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278 articles found
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FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic ProductsThe U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate th... -
FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb MisuseDespite recent declines, opioids remain commonly prescribed to about 1 in 5 U.S. adults who live with chronic pain as effective alternatives are limited. As part of its broader strategy to address the...
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HHS, CBP Seize $86.5 Million Worth of Illegal E-Cigarettes in Largest-Ever OperationThe U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), and U.S. Customs and Border Protection (CBP) today announced the seizure of 4.7 million uni...
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FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug IngredientsThe U.S. Food and Drug Administration today established a “green list” import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unv...
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FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89The U.S. Food and Drug Administration today announced that it will release future complete response letters (CRLs) promptly after they are issued to sponsors. The agency also released today 89 previou...
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FDA Advances Rare Disease Drug Development with New Evidence PrinciplesThe U.S. Food and Drug Administration today introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare disease...
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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...
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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...