Food & Drug Law

Every day our clients are developing new and exciting products that shape the future of health care and wellness for patients and consumers. While making important advances in medical products and food, they also face multiple challenges. We help clients overcome these hurdles by engaging with the U.S. Food and Drug Administration (FDA) and other global and state regulators. We also advise clients on the best way to secure investments for new research and development, and to manage the ongoing risk of high-stakes investigations, enforcement actions and recalls that could potentially result in litigation.

From your initial concept until your new product is in the hands of consumers, our team will work with you during all stages of the product’s life cycle. To do this, we guide you through a product’s research and development, review and approval, commercialization, postmarket obligations and modifications. We can handle any compliance or enforcement challenges that arise. We also make sure that your business transactions and compliance programs adhere to all applicable laws and FDA regulations.

By combining our lawyers’ in-depth and firsthand knowledge of FDA regulations and public policy advocacy with the resources of a full-service global law firm, our food, drug and device practice effectively:

Provides regulatory and strategic advice to clients during product development, the application and approval or clearance process, and postmarket.
Advises clients on FDA-related compliance issues, and represents clients in enforcement actions brought by FDA, the Department of Justice (DOJ) and other authorities.
Performs due diligence and develops agreements relating to investments and transactions in FDA-regulated companies and products.
Develops and executes advocacy strategies for policy and legislative reforms relating to FDA-regulated products.
Counsels clients on international requirements for medical products and foods.