On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more
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
FDA on September 23 issued a Drug Supply Chain Security Act (DSCSA)– related compliance policy stating it will not take enforcement action against wholesalers that do not have systems in place to verify product identifiers of...more