Adjunct Faculty, Senior of Counsel at at Fredrikson & Byron, PA
For over 30 years, Bob has helped FDA-regulated companies navigate through regulatory agencies. During his time as general counsel for a billion-dollar medical device division, Bob developed expertise in all areas of FDA regulation. He now advises drug, medical device, and dietary supplement manufacturers on all aspects of regulation from product design through marketing.
Bob has significant expertise in the application of HIPAA and other privacy laws to manufacturers. He advises manufacturers on the Fraud and Abuse laws and other laws associated with relationships with health care practitioners, including compliance with industry codes. This involves advising on all contracts between manufacturers and health care providers. As part of this Bob advises on the reporting of payments to doctors and hospitals under the federal Sunshine Act and various state laws.