Research and Development
We work closely with our clients from the earliest stage of a product’s life cycle – research and development. Our firm’s work representing academic medical centers, research institutes and universities, in addition to global life sciences companies, gives us a wide range of experience and perspective from which to draw when counseling clients on clinical research and development activities. We regularly counsel FDA-regulated companies that sponsor product research on compliance with federal laws relating to clinical research, including FDA investigational new drug and investigational device exemption requirements, human subjects protections, adverse event reporting, clinical trial registration and results reporting, privacy laws, conflicts of interest, and the proper use of federal research funds. We help clinical sites and research sponsors develop and implement research policies, procedures and templates to ensure compliance with legal requirements, protect business interests and facilitate research activities.
Obtaining FDA approval or clearance to market drugs, biologics, medical devices and food additives – especially those that have encountered difficulties in the approval process – requires experienced counsel. We regularly advise clients on such matters, from the initial development of regulatory approval strategies through implementation of those strategies, including preparing for and participating in advisory committee proceedings, responding to difficult questions from the FDA and appealing adverse decisions.
Competitor Market Entry
Strategic business and legal advice is essential on statutory provisions that confer exclusive marketing rights on qualifying products, including the Hatch-Waxman Act, the Orphan Drug Act, the pediatric exclusivity provisions of the Federal Food, Drug & Cosmetic Act, and the Biologics Price Competition and Innovation Act. We are one of the few firms that combines a top-ranked FDA counseling practice with highly regarded Patent Strategy and IP litigation practices. This combination of skills and experience gives us an unsurpassed understanding of the relationship between patent and nonpatent exclusivity rights.