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's accounts: US_FDA
Tracking Since: October 16, 2019
On April 7, we authorized an extension for the shelf life of the refrigerated Janssen #COVID19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. https://t.co/kDANwIcHYC
We also authorized two over-the-counter at-home #COVID19 antigen tests. https://t.co/r6kdNlDfvI QT @FDADeviceInfo: The @US_FDA continues to take steps to help expand the availability of appropriately accurate and reliable over-the… https://t.co/ACefhg6TOF)
Additionally, we issued the draft guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. https://t.co/j4tTTeoOit QT @FDADeviceInfo: Today, the @US_FDA issued the draft guidance Cybersecurity in Medical Devices: Quality System Considerations and Co… https://t.co/8gryegSwUR)
On April 6, as part of our effort to protect consumers, we issued a warning letter jointly with the @FTC to Sensory Cloud, Inc for selling unapproved products with unproven #COVID19 claims. https://t.co/iy0vaBQ6aL
As of today, 428 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 294 molecular tests and sample collection devices, 84 antibody and other immune response tests and 50 antigen tests.
Don't miss today’s “FDA Roundup” including updates on #COVID19 vaccines and tests, our newest draft guidance, and continued consumer protection efforts. https://t.co/ETOEpW93GY
#NMHM2022 https://t.co/ZmwVHPtN8h QT @FDAHealthEquity: How much do you know about Diabetes? Watch @FDAHealthEquity’s new “Diabetes 101” video to learn about risk factors,… https://t.co/18dKLFfnM1)
RT @USCPSC: #Recall: About 3.74 Million Bottles of Reckitt Airborne Gummies. Pressure build up in unopened bottles can cause th… https://t.co/Cxdii9LKTv
As of today, 421 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 291 molecular tests and sample collection devices, 85 antibody and other immune response tests and 45 antigen tests.
Lastly, we updated a safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Test in dark blue packaging is a product of ACON Biotech (Hangzhou) Co., Ltd. https://t.co/a371Bkuema
In an effort to protect consumers, we issued a joint warning letter with @FTC to Viraldine, LLC for selling unapproved products with fraudulent #COVID19 claims. https://t.co/Cu8RlxQMWq
Today we issued a set of enforcement discretion policies regarding certain provisions guidance for industry. https://t.co/ig53PKrf8n
We authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, from 6 to 9 months, allowing the product to be stored at 2-8 degrees Celsius. https://t.co/DYfgxz7l2f
Today's “FDA Roundup” includes new enforcement discretion guidance, updated FAQs on a medical device recall, a joint warning letter and a #COVID19 vaccine shelf-life extension. https://t.co/NNS3kAFZcW https://t.co/IDRURZclQJ
RT @FDA_ORA: A8: ⚠️#DYK you can report suspected criminal activity related to #FDARegulated products? Go to: https://t.co/H1PnuSjVpG to rep… QT @USAGov: Q8: Spotting a scam can be overwhelming.🔎 What information do you need to report fraud when you see it?… https://t.co/ZwMQLj8Noy)
RT @FDA_Drug_Info: Health fraud scams have been around for hundreds of years and play on the desire for a quick or miracle cure. Dur… https://t.co/9Q7iPfvgDJ
In the first 2 months of 2022, FDA approved 4 new drugs for people w/ rare diseases in the areas of oncology & hematology. We are dedicated to facilitating the development of therapies for the more than 30 million people living w/ a rare disease in the US. https://t.co/6OuzhULZyk
RT @FDADeviceInfo: Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizin… https://t.co/cMCdldjZxd
As of today, 423 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 291 molecular tests and sample collection devices, 87 antibody and other immune response tests and 45 antigen tests.
Finally, the FDA provided an update related to the recall of certain Philips Trilogy EVO ventilators. https://t.co/8V8z9EzUg7