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911 articles found
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Why Are Certain SDTM Variables "Not for Use in Human Clinical Trials"?In some cases, the reason for the restriction is fairly obvious, but in other cases, understanding the reason requires understanding the differences between how human clinical trials and nonclinical t... -
FDA Roundup: August 8, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced it is issuing a direct final rule to complete administrative a...
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FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and ProductsToday, the U.S. Food and Drug Administration issued a draft guidance which, once finalized, will assist cosmetics companies submitting cosmetic product facility registrations and cosmetic product list...
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FDA Approves Second Over-the-Counter Naloxone Nasal Spray ProductToday, the U.S. Food and Drug Administration approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment of known o...
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FDA Roundup: July 28, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA approved Ervebo, a vaccine for the prevention of Ebola virus disea...
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FDA Takes Steps to Facilitate Innovation for Devices Intended to Treat Opioid Use DisorderToday, the U.S. Food and Drug Administration announced new steps to help facilitate innovation in devices intended to treat opioid use disorder (OUD). The draft guidance, to help sponsors design clini...
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FDA Roundup: July 25, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA reopened the comment period for the 30-day procedural notice to cond...
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FDA Roundup: July 21, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA Center for Tobacco Products (CTP) announced that the center will host a...
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FDA Roundup: July 18, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA announced the findings from the voluntary pilot program to evaluate...
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FDA Approves New Drug to Prevent RSV in Babies and ToddlersToday, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born d...