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Public Policy Newsletter Article

FDA Issues FAQ Guidances on Pandemic Inspections

  • 2020-08-27T15:00:00.000+0000
  • Washington DC
  • Author: Brittany Blocker

On August 19, the Food and Drug Administration issued a frequently asked questions guidance explaining its approach to inspections and manufacturing and supply chain changes during the COVID-19 pandemic. Last month, FDA resumed mission-critical domestic inspections on a case-by-case basis. FDA explains that an inspection is mission-critical if the product has a breakthrough therapy designation or regenerative medicine advanced therapy designation, or it is used to diagnose, treat or prevent a serious disease without an appropriate therapeutic alternative.

For pre-approval inspections, FDA will use existing inspection reports from other trusted regulatory partners through mutual recognition and confidentiality agreements, requesting information from applicants, and requesting records and other information directly from facilities and other inspected entities.
FDA clarifies that both for-cause and pre-approval inspections can be deemed mission-critical and that it will consider the safety of its staff and employees at the site, as well as clinical trial participants and patients when deciding whether to conduct an inspection.

In cases where travel restriction prevents FDA from conducting preapproval inspections, FDA says it will not automatically issue a complete response letter for the application and that any decisions related to an application will be based on the totality of information available to the agency.