Mark Mansour has more than two decades of experience handling federal Food and Drug Administration (FDA) regulatory matters.
Mark Mansour has no reviews yet! Be the first to leave a review!
Clients call me most frequently in crisis situations. We are focused and effective when things need to be done, and quickly. While we do the other work that characterizes a food, drug and device practice, the difficult situations stand out. We have resolved many of these situations (and saved clients a lot of money in the process). The most rewarding short term aspect is clearing a serious problem off a client's desk. Long term, what I value most is the deep professional and personal friendships I have forged, relationships that often began in a crisis. Sharing a foxhole with a client is a singular experience, and one that makes every day unique.
I have twenty-five years of extensive in-house and private practice experience, developing and implementing domestic and international legal, business, and trade strategies for approval and clearance of FDA regulated products, as well as emerging technologies (such as nanotechnology and biotechnology). We work with our clients to respond to and manage enforcement actions such responses to 483s and Warning Letters, major actions such as recalls and inspections both domestic and international, as well as product detentions and seizures, Import Alerts and consent decrees. In addition, we help our clients navigate the advertising regulations enforced by the FTC.
We help clients solve real-world business problems both domestically and internationally, rather than drafting memoranda and providing legal advice in a vacuum. Our team employs a creative, global approach to regulatory strategy with the objective of helping our clients get on the market and stay there. We work with our internationally acclaimed colleagues in the litigation, appellate, regulatory, government relations, trade, customs, IP, corporate, mergers and acquisitions, antitrust and other key practice areas to provide a true life cycle approach to meeting our clients' legal and business needs.