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Clock is Ticking: 1-Year until DSCSA’s Enhanced Drug Distribution Security Requirements Take Effect

Ten years in the making, and full implementation is finally coming. In about a year—beginning on November 27, 2023—prescription drug manufacturers and their supply chain partners will be required to fully trace and verify...more

FDA Finalizes ‘Instructions for Use’ Guidance on Patient Labeling for Drugs and Biologics

As companies begin planning for the upcoming year, attorneys who sit on promotional review committees should consider the significant guidance published by the U.S. Food and Drug Administration (“FDA”) and update process aids...more

Buyers Take Note: OIG Opinion Provides Insights on Physician-Owned Entities & Their Technologies

PART I- On April 20, 2022, the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued Advisory Opinion, No. 22-07 (“Opinion 22-07”), an informative opinion regarding arrangements...more

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