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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Today, the FDA issued and immediately implemented a new guidance entitled, “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.”

#DYK women report more pain than men and experience pain differently? It’s true. To ensure your safety, prescription pain medicines should always be used as directed to avoid serious injury or even death. Learn more from @FDAWomen :

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Every woman is different. That’s why no one birth control option is right for everyone. Explore your options and talk to your healthcare provider about what birth control method is best for you Learn more from @FDAWomen :

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Federal court enters consent decree against Washington state juice processor, Valley Processing, Inc. to cease juice processing activities after FDA investigation disclosed insanitary conditions and failure to adhere to relevant food safety standards.

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In our latest #FDAVoices  find out about FDA’s new collaboration with @usnistgov  to increase U.S. medical supply chain resilience and advance domestic manufacturing of pharmaceuticals, biopharmaceuticals, and medical devices.

Here is a look at some of the actions the FDA took this week in response to the #COVID19  pandemic.

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On January 13, the FDA issued a temporary guidance entitled, “COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity.”

As of today, 317 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 236 molecular tests and sample collection devices, 68 antibody tests, and 13 antigen tests.

Knowledge is power! @FDAWomen  has FREE resources to help you make the most informed decisions about your health.

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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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"A 35 percent improvement in survival is a pretty substantial clinical benefit," FDA Commissioner@SGottliebFDA  said in relation to the convalescent plasma emergency use authorization issued today.

RECALL ALERT: Tanimura & Antle is recalling packaged single head romaine lettuce with 10/15 or 10/16 pack dates due to possible E. coli contamination. Consumers shouldn’t eat affected product. We’re actively investigating & will provide more information.

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FDA is requesting immediate removal of all Rx and over-the-counter ranitidine (Zantac) from the U.S. market.

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Today, we issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of hospitalized COVID-19 patients as part of the agency’s ongoing efforts to fight #COVID19 .

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Today, we issued an emergency use authorization (EUA) for the first #COVID19  diagnostic test that allows for self-collection & testing at home and provides test results in 30 minutes or less. The test kit for home use is available by prescription only.

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Today, the FDA issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for #COVID19 . The Ellume COVID-19 Home Test is authorized for people 2 years old and up, including those not showing symptoms.

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FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr.

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