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  1. Office of Regulatory Affairs

FDA Efforts to Ensure Product Safety

The Food and Drug Administration uses a robust, risk-based oversight approach to ensure the continued safety of the nation’s food and medical product supply. This multi-pronged approach includes:

FDA Oversight During the COVID-19 Pandemic 

The COVID-19 pandemic created an unprecedented public health emergency that impacted FDA’s inspectional work. The agency’s expanded use of a variety of surveillance tools and development of new oversight approaches significantly contributed to our ability to protect and promote public health, while also protecting the safety of FDA staff, employees at the firms FDA inspects, and the public. 

FDA issued a report, “Resiliency Roadmap for FDA Inspectional Oversight,” in May 2021, which detailed the effect of the COVID-19 pandemic on inspectional activities and outlined our plan for returning to a more consistent state of conducting oversight of regulated industry.  

FDA issued an updated report in November 2021, which provides information on the current state of FDA oversight, and focuses on how we have exceeded the goals set in May 2021 for completing domestic surveillance inspections in FY2021.  

FY21 Highlights

  • Exceeded its goals for completing domestic surveillance inspections as outlined in the Resiliency Roadmap’s “base-case scenario.” 
  • Completed inspections and/or assessments in support of all seven of the identified mission critical applications.  
  • Made decisions on nearly half of the 68 applications reported as delayed due to a pending inspection or assessment in the Resiliency Roadmap.   
  • Exceeded its goal related to following up on previous inspections classified as official action indicated (OAI). 
  • Made more than 1,300 requests to human and animal drug and biological product manufacturers to submit records for review, which supported timely regulatory decisions.  
  • Conducted more than 130 remote regulatory assessments under the bioresearch monitoring program that were directly used in application decisions. 

For More Information

Previous Oversight Highlights

Click on the image to display the PDF in full size.

 Fiscal Year 2019 (English)     

Fiscal Year 2019 (English)         

  Año fiscal 2019 (Español) 

 Fiscal Year 2019 (Spanish)         


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