McCarter & English advises a diverse mix of companies regulated by the U.S. Food and Drug Administration (FDA) – biopharmaceutical, device, food, dietary supplement and cosmetics. Whether companies are start-ups or Fortune 500 global corporations, our team understands the complex regulatory and compliance issues relevant to these specific industries and appreciates the business needs they face.
We are committed to providing strategic and timely advice that is tailored to each company’s business goals, needs, interests and unique corporate culture. We work cross-functionally, swiftly and efficiently, and draw upon our highly experienced colleagues in our Intellectual Property, Product Liability and Corporate practices to ensure a 360-degree view on any given matter.
Advantageous to drug, biotechnology, and medical device companies, we represent clients across the product cycle. From business planning and development (potential abbreviated and other regulatory approval pathways, clinical trials, and product approval) through post-marketing (manufacturing, sales and marketing, lifecycle management, and adverse event and other reporting requirements), we assist with corporate due diligence and the negotiation of corporate agreements, and respond quickly to agency enforcement actions. We offer ongoing strategic advice and counseling, from both offense and defense perspectives, on regulatory exclusivities and other complex issues arising under Hatch-Waxman, the Biologics Price Competition and Innovation Act (BPCIA), and the Orphan Drug Act.
Particularly valuable to over-the-counter (OTC) drug, food, dietary supplement, and cosmetic companies, our attorneys provide regulatory counseling on product development and regulatory requirements, applicable monographs, ingredients, labeling, claims, corporate due diligence, and related corporate agreements.
In addition to our regulatory strategic advice and counseling, we possess significant and relevant experience with regulatory advocacy, including participating in notice-and-comment rulemaking and the development of FDA guidance documents, as well as submitting and responding to Citizen Petitions. We closely monitor and advise our clients on state and federal legislative initiatives that affect FDA-regulated industries.