Working across every dimension of academic medicine, Polsinelli attorneys advise academic medical centers, other health care providers and researchers on a diversity of legal and policy issues. Our counsel is anchored in a deep understanding of the health care industry and each sector of academic medicine and clinical research.
Polsinelli attorneys help clients achieve key business objectives related to the full array of products regulated by the Food and Drug Administration, as well as related health and safety regulatory agencies, in the face of state, national, and global regulatory concerns.
Polsinelli is enhanced by capabilities in the area of government investigations and regulatory advocacy. Included in its representation of academic medical centers, Polsinelli attorneys represent Comprehensive Cancer Centers and two PPS-Exempt Cancer Hospitals. We have helped academic medical centers, health systems, hospitals, physician groups and research networks across the country in negotiating clinical trial agreements, assuring clinical research compliance, defending against government investigations related to clinical research, and creating research collaborations. Combining the experience of our academic medicine and government investigations team, we regularly advise academic medical centers on investigations into academic misconduct as well as clinical trial billing concerns.
Our work covers products regulated by Food and Drug Administration (FDA), as well as the U.S. Department of Agriculture (USDA), Consumer Product Safety Commission (CPSC), Federal Trade Commission (FTC), Public Health Service (PHS), Environmental Protection Agency (EPA), U.S., Customs and Border Protection (CBP), National Institutes of Health (NIH) and the Drug Enforcement Administration (DEA).