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Top FDA Officials: Agency Actively Cracking Down On Medical Products With Sham COVID-19 Claims

Executive Summary

US FDA commissioner Stephen Hahn and ORA associate commissioner for regulatory affairs Judith McMeekin said in a joint 24 February statement that the agency continues to aggressively monitor the market for firms selling products with fraudulent COVID-19 prevention and treatment claims. The officials also explained that the FDA has the authority under FDASIA to ask for records from drug manufacturers in lieu of conducting facility inspections. It can't do the same for device companies, however, because no similar provision exists. The FDA had announced on 14 February that it paused all inspections of Chinese manufacturing facilities in the near-term.

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