Clint Narver

McGuireWoods LLP

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Latest Posts › Food and Drug Administration (FDA)

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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

5/22/2025 / China , Enforcement Actions , Food and Drug Administration (FDA) , Imports , India , Manufacturers , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements , Supply Chain

Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more

1/30/2025 / Centers for Medicare & Medicaid Services (CMS) , CMMI , Drug Pricing , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , MedPAC , New Guidance , Pharmaceutical Industry

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

10/25/2024 / Clinical Trials , Draft Guidance , Food and Drug Administration (FDA) , Health Care Providers , Prescription Drugs

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