At Haug Partners, we combine a wealth of government and industry experience with technical and legal expertise to provide exceptional FDA regulatory representation and counseling. Our FDA, patent, and antitrust attorneys work closely together to provide seamless interdisciplinary counseling to clients in the biopharmaceutical, biotechnology, and medical device industries.
For decades, we have helped shepherd our clients through complex regulatory and administrative procedures in diverse FDA proceedings. We have advised clients on requirements for products with complex bioequivalence profiles, such as partial AUC, gastrointestinally-targeted, and narrow therapeutic index products, and on requirements for generic sameness. Our FDA team has worked extensively with both generic and branded pharmaceutical companies to devise regulatory strategies, including by clearing regulatory hurdles prior to launch, obtaining regulatory exclusivities, shaping drug policies and competitive landscapes through Citizen Petitions, and providing counseling under the Orphan Drug Act, the Biosimilar Price Competition and Innovation Act, and the Hatch-Waxman Act and related sections of the Federal Food, Drug, and Cosmetic Act.