US FDA's 'Program Alignment' Inspection Scheme Begins
It was a somewhat muted launch today of the agency's long-awaited "program alignment" facility inspectional approach.
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US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.
Former US FDA Commissioner Robert Califf is joining the health-technology firm Verily, a Google spin-off. In a podcast interview with Medtech Insight, he discussed his new advisory role with the company and said he hopes the new FDA Commissioner Scott Gottlieb will be strong in standing up to any "whimsical directives" from President Trump.
'Program Alignment' Falls Into Place: Everything You Need To Know About US FDA's New Inspectional Approach
For the medical device industry, FDA's five regional offices – Pacific, Central, Northeast, Southwest, Southeast – will be replaced by three distinct divisions across the US encompassing 20 FDA district offices on May 15. Check out the latest US map from the agency showing where the device divisions will be located, and find out what your firm will be facing at its next facility inspection.