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FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

Final Definitions and Considerations for Trading Partners to Prepare for DSCSA Implementation

On March 16, 2023, the Food and Drug Administration (FDA) released final guidance regarding definitions of "suspect product" and "illegitimate product" as part of a continued effort to prepare trading partners for the...more

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