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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.
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We authorized the MaximBio ClearDetect COVID-19 Antigen Home Test, an over-the-counter (OTC) COVID-19 antigen test, where validation data were gathered through the FDA’s collaboration with the NIH Independent Test Assessment Program (ITAP). https://www.fda.gov/media/155632/download …
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We recently approved an abbreviated new drug application for a corticosteroid. https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=214297#53 …
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We also updated the In Vitro Diagnostics EUAs – Molecular and Antigen Diagnostic Tests for SARS-CoV-2 web pages to share the latest information. The update added details about the design of SARS-CoV-2 diagnostic tests.https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2 …
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Over the weekend, we provided an answer to this frequently asked question: “Can I use an authorized at-home COVID-19 diagnostic test if it was left outside in freezing temperatures?”https://twitter.com/US_FDA/status/1485023151083999239 …
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We posted an at-a-glance fact sheet today for the FDA Food Safety Modernization Act final rule on Laboratory Accreditation for Analyses of Foods. The rule establishes a laboratory accreditation program for the testing of food in certain circumstances. https://www.fda.gov/media/155663/download …
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We also proposed a new rule today to amend our regulation (21 CFR 170.105) on how and when the FDA may determine that a notification for a food contact substance is no longer effective.https://www.fda.gov/food/cfsan-constituent-updates/fda-proposes-new-rule-revise-procedures-and-update-reasons-revoking-authorizations-food-contact …
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Today, we issued two final guidances to provide recommendations for including patient perspectives in medical device clinical studies. 1) https://go.usa.gov/xtN4h 2)https://go.usa.gov/xtN23
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Today's “FDA Roundup” includes updates on another authorized OTC COVID-19 antigen test, updated In Vitro Diagnostics EUAs, a new drug approval, and info on two final guidances regarding medical device clinical studies. https://www.fda.gov/news-events/press-announcements/fda-roundup-january-25-2022 …pic.twitter.com/X1cbziA50D
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We've approved vaccines to help prevent cervical cancer caused by
#HPV. Ask your health care provider if you should get the HPV vaccine at your next appointment. http://go.usa.gov/xeM6Y#CervicalHealthMonthpic.twitter.com/VUNp25hYMA
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You've already had
#COVID19, so why do you still need to get vaccinated or a booster? Dr. Peter Marks is here with the answer in this edition of "Just a Minute!"pic.twitter.com/mkygBZfpRlJust a Minute! - Had COVID?Thanks. Twitter will use this to make your timeline better. UndoUndo -
#DYK depending on how much or how little hormone your thyroid makes, you may often feel restless or tired, or you may lose or gain weight? Check in with your healthcare provider to ensure your thyroid is functioning properly. http://go.usa.gov/xeM6D#ThyroidAwarenessMonthpic.twitter.com/yhFTBhCwjD
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In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.
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Because data shows these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the U.S., these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.
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Today, the FDA revised the authorizations for two monoclonal antibody treatments to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. https://go.usa.gov/xt5D7 pic.twitter.com/Qi9S5P4ZgB
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Stay active this new year, as if your life depends on it. And don't forget to save the date for
@FDAOncology's National Black Family Cancer Awareness Week! https://go.usa.gov/xehQH#OCEProjectCommunity#BlackFamCanpic.twitter.com/uf9Fh8yUlD
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Whether it’s your
#Flu or#COVID19 vaccine or both, there’s no better time than NOW! So, what are you waiting for? Just Do It!#NationalJustDoItDaypic.twitter.com/vw6FPgOMawNational Just Do It DayThanks. Twitter will use this to make your timeline better. UndoUndo -
However, if tests are used while still cold, it may impact performance. This is why we recommend bringing the test to room temperature for 2 hours before using it.
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Test developers perform stability testing to ensure that the test performance will remain stable when tests are stored at various temperatures, including shipping during the summer in very hot regions and in the winter in very cold regions.
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Bring the test to room temperature for at least 2 hours before using it and check that the test line(s) appear as described in the instructions.
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