Robert Califf Talks Verily, Hopes Gottlieb Can Push Back On Trump
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.
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It was a somewhat muted launch today of the agency's long-awaited "program alignment" facility inspectional approach.
'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.
The agency says it has sent letters to dozens of companies that have made ‘FDA Registration Certificate’ claims or used the agency’s logo without authorization, which could lead customers to think the products have been vetted.