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's accounts: US_FDA
Tracking Since: October 16, 2019
These guiding principles will help to advance high quality artificial intelligence/machine learning-enabled medical device development, which has the potential to significantly improve the quality of patient care and transform health care.
These ten principles are intended to identify areas where alignment in efforts related to research, building resources and tools, regulatory policies, regulatory guidelines, international harmonization, and consensus standards could be developed.
Today, the FDA, @GovCanHealth and @UK_HealthCare jointly issued the “Good Machine Learning Practice for Medical Device Development: Guiding Principles.” https://t.co/QJzEpAZWGM https://t.co/KAbw6NWOxH
In our ongoing response to the #COVID19 pandemic, here’s an update on some of the actions we’ve taken. https://t.co/rZ49twE3Hu https://t.co/sSsqjrLiDA
RT @FDA_Drug_Info: Comfortable asking your doctor questions when you receive lab results you don’t understand? Make informed decision… https://t.co/0LNb7epYJ0
An update to yesterday’s outbreak alert on onions – We’ve identified another onion supplier to the alert, and one supplier has issued a recall. More: https://t.co/QPzbxvmVRb https://t.co/Oj3aODPTsM
In order to protect public health, it’s important that we ensure all new tobacco products undergo our scientific premarket evaluation. Here’s our latest ⬇️ QT @FDATobacco: On 10/19, FDA issued marketing granted orders to U.S. Smokeless Tobacco Company LLC (USSTC) for 4 oral tobacco prod… https://t.co/XTSMOe0vsd)
RT @FDATobacco: On 10/19, FDA issued marketing granted orders to U.S. Smokeless Tobacco Company LLC (USSTC) for 4 oral tobacco prod… https://t.co/XTSMOe0vsd
In order to protect public health, it’s important that we ensure all new tobacco products undergo our scientific premarket evaluation. Here’s our latest⬇️ QT @FDATobacco: On 10/19, FDA issued marketing granted orders to U.S. Smokeless Tobacco Company LLC (USSTC) for 4 oral tobacco prod… https://t.co/XTSMOe0vsd)
Advanced manufacturing helps strengthen drug manufacturing & increases the supply of quality medical products for consumers – FDA has established numerous initiatives to better understand the science of advanced manufacturing. #FDAVoices https://t.co/X7TDFY8ZGx
In our ongoing response to the #COVID19 pandemic, here’s an update on some of the actions we’ve taken this week. https://t.co/dtxaZibqon
FDA is withdrawing the temporary policies outlined in the guidances for the preparation of certain alcohol-based hand sanitizer products and alcohol for use in hand sanitizers effective Dec. 31, 2021. https://t.co/4ShHILkmef
As of today, 416 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 291 molecular tests and sample collection devices, 89 antibody and other immune response tests and 36 antigen tests.
RT @FDA_Drug_Info: No matter how hard we fight it, our body changes over time. Follow these tips to use medicines safely & avoid unw… https://t.co/TCBWHfMhkJ
RT @FDAOncology: The MicroArray Quality Control consortium—a 16-year international effort led by the FDA and involving hundreds of s… https://t.co/ihMOjbUigI
RT @FDA_Drug_Info: Join FDA and @DukeMargolis for a virtual public workshop on October 13-14 to reconsider mandatory prescriber educat… https://t.co/xdgKMRJA89
Are you prepared for a #naturaldisater? Your kit should include food and water as well as supplies to ensure your food remains safe. #Beprepared #NatlPrep https://t.co/juWFWHucWw https://t.co/yf7fKiJ5QD
Today, we announced revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome following vaccination.
Based on an analysis of Vaccine Adverse Event Reporting (VAERS) data, there have been 100 preliminary reports following vaccination with the Janssen vaccine after approximately 12.5 million doses administered.