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New FDA Draft Guidance on Conducting Remote Regulatory Assessments

On July 22 of 2022, the U.S. Food and Drug Administration (FDA) released new draft guidance entitled Conducting Remote Regulatory Assessments: Questions and Answers. Remote regulatory assessments (RRAs) are a tool adopted during the COVID-19 pandemic to assess compliance with applicable FDA requirements.

What is the purpose of the draft guidance?

It is intended to help establishments clarify how the FDA requests, conducts, and uses RRAs.  It includes questions and answers regarding the following topics:

  • Remote Regulatory Assessment Fundamentals
  • Remote Regulatory Assessment Expectations
  • Requests for Records or Other Information as Part of Remote Regulatory Assessments
  • Completion of a Remote Regulatory Assessment

 

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Conducting Remote Regulatory Assessments View Draft Guidance