational purposes only.

The FDA's commitment to providing accurate and reliable information has led to the development of this 'Web 2.0' version of the daily Federal Register. This new format aims to establish the XML-based Federal Register as an official legal edition, once it is granted official status by the Administrative Committee of the Federal Register (ACFR).

The FDA encourages those seeking complete information about its publications and access to official documents to visit its website. The agency is working towards establishing a comprehensive online platform for accessing its official publications, pending official recognition from the ACFR.

In conclusion, the issuance of EUAs by the FDA marks an important milestone in the fight against COVID-19. These authorizations will provide access to life-saving treatments and vaccines, while also underscoring the importance of public health emergencies and the need for timely action in response to them.

Release date december 11 2020