Regulatory Oversight and Compliance

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Document Review and Quality Control Concept. Document with a checkmark, quality assurance, and process control. auditing, compliance, verification, data inspection, and business workflow management. | Image Credit: © Supatman - stock.adobe.com
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

July 4th 2025

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS). | Image Credit: © Tada Images - stock.adobe.com
FDA Posts Slate of Seven Warning Letters Following Company Inspections

June 12th 2025

Cambridge, MA, USA - June 29, 2022: Moderna logo is seen at the entrance to its headquarters in Cambridge, Massachusetts. Moderna, Inc., is an American pharmaceutical and biotechnology company. | Image Credit: © Tada Images - stock.adobe.com
FDA Approves New Moderna COVID-19 Vaccine mNEXSPIKE

June 2nd 2025

A doctor in a white lab coat shaking hand showing symbol of medicine innovation, treatment, discovery and healthcare analysis. | Image Credit: © chadchai - stock.adobe.com
Geopolitical Shifts Change Nature of Pharma Partnerships

May 28th 2025

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FDA Grants Fast Track Designation to Q32 Bio Treatment for Alopecia Areata

April 30th 2025

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