Clinical Outcome Assessments (COA) Qualification Program Resources

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.

November 3, 2025, Dreyer’s Grand Ice Cream, Inc. is voluntarily recalling a limited number of its Häagen-Dazs Chocolate Dark Chocolate Mini Bars that may contain undeclared wheat. Those with an allergy or severe sensitivity to wheat run the risk of serious or life-threatening allergic reaction if th

The 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 unverified foreign sources from entering the U.S. market.

The results of research studies conducted GDUFA initiatives provide new tools for FDA to evaluate generic drug equivalence.

ICU Medical is correcting the Plum Duo infusion system due to pump software issues that may cause the device to become unresponsive.