Advocacy With FDA
Our great relationships at FDA do not get in the way of our advocacy. If you need representation during an FDA meeting, we are there for you. We know how to work with FDA diplomatically and respectfully. We appreciate the job which FDA must do, and most of the time they are very good at it. We also recognize that FDA often does not strictly follow the "rules" which should govern their conduct and decision-making, and sometimes they need to be challenged. We enjoy our relationships with FDA, but our relationships never get in the way of advocating for our client’s position, to ensure that our clients get the best and most expeditious result possible. We are good at negotiating with FDA.
We are involved in meetings and appeals of all kinds. We assist clients with difficult or intractable FDA investigators. We also attend local District Office meetings to meet with the District Director on inspectional or enforcement matters. Our specialty is taking clients to the Center in Silver Spring, Maryland for meetings of all kinds, including Pre-IND/IDE, Pre-Submission Meetings, informal meetings and formal appeals under 21 C.F.R. 10.75, Part 15 hearings, as well as negotiations on warning letters and other enforcement matters, clinical trials and performance data, 510(k)s, de novos, PMAs, combination products, HDEs, Orphan Drugs and ANDA/NDAs.
We are also involved with enforcement outside of FDA. We also negotiate with the Office of Inspector General (OIG), the Department of Justice (DOJ) and United States Attorneys on investigatory matters and settlements.