Overview
Navigating approval for food and drug products requires a full-time focus on constantly changing federal rules and deep experience in the regulatory and legislative processes. Foley Hoag’s FDA practice provides the seasoned, innovative counsel and constant diligence that companies need to bring products to market and have a voice in regulatory processes that affect their business.
Foley Hoag, a leading law firm with offices in Boston, Washington, D.C., New York and Paris, represents biotechnology, pharmaceutical, medical device, advanced diagnostic, and health care companies regulated by the Food and Drug Administration (FDA). The firm’s FDA Practice lawyers have decades of experience understanding the regulations and policies affecting product development schedules, regulatory compliance, and product approvals.
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That experience enables our lawyers to anticipate and inform FDA decision and policy making, and to develop competitive, business-focused regulatory strategies for their clients. These strategies can include:
- determining the regulatory status of a medical product
- assessing and counseling sponsors on the most viable pathways to market
- developing submissions for agency rulemakings, committee proceedings, etc.
- preparing responses to enforcement and compliance actions
- facilitating meetings with decision makers
- analyzing pending legislation and proposed rules
- counseling clients on regulatory and congressional oversight and investigations
- creating innovative policy and legislative proposals, preparing draft legislation and testimony, and managing advocacy coalitions
Many of our FDA practice lawyers have worked inside the FDA and served as senior congressional staff developing major food and drug laws, including the Orphan Drug Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and, most recently, key elements of the FDA Reauthorization Act of 2017 and the 2012 Food and Drug Administration Safety and Innovation Act. They work with senior agency officials, 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.
Regulatory and legislative compliance is integral to the food and drug development business. Partnering with Foley Hoag’s FDA Practice enables companies to address that need while maintaining their focus on development and innovation.
