We notified Bubs Australia that the FDA is exercising enforcement discretion for the importation of certain infant formula products following the review of information provided pertaining to nutritional adequacy and safety.
This Friday edition of the “FDA Roundup” includes warning letters on CBD products, a shelf-life extension for a monoclonal antibody, a warning letter, and more!
On May 20, the FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use.
On May 19, the FDA issued a warning letter to Santhigram Kerala Ayurvedic Co. of U.S., Inc. for selling unapproved products with fraudulent claims to treat multiple diseases, including COVID-19.
As of today, 436 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 302 molecular tests and sample collection devices, 84 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test.
Today, FDA approved the first COVID-19 vaccine for the prevention of #COVID19 disease in individuals 16 years of age and older.
Today, FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of #COVID19 caused by SARS-CoV-2 in individuals 16 years of age and older. The emergency use authorization allows the vaccine to be distributed in the U.S.