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  1. Office of Regulatory Affairs

Regulatory News, Stories, and Features


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Connect to the latest news, perspectives, and stories from the field

In our latest issue:

  • For New FDA Associate Commissioner, the Work of Protecting Public Health is Personal
    New Associate Commissioner for Regulatory Affairs Michael C. Rogers shares his background, career path, and vision for ORA. Rogers’ hard-won ascent from field trainee to the seat of Associate Commissioner for Regulatory Affairs, or ACRA, where he now serves as a close advisor to Dr. Robert Califf, FDA’s Commissioner, is appreciated by ORA staff.

  • Patient Advocacy Lies at Heart of FDA Agent’s Theranos Case
    Special Agent-in-Charge George Scavdis spent six years of his career seeking out patients and healthcare providers for the Theranos case. The powerful testimonies he documented helped paint a picture of how Theranos misled, and in some cases, physically or emotionally harmed, an untold number of U.S. patients.

  • ORA's Detroit Laboratory and University of Michigan Students Connect for Lab Tour
    Students from the University of Michigan's Pharmacy Community College Connect visits ORA's Detroit Medical Products Laboratory. The program, in its inaugural year, welcomes students from tribal and community colleges across the state of Michigan.

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