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911 articles found
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Coronavirus (COVID-19) Update: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test TypesToday, the U.S. Food and Drug Administration updated its COVID-19 test policy to ensure continued access to tests while encouraging the transition of these important public health tools to traditional... -
FDA Roundup: September 23, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “FDA Issues New Guidance to Help Facilitate A...
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New FDA Draft Guidance Aims to Protect Children who Participate in Clinical TrialsToday, the U.S. Food and Drug Administration issued a draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in...
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FDA Roundup: September 20, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA alerted medical device users about a potential cybersecurity risk for t...
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FDA Committed to Strengthening U.S. Infant Formula Supply; Review Provides Roadmap to Support Ongoing EffortsFor the past several months, the U.S. Food and Drug Administration has been working around the clock with our U.S. government partners, including the U.S. Department of Health and Human Services and t...
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FDA Concludes Internal Review of Agency Actions Related to the U.S. Infant Formula SupplyIn May 2022, FDA Commissioner Robert M. Califf, M.D., asked that I conduct an internal agency review of the agency’s actions related to multiple reports of Cronobacter illness in infants, the Abbott’s...
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FDA Roundup: September 16, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Wednesday, the FDA announced that it is taking steps to help increase the availabil...
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FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative DiseasesToday, the U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partn...
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FDA Roundup: September 13, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA reissued the Aug. 19, 2022, letter of authorization for Novavax COV...
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FDA Roundup: September 9, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted FAQs on Testing for Monkeypox with answers to frequently asked...