Experienced advisors for FDA-regulated companies
Navigating the market pathways for FDA-regulated products requires a full-time focus on constantly changing federal rules and deep experience in the regulatory and legislative processes. Our FDA practice provides the innovative counsel and constant diligence that companies need to bring products to market and have a voice in regulatory processes that affect their business.
We represent an array of FDA-regulated companies, working closely with biotechnology, pharmaceuticals, medical devices, advanced diagnostics, human tissue and healthcare organizations to help them smoothly bring products to market. We understand the regulations and policies affecting the entire product development process, from investigations, testing, and manufacturing to approvals, clearances, licensure, and marketing, to post market compliance and enforcement.
A number of our lawyers have worked within the FDA and served as senior congressional staff. In addition to helping develop foundational and crosscutting regulations and FDA policies, they helped craft major FDA laws, including the Orphan Drug Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and key elements of the FDA Reauthorization Act of 2017 and the 2012 Food and Drug Administration Safety and Innovation Act. Our work with agency officials and Congress has helped to shape FDA policies and enact legislation.