FDA Policy/General

8 Inspection Takeaways from New FDA Law

David McFarland

— 1 min read
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Two former FDAers, now working with Greenleaf Health, list eight key takeaways from the new Food and Drug Omnibus Reform Act that was signed into law on 12/29/22. The article was written by Donald Ashley, who was FDA Office of Compliance director for six years, and Kalah Auchincloss, whose six years at FDA were in the Commissioner’s Office and in CDER’s Office of Compliance and Office of Regulatory Policy.

Writing in Cell & Gene they list the takeaways as:

  • expanding the availability of alternative tools to inspection;
  • clarifying the statutory basis for bioresearch monitoring inspections;
  • recognition of foreign government inspections;
  • regional compliance history added as a surveillance inspection criterion;
  • GAO directed to prepare a report on alternative tools used by FDA and foreign counterparts;
  • expect more unannounced foreign inspections;
  • previously sunset provisions to prevent shortages in enforcement cases are revitalized; and
  • annual report on inspections.

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