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Pandemic Delayed Some FDA Plant Inspections, Product Approvals

  • Agency report details delays of mission-critical inspections
  • Regulator considering expanded use of virtual factory visits
FDA headquarters in White Oak, Md.
FDA headquarters in White Oak, Md.

Photographer: Sarah Silbiger/Getty Images

Pandemic disruptions severely hampered U.S. regulators’ ability to inspect drug and device makers’ manufacturing plants, delaying at least 68 applications for approval to market new products, according to a Food and Drug Administration review.

Seven of the delayed applications were mission-critical, meaning they represented a medical advancement, the agency said Wednesday in its report, and six of those were for new drugs. The delayed applications were among 600 where the FDA required a factory inspection before approval decisions.