Reports of anaphylaxis associated with the use of glatiramer acetate have prompted the Food and Drug Administration (FDA) to add a Boxed Warning to the prescribing information.
Class 1 recalls pose serious health risks, from undeclared allergens to bacterial contamination. Here’s how Class 1 recalls work, plus major FDA food recalls in 2025.
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
Susan Krause of Rosemount alleges New Jersey-based Integra LifeSciences pressured her to lie to regulators. Integra says ...
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