Companies engaging in clinical trials must comply with numerous federal and state laws, and if your company makes a misstep, it can derail development. Satisfying this vast set of legal requirements can be tricky, especially considering that numerous agencies oversee this sector of the health care and life sciences industries, including the Food and Drug Administration (FDA), the Office for Human Research Protections, and the Department of Health and Human Services.
Our Health Law attorneys provide regulatory and strategic advice to companies of all types and sizes involved with preclinical and clinical research. We also work with academic medical centers and research staff participating in sponsored clinical research or initiating their own studies. Our broad scope of services includes counseling investors in transactions involving FDA-regulated companies, such as public and private stock offerings and mergers and acquisitions.
Working with colleagues throughout the firm, including our life sciences industry attorneys and those in the Intellectual Property, Corporate & Securities, Antitrust, Tax, and Litigation practices, our Health Law attorneys provide integrated advice on successful product development, approval, launch, and marketing efforts. We also help them prepare for and progress through the Institutional Review Board and Stem Cell Research Oversight Committee review processes.