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Manufacturers › Enforcement Actions › Center for Biologics Evaluation and Research (CBER)

Morgan Lewis - As Prescribed

Vaccine Suspension: FDA Leans Into Its Withdrawal Toolbox, But Will It Invite Challenges?

Morgan Lewis - As Prescribed on

On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

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