Foley Hoag’s Food and Drug Practice provides regulatory and legislative advice to leading biotechnology, pharmaceutical, medical device, and health care companies regulated by the Food and Drug Administration (FDA). Lawyers at Foley Hoag understand the critical regulations and policies affecting product development schedules, regulatory compliance, and timely product approvals. In representing clients, our lawyers work with senior agency managers, congressional staff, and Members of Congress to shape agency interpretations, clarify regulatory guidance, challenge adverse decisions, develop effective compliance plans, and enact legislation into law.
Our lawyers have served as senior congressional staff, during the enactment of nearly every major food and drug law over the past two decades and routinely provide counsel to clients in these areas, including amendments to the Orphan Drug Act; the Prescription Drug User Fee Act of 1992 (PDUFA) and its subsequent reauthorizations; the Safe Medical Devices Act of 1990; the Nutrition Labeling and Education Act of 1990 (NLEA); the Dietary Supplements Health and Education Act of 1994 (DSHEA); the Health Insurance Portability and Accountability Act of 1996 (HIPAA); the Food and Drug Administration Modernization Act of 1997 (FDAMA); the Best Pharmaceuticals for Children Act (BPCA); the Public Health Security and Bioterrorism Preparedness and Response Act; and the Medical Device User Fee and Modernization Act of 2002 (MDUFA). More recently, our lawyers have worked with congressional staff and industry on key elements of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and continue to provide assistance to clients and congressional and agency staff on implementation of this legislation.
Topics covered include:
- FDA Regulatory Strategies
- Federal Legislative Advocacy
Download the Foley Hoag Food and Drug Datasheet (.pdf)