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FDA Academy - Food and Drug Administration
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Today, the FDA identified a Class I Recall, the most serious type of recall: Medtronic expanded its 2018 recall of remote controllers used with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to potential cybersecurity risks. Medtronic updated recommendations for people who may still be using the remote controllers, including instructions to stop using and return the remote controller. Find out more about this medical device recall: https://go.usa.gov/xMwr
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Today, we announced that FDA would no longer allow for the use of FD&C Red No. 3 in food and ingested drugs as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs | U.S. Food and Drug Administration
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Today, we announced that FDA would no longer allow for the use …
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Today, the FDA launched Elsa, a generative AI tool designed to help employees—from scientific reviewers to investigators—work more efficiently. This innovative tool modernizes agency functions and leverages AI capabilities to better serve the American people. Elsa in Action ➤ Accelerate clinical protocol reviews ➤ Shorten the time needed for scientific evaluations ➤ Identify high-priority inspections targets ➤ Perform faster label comparisons ➤ Summarize adverse events to support safety profile
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The U.S. just killed mRNA vaccine funding — what now?
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FDA expands eyedrop recall, cites bacterial contamination
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Pediatric group issues COVID vaccine guidance
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FDA chief disputes report the White House pressured him to authorize …
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