Drug Fix: The State Of Facility Inspections With Two Former Senior US FDA Execs

Pink Sheet Executive Editor Derrick Gingery and Senior Editor Sue Sutter are joined by special guests Michael Rogers, former US Food and Drug Administration associate commissioner for inspections and investigations, and Douglas Stearn, former principal deputy associate commissioner in the FDA Office of Inspections and Investigations, both now at Canal Row Advisors. They talk about the current state of the agency inspection cadre and resource challenges (1:04) and offer thoughts on the FDA’s efforts to increase foreign inspections (25:24), as well as discuss the growing threat that receiving an Official Action Indicated (OAI) classification presents (35:20) and consider whether user fee goals eventually could be impacted (45:02). More On These Topics From The Pink Sheet US FDA Use of ‘Potential Official Action Indicated’ Flag Raises Concerns About Facility-Based CRLs: https://insights.citeline.com/pink-sheet/compliance/us-fda-use-of-potential-official-action-indicated-flag-raises-concerns-about-facility-based-crls-3JLUE3CW6BEIFOKQRZ5C4FKFOM/ US FDA’s Failure To Implement Key Workforce Reforms Puts Oversight At Risk, GAO Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-failure-to-implement-key-workforce-reforms-puts-oversight-at-risk-gao-says-B64V7RAIQNBNBI57ID5ZU3DYAE/ US FDA Remote Assessments Need Clearer Closeout Process, More Transparency, Experts Argue: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-remote-assessments-need-clearer-closeout-process-more-transparency-experts-argue-4P5UQEPW7NDLNDDQERUQY5Y56M/