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.

Areas of Focus

Decades of experience allow our lawyers to prepare you for the FDA’s decision and policy-making process and map the most effective pathway to market. Some of the areas where we can advise you include:
  • Determining the regulatory status of a medical product
  • Evaluating the most viable and expedient pathways to market 
  • Developing submissions for agency rulemakings, committee proceedings, and comments
  • Creating and deploying compliant product promotional and scientific communications
  • Responding to enforcement and compliance actions
  • Preparing Citizen Petition submissions
  • Facilitating meetings with decision makers
  • Preparing RFD and pre-RFD Submissions
  • Evaluating available exclusivities and designations
  • Analyzing pending legislation and proposed rules
  • Counseling on regulatory and congressional oversight and investigations
  • Creating innovative policy and legislative proposals, preparing draft legislation and testimony and managing advocacy coalitions