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911 articles found
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FDA Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging Following Increasing Reports of Accidental ExposureThe U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure. From April 1, 2022, to Marc... -
FDA Begins Real-Time Reporting of Adverse Event DataToday, the U.S. Food and Drug Administration began daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS). This represents a significant step forward in modernizi...
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HHS Allows FDA Emergency Use of Animal Drugs to Combat New World Screwworm, Protect U.S. Food SupplyThe U.S. Department of Health and Human Services (HHS) today issued a declaration that allows the U.S. Food and Drug Administration (FDA) to issue Emergency Use Authorizations (EUAs) for animal drugs...
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Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid ProductsToday I applaud Florida Attorney General James Uthmeier’s bold efforts to protect Floridians by filing an emergency rule to classify certain concentrated forms of 7-hydroxymitragynine, also known as 7...
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FDA Commissioner Makary, USDA Secretary Rollins Celebrate Proposed Modernization of Orange Juice Regulations to Benefit American GrowersU.S. Food and Drug Administration Commissioner Dr. Marty Makary, M.D., M.P.H., and U.S. Secretary of Agriculture Brooke L. Rollins this week announced plans to support American citrus growers and cut...
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A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: Announcing Resolution of the IV Saline Solutions ShortageI am pleased to announce that the nationwide shortage of sodium chloride 0.9% injection products, a form of intravenous (IV) saline, has officially ended. This marks a significant milestone for public...
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FDA Announces New FDA PreCheck Program to Boost U.S. Drug ManufacturingThe U.S. Food and Drug Administration today announced FDA PreCheck, a new program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the co...
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FDA Names Top HHS Lawyer as Chief CounselWASHINGTON — The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced that Sean Keveney has been appointed Chief Counsel at the FDA. Keveney m...
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FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize RisksThe U.S. Food and Drug Administration is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use. These changes f...
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FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American ConsumersThe U.S. Food and Drug Administration today is taking a bold step to protect Americans from dangerous, illegal opioids by recommending a scheduling action to control certain 7-hydroxymitragynine (also...