Faegre Baker Daniels advises manufacturers of all types of therapeutic products regulated by the Food and Drug Administration (FDA). Our team includes former FDA regulatory counsel, two former assistant U.S. attorneys, and several former counsel for global pharmaceutical and medical device companies.

Premarket Regulatory Strategy

We counsel on premarket regulatory strategy for all types of FDA-regulated therapeutic products, including  drugs, devices, biological products, combination products, and human cells and tissues and cellular- and tissue-based products (HCT/Ps). We advise on the reimbursement landscape and work with clients to develop FDA strategies that will suit their goals while maximizing reimbursement potential.

Clinical Trials

We counsel on all aspects of FDA and HHS Office of Human Research Protection regulatory requirements for clinical trials of FDA-regulated products, and we draft and review clinical trial contracts to ensure they include the unique provisions required. We advise on informed consent, institutional review board (IRB), investigational new drug (IND) applications, investigational device exemption (IDE) applications, and HIPAA and privacy concerns. We also represent clinical investigators in disqualification proceedings. 

FDA Review Process

Our team provides support during the FDA's entire review of a product. We understand how the agency works and can interpret what it says. Our lawyers advise clients on the agency's human side as well as on legal requirements, interfacing directly with the agency when appropriate or playing a supporting role in our clients' interactions with the agency.

Post Approval and Marketing

We review promotional materials for regulated products under both FDA and Federal Trade Commission (FTC) requirements. Our attorneys support clients during inspections, Form 483 and Warning Letter responses, as well as recalls. We regularly advise clients on state marketing code concerns as well as Sunshine reporting requirements.