Food and Drug Administration Regulatory Counseling
We regularly work with biomedical companies in determining how their products will be regulated, designing product development strategies to minimize review time, and assisting in optimal presentation of evidence to gain FDA approval or clearance. Our capabilities span the full range of US FDA matters, including developing regulatory strategies for approval or clearance of novel and combination products, advising on FDA-related patent listing and exclusivity matters, navigating the biosimilars framework, counseling on labeling and safety issues, and seeking designations for orphan, breakthrough, accelerated approval, and Qualified Infectious Disease Product status, as well as processing for obtaining priority review vouchers.
Our team has years of experience representing clients in shaping and challenging regulatory agency policies. We have been successful in numerous petitions on behalf of clients asking the FDA to adopt rules protecting the rights of clients, to prevent unlawful approvals or other agency actions, or to reverse decisions adverse to clients' interests. We have also successfully pursued FDA dispute resolution processes, and have sued the FDA to reverse improper agency decisions.