U.S. FDA

U.S. FDA


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Bubs Australia plans to provide at least 1.25M cans of several varieties of its infant formula such as stage 1 and 2 cans of Bubs Organic Grass Fed, Bubs Supreme A2 Beta-Casein Protein and Bubs Easy-digest Goat Milk, that will make at least 27.5 million full-size, 8-oz bottles.

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.

Our around-the-clock work as part of the all-of-government efforts has already begun to improve supply and availability.

We expect that the measures we’re taking, and the potential for Abbott Nutrition’s Sturgis, Michigan, facility to safely resume production in the near-term, will mean more and more supply is on the way or on store shelves moving forward.

The FDA will continue to dedicate all available resources to help ensure that infant formula products remain available for use in the U.S. and will keep the public informed of progress updates.

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!

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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.

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Today, FDA approved the first COVID-19 vaccine for the prevention of #COVID19  disease in individuals 16 years of age and older.

You are not a horse. You are not a cow. Seriously, y'all. Stop it.

Today, we authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of #COVID19  to include children 5 through 11 years of age.

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Today FDA and @CDCgov  issued a statement regarding the Johnson & Johnson #COVID19  vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.

The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the #COVID19  pandemic.” – Acting FDA Commissioner@DrWoodcockFDA 

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.

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