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U.S. FDA

@US_FDA

19 Oct

In our ongoing response to the #COVID19 pandemic, here’s an update on some of the actions we’ve taken. fda.gov/news-events/pr…

On Oct. 12, we approved an abbreviated new drug application for propofol injectable emulsion, single patient-use vials. accessdata.fda.gov/scripts/cder/o…

We updated the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kits recall classification notice & letter to health care providers to clarify that the potential for false positive results is due to the software associated with the kits. fda.gov/medical-device…

Read 4 tweets

U.S. FDA

@US_FDA

23 Aug

Today, FDA approved the first COVID-19 vaccine for the prevention of #COVID19 disease in individuals 16 years of age and older. fda.gov/news-events/pr…

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.

@DrWoodcockFDA

“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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U.S. FDA

@US_FDA

20 Aug

Here’s an update on some of the actions we’ve taken this week in our ongoing response to the #COVID19 pandemic. fda.gov/news-events/pr…

We issued a warning letter jointly with the Federal Trade Commission to Mahita, LLC dba PushMyCart for selling unapproved products with unproven COVID-19 claims. fda.gov/inspections-co…

On August 13, the FDA held a stakeholder call in recognition of National Immunization Awareness Month to discuss vaccines for younger children and adolescents in preparation for the school year.

Read 4 tweets

U.S. FDA

@US_FDA

11 Jun

FDA announcing today that it is authorizing for use, under the emergency use authorization (EUA) for the Janssen #COVID19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. fda.gov/news-events/pr…

While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.

The FDA’s decision to include these two batches of vaccine drug substance in the EUA for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the U.S. or exported to other countries.

Read 6 tweets

U.S. FDA

@US_FDA

8 Jun

Here is today's update on some of the actions we’ve taken recently in our ongoing response to the #COVID19 pandemic. fda.gov/news-events/pr…

@WhiteHouse

We contributed to a series of policy recommendations to address the vulnerabilities in U.S. pharmaceutical supply chains during emergencies like #COVID19. These recommendations were part of a report that was published by @WhiteHouse today. fda.gov/about-fda/repo…

@FTC

We issued joint warning letters with @FTC to Beauty & Spa Concepts, DBA Beenefits and to Everything Health LLC for selling unapproved products with unproven #COVID19 claims. fda.gov/inspections-co…

Read 6 tweets

U.S. FDA

@US_FDA

18 May

Here is today's update on some of the actions we’ve taken in our ongoing response to the #COVID19 pandemic. fda.gov/news-events/pr…

https://twitter.com/FDA_Drug_Info/status/1394375036551712773

We provided info about the status of the monoclonal antibody investigational drug, leronlimab, for the treatment of #COVID19. The data from CytoDyn, Inc.’s recent clinical trials do not support the clinical benefit of leronlimab for COVID-19 treatment.

https://twitter.com/FDA_Drug_Info/status/1394375036551712773

We updated the Johnson & Johnson #COVID19 vaccine fact sheet for recipients and caregivers to be available in multiple languages. fda.gov/emergency-prep…

Read 4 tweets

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