Walter F. Mondale Hall 229–19th Ave. South Minneapolis, MN 55455
Indiana University, B.A.
University of Michigan, J.D.
Professor Ralph F. Hall is a professor of practice at the Law School and is Of Counsel to the law firm of Faegre Baker Daniels where he counsels clients in the area of drug and medical device regulation and corporate compliance matters. He also serves as CEO of MR3 Medical LLC, a start-up medical device company. He is a frequent speaker on FDA regulatory issues and compliance matters and has testified a number of times before Congressional committees.
Prior to his association with the University of Minnesota Law School, Professor Hall served in various capacities with Guidant Corporation including Senior Vice President and Deputy General Counsel—Litigation and Compliance and General Counsel of the Cardiac Rhythm Management group. During this time, Professor Hall also served as Special Counsel to the Guidant Board of Directors Compliance Committee and as Counsel to the Guidant Chief Compliance Officer. Prior to joining Guidant, he was with Eli Lilly, including serving as the head of Lilly's worldwide environmental law group.
Professor Hall received his B.A. from Indiana University in 1974 and his J.D. from the University of Michigan where he was a Weymouth Kirkland Scholar. Professor Hall's interests include FDA regulation, corporate compliance and governance, negotiations and the interface between corporate practice and the academic world.
Corporate Integrity Agreements, in James T. O'Reilly et al., Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations 97 (Oxford University Press, 2009)
Deferred Prosecution and Non-Prosecution Agreements, in James T. O'Reilly et al., Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations 119 (Oxford University Press, 2009)
Understanding and Complying with Compliance Agreements, in James T. O'Reilly et al., Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations 155 (Oxford University Press, 2009)
Remedies of Disgorgement and Restitution, in James T. O'Reilly et al., Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations 181 (Oxford University Press, 2009)
FDA Regulation of Drugs, in Nanotechnology & FDA-Regulated Products: The Essential Guide 43 (Food and Drug Law Institute, 2009)
FDA Regulation of Medical Devices, in Nanotechnology & FDA-Regulated Products: The Essential Guide 75 (Food and Drug Law Institute, 2009)
Rethinking Lohr: Does"SE" Mean Safe and Effective, Substantially Equivalent, or Both?, 13 Minnesota Journal of Law, Science & Technology 737 (2012)
(with Michelle Mercer)
Enforcing the Rights of Human Sources to Informed Consent and Disclosures of Incidental Findings from Biobanks and Researchers: State Mechanisms in Light of Broad Regulatory Failure, 13 Minnesota Journal of Law, Science & Technology 575 (2012)
(with Leili Fatehi)
Recommendations for Oversight of Nanobiotechnology: Dynamic Oversight for Complex and Convergent Technology, 13 Journal of Nanoparticle Research 1345-1371 (2011)
(with Gurumurthy Ramachandran, Susan M. Wolf, Jordan Paradise, Jennifer Kuzma, Efrosini Kokkoli & Leili Fatehi)
Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology, 37 Journal of Law, Medicine & Ethics 598 (2009)
(with Jordan Paradise, Alison W. Tisdale & Efrosini Kokkoli)
Developing Oversight Frameworks for Nanobiotechnology, 9 Minnesota Journal of Law, Science & Technology 399 (2008)
(with Jordan Paradise, Susan M. Wolf, Gurumurthy Ramachandran, Efrosini Kokkoli & Jennifer Kuzma)