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Suing the Certifiers – A Dangerous Undertaking

Drug & Device Law

For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards.

Doctors 52
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Court Denies Motion to Dismiss Based on Implied Preemption

Drug & Device Law

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 2012) (citing Smith–Haynie v.

FDA 59