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FDA Issues Exemptions from November 27, 2024 Compliance Deadline for Updated DSCSA Requirements

On Wednesday, the Food and Drug Administration (FDA) issued a statement granting additional exemptions from its November 27, 2024 deadline for compliance with certain product transaction requirements.  The exemptions followed...more

OIG Approves Warranty Program for Bundled Products Used in Joint Replacement Surgery

The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) recently released Advisory Opinion 18-10, which approved a proposed arrangement involving a manufacturer of medical devices and wound care...more

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