In this second part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with John Claud, Counsel at HPM; Peter Dickos, Counsel at HPM; and Andrew Hull, Director at HPM. Together, they discuss the current enforcement environment at FDA; foreign inspections of pharmaceuticals and how companies should respond to 483s; False Claims Act theories for liability, specifically in areas such as cybersecurity, tariffs, DEI compliance, and CID/subpoena responses; key considerations in determining whether to enter into a consent decree with the agency; trends in enforcement discretion; and much more.

This episode and the rest of our series do not include the usual Headlines and Resources Links segments.

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Music by Dvir Silver from Pixabay.