FDA Preparedness

Thanks for following. The FDA_MCMi account has a new name: @FDApreparedness. Learn more about the new FDA Office of Public Health Preparedness and Response: fda.gov/about-fda/offi…

The FDA is committed to promoting patient access to safe and effective medical products and ensuring a secure food supply. Learn more about how we work with @HHSgov and other partners to address shortages of FDA-regulated products: fda.gov/emergency-prep…

Read our statement on #MedicalDevice supply chain vulnerabilities, the public health impact they have on our most vulnerable populations, such as neonatal and pediatric patients, our actions to prevent and mitigate potential shortages, and solutions. fda.gov/medical-device…

It’s a new Year, but you may not need a new test! Before you toss, check the dates of your at-home covid tests. Your tests might still be good—check the FDA website for extended expiration dates on many at home covid-19 tests. fda.gov/covidtestdates…

Today, the @US_FDA issued the final guidance titled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act. Find out more: fda.gov/regulatory-inf…

Today, @US_FDA announced the availability of a draft guidance for industry titled “Study of Sex Differences in the Clinical Evaluation of Medical Products.” Read it to learn why analyzing sex-related differences in medical product response matters. fda.gov/regulatory-inf…

An #AntimicrobialResistance (AR) threat somewhere can become a threat anywhere. Modern travel of people, animals, and goods means AR can easily spread. Take precautions to help ensure a healthy and safe travel season and help combat AR at the same time: bit.ly/2ATfgIN

#ICYMI: 📢 Join #CDERSBIA on December 10-12 for a virtual training course to provide participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. Register today ➡ fda.gov/drugs/news-eve…

Learn more about how you can safely use antibiotics so you can get well, protect yourself and your family, and combat antimicrobial resistance. #USAAW24 fda.gov/consumers/cons…

Antibiotics are powerful medications that save countless lives every day. But they’re not the answer for every illness. Talk to your health care professional about the best treatment for you when you are sick. #USAAW24 youtu.be/ZE_1_3TRvIk

Today, the @US_FDA issued the final guidance, “510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review.” This guidance supersedes the previous "510(k) Third Party Review Program" guidance. fda.gov/regulatory-inf…

Antibiotic and antifungal drugs are valuable tools for treating infections, but any time they are used they can cause side effects and contribute to #AntimicrobialResistance (AR). Learn how the appropriate use of these drugs can help fight AR: bit.ly/3zhewOm #USAAW24

CDC issues Health Alert Network (HAN) Health Advisory to provide information about the first case of clade I mpox diagnosed in the U.S. and recommendations to clinicians about preventing, diagnosing, treating, and reporting mpox cases. Read full alert: bit.ly/4exL5q8

Holiday celebrations are approaching. With an increase in social gatherings comes the likelihood of an increase in positive COVID-19 cases. Testing helps prevent and contain the spread of COVID-19. fda.gov/covidtestdates…

CDC has #H5N1 #birdflu resources that are searchable by language. Fact sheets, videos, infographics, and other resources in multiple languages are available for partners. More here: bit.ly/3TRP4X5

U.S. Antibiotic Awareness Week starts soon! ‘Go Purple’ anytime during November 18-24 to show how we all play a role in fighting #AntimicrobialResistance. Learn how you can ‘Go Purple’ and encourage others to do the same for #USAAW24 bit.ly/4bo2Bf1

📣 Join #CDERSBIA on December 10-12 for a virtual training course to provide participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, & in accordance with regulatory standards. Learn more & register today ➡ fda.gov/drugs/news-eve…

Missed One Health Day? Take time now to reflect that the best possible health outcomes are achieved by considering the interconnectedness of humans, animals & the environment. See @FDAanimalhealth for more info and to sign up for an upcoming symposium: fda.gov/animal-veterin…

One Health involves everyone. A successful #OneHealth approach to public health involves many experts working together to improve the health of people, animals — including pets, livestock, and wildlife – plants, and the environment. #OneHealthDay bit.ly/3YinvIV

If you work with dairy cows or other animals that could be infected with #birdflu, take action to reduce your risk of infection. Read more here: bit.ly/4dADJBK

FDA announced extended use dates for some parenteral drug products, after a review of the stability data submitted by Baxter International: fda.gov/drugs/updates-… Search FDA's list of extended use dates to assist with drug shortages: fda.gov/drugs/drug-sho…