Innovative drugs often mean new treatment options for patients and advances in health care for the American public.
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Drug Development Considerations for the Treatment of Neonatal Enterovirus Infection and Congenital Cytomegalovirus Infection–Virtual Public Workshop – 05/07/2024
The Food and Drug Administration is holding a public, two-day workshop entitled Development of Drugs for the Treatment of Congenital Cytomegalovirus (CMV) Infection and Neonatal Enterovirus Infection.Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries.Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”
Hartford Bakery, Inc. is voluntarily recalling six lots of its “Lewis Bake Shop Artisan Style 1/2 Loaf” as this product may contain undeclared hazelnuts. People with a nut allergy or severe sensitivity to hazelnuts run the risk of serious or life-threatening allergic reactions if they consume theseGregory’s Foods Issues Allergy Alert on Undeclared Peanuts in “Bag Full of Cookies” White Chocolate Macadamia Nut Frozen Cookie Dough
Gregory’s Foods, Inc. of Eagan, MN is recalling its 2-pound 8.5-ounce packages of “Bag Full of Cookies” White Chocolate Macadamia Nut frozen cookie dough because some units may contain undeclared Peanut. Frozen Monster Cookie Dough, which contains Peanut, may be packaged in a bag that is labeled asInfant Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits Due to Risk for Inadvertent Adapter Disconnection During Ventilation
AirLife Infant Heated Wire Circuits heat up gas during ventilation. An included adapter may disconnect when the device reaches operating temperature.Safety Labeling Change Orders
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require application holders for certain drugs to make labeling changes based on new safety information. Learn more.