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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
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… Image
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…
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
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…
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.
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
10 May
The FDA’s Center for Biologics Evaluation and Research @FDACBER will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 10, 2021, via webcast. fda.gov/news-events/pr…
During the meeting the agency will provide a status update on our approach to emergency use authorization (EUA) for #COVID19 vaccines intended for use in individuals 12 through 17 years of age.
The committee will also discuss the data needed to support an EUA and a biologics license application (BLA) for a #COVID19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products.
Read 4 tweets
13 Apr
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.
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
Treatment of this specific type of blood clot is different from the treatment that might typically be administered.
Read 7 tweets
2 Mar
In our ongoing response to the #COVID19 pandemic, we’ve taken several actions. Here’s our update: fda.gov/news-events/pr… Image
We’ve updated our FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA's response efforts. fda.gov/media/137005/d…
The FDA issued an Emergency Use Authorization (EUA) to Quidel for its QuickVue At-Home #COVID19 Test for at-home use with a prescription.
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27 Feb
Today, FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of #COVID19 caused by SARS-CoV-2. The EUA allows the vaccine to be distributed in the U.S for use in individuals 18 years and older. fda.gov/news-events/pr… Image
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for #COVID19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States.” – Acting FDA Commissioner @DrWoodcockFDA
The FDA has determined that the #COVID19 vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence it may be effective in preventing #COVID19.
Read 5 tweets
19 Dec 20
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. fda.gov/news-events/pr…
“With the availability of two vaccines now for the prevention of #COVID19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day.” – FDA Commissioner @SteveFDA
The FDA has determined that the #COVID19 vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence it may be effective in preventing #COVID19.
Read 5 tweets
18 Dec 20
Today, FDA’s Vaccines & Related Biological Products Advisory Committee met to discuss a request by ModernaTX, Inc. for emergency use authorization (EUA) for a vaccine for #COVID19 prevention. A final decision will be made by FDA’s career officials. fda.gov/advisory-commi…
Also today, we posted a new webpage: Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions. Questions cover specifics, such as what data did the FDA use to make the decision to authorize the vaccine for emergency use, to more general questions. fda.gov/emergency-prep…
Read 5 tweets
17 Dec 20
FDA has taken more steps to help combat #COVID19 and to protect public health. Here’s a look at some of our latest activities. fda.gov/news-events/pr… Image
We issued a new EUA for BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The test is authorized for use in patients age 4+ who are suspected of COVID-19 by their healthcare provider & are within the first 7 days of symptom onset. fda.gov/news-events/pr…
Yesterday, we issued an EUA for the first OTC, at-home, rapid diagnostic test for #COVID19. The Ellume COVID-19 Home Test is authorized for people age 2+ with or without symptoms. It can be used completely at home without a prescription. fda.gov/news-events/pr…
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16 Dec 20
FDA is aware of reports of an anaphylactic reaction in a #COVID19 vaccine recipient. The agency will continue to work with CDC and Pfizer to better understand what occurred. fda.gov/covid19vaccines
FDA takes seriously reports of any adverse events and requires Pfizer and vaccination providers to report the following serious adverse events, among other things, to the Vaccine Adverse Event Reporting System.
Importantly, fact sheets that provide important information, including dosing instructions, & information about the benefits & risks of the Pfizer-BioNTech COVID-19 Vaccine, are required to be made available to vaccination providers and vaccine recipients. go.usa.gov/xAYge
Read 4 tweets
12 Dec 20
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. fda.gov/news-events/pr…
“The FDA’s authorization for emergency use of the first #COVID19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.” – FDA Commissioner @SteveFDA
The FDA has determined that the #COVID19 vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence it may be effective in preventing COVID-19.
Read 5 tweets
11 Dec 20
Here’s a look at our latest actions as we work to protect the public health and fight #COVID19. fda.gov/news-events/pr…
Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of outside scientific and public health experts from around the country, met to discuss the first request for emergency use authorization for a #COVID19 vaccine.
FDA issued an EUA to LabCorp for its Pixel COVID-19 Test Home Collection Kit for use with LabCorp’s COVID-19 RT-PCR Test for non-prescription use. The Pixel COVID-19 Test Home Collection Kit is the first COVID-19 direct-to-consumer test system.
Read 5 tweets
22 Oct 20
Today, we gave the first FDA approval for a #COVID19 treatment. The drug was approved for adults and children ages 12 and older for the treatment of #COVID19 requiring hospitalization. fda.gov/news-events/pr… Image
This approval does not include the entire population that had been authorized to use the drug under an Emergency Use Authorization (EUA). An approval is different from the standard used for an EUA.
While children younger than 12 are not covered in this approval, children under 12 weighing at least 3.5 kg (about 8 pounds) are covered in a revised EUA for the drug.
Read 5 tweets
20 Oct 20
Here’s a look at some of the FDA’s latest activities in our ongoing response to the #COVID19 pandemic. fda.gov/news-events/pr… Image
We posted a new #FDAInsight podcast with @AnandShahFDA, and Dr. Peter Marks, Director of @FDACBER, discussing the upcoming Vaccines and Related Biological Products Advisory Committee meeting on Oct. 22, 2020. fda.gov/news-events/fd…
In a new #FDAVoices, “FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines,” Dr. Peter Marks highlights the value of transparency.. fda.gov/news-events/fd…
Read 5 tweets
15 Aug 20
Today, we issued an emergency use authorization to @Yale for its SalivaDirect #COVID19 diagnostic test, which uses a new method of processing saliva samples. This is the 5th test FDA has authorized using saliva as a sample for testing. fda.gov/news-events/pr… Image
With this test, a saliva sample can be collected in any sterile container. The test doesn’t need a special swab or collection device, or a separate nucleic acid extraction step.
Being able to perform a test without extraction kits can increase testing capacity and reduce the strain on resources. Also, the test can be used more broadly with different combinations of commonly used reagents and instruments.
Read 4 tweets