U.S. FDA

U.S. FDA


Here you'll find the latest US Food and Drug Administration news and information. Privacy Policy - http://www.fda.gov/privacy

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COMING UP: Join us for today’s Vaccines and Related Biological Products Advisory Committee meeting on J&J (Janssen) boosters as well as mixing & matching vaccines. The event starts at 8:30 a.m. ET and can be live streamed here:

Does this word scare you? Don't let it by buying into mammography myths. Schedule your appointment today! #NationalMammographyDay  #BreastCancerAwarenessMonth 

❓ If I had #COVID19 , do I need a vaccine? ✔️ YES 💉 #FDAVaccineFacts : Get vaccinated regardless of whether you already had COVID-19. Experts do not yet know how long you are protected from getting sick again after recovering from #COVID19 .

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#HispanicHeritageMonth may be coming to an end, but you should always remember that your best legacy is your health! Get the latest updates from #HHM21 

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FDA continues to take steps to strengthen the premarket review program for devices. We are committed to protecting the public health by ensuring patients have more timely access to safe, effective, and high-quality medical devices. #FDAVoices 

Have you put off mammograms and other preventive health screenings due to the pandemic? On #NationalMammographyDay , prioritize your health by scheduling your mammogram along with your overall wellness exam. Mammograms can help save lives.

In our ongoing response to the #COVID19  pandemic, here’s an update on some of the actions we’ve taken this week.

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We posted information about an assessment of the EUA process that the FDA’s CDRH implemented to help authorize #COVID19  tests during the public health emergency.

As of today, 418 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 292 molecular tests and sample collection devices, 89 antibody and other immune response tests and 37 antigen tests.

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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 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.

Today, FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of #COVID19  caused by SARS-CoV-2. The emergency use authorization allows the vaccine to be distributed in the U.S for use in individuals 18 years and older.

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As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare

Today, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of #COVID19  to include adolescents 12-15 years of age. FDA amended the EUA issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.

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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 

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