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FDA to Expand Unannounced Inspections of Foreign Facilities — Manufacturers, Research Firms Should Prepare

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products...more

Recent FDA Guidance Signals Future Growth for Decentralized Clinical Trials

On Sept. 18, 2024, the U.S. Food & Drug Administration (FDA) issued a final guidance document titled “Conducting Clinical Trials With Decentralized Elements, Guidance for Industry, Investigators, and Other Interested...more

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