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256 articles found
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FDA Permits Marketing of First Point-of-Care Hepatitis C RNA TestToday, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used to b... -
FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical StudiesToday, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist me...
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FDA Roundup: June 25, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA issued a Small Entity Compliance Guide to assist small entities in c...
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FDA Roundup: June 21, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published final guidance titled Circumstances that Constitute Delaying,...
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FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After Extensive Scientific ReviewFollowing an extensive scientific review, the U.S. Food and Drug Administration today authorized the marketing of four e-cigarette products in the United States through the premarket tobacco product a...
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FDA Roundup: June 18, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a request for input about patient safety associated with certa...
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Biden-Harris Administration Announces National Strategy to Reduce Food Loss and Waste and Recycle OrganicsToday, the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the U.S. Environmental Protection Agency (EPA) announced the “National Strategy for Reducing Food Los...
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FDA Roundup: June 11, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued an advisory warning consumers and retailers to not eat, sell, or...
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Justice Department and FDA Announce Federal Multi-Agency Task Force to Curb the Distribution and Sale of Illegal E-CigarettesThe U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA) today announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-...
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FDA Roundup: June 7, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced that it has advised the manufacturers of the licensed and auth...