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Dykema

M. Mark Mansour

M. Mark Mansour

Member

WSG Practice Industries

Activity

Dykema
D.C., U.S.A.

Profile

Mark Mansour is a Member in Dykema's Washington, D.C. office. Mr. Mansour has practiced food and drug law for more than two decades, securing FDA approvals for drugs and devices, reviewing drug and device advertising materials, responding to drug, device and food safety issues, and managing recalls. He counsels U.S. and multinational clients on market access, food and nutrition policy, biotechnology, nanotechnology, dietary supplement regulation, agribusiness, and the regulation of cannabis products at the state and federal levels. 

Mr. Mansour has long experience working with clients to resolve advertising matters involving the National Advertising Division of the Council of Better Business Bureaus and the Federal Trade Commission (FTC). He advises clients on social media regulation and has revised numerous corporate websites to ensure compliance with FTC requirements.

He is a member of the ABA Life Sciences Committee and the D.C. Bar regulatory committee, where he has participated in numerous events, discussing issues involving medical devices, pharmaceuticals and biotech. In addition, Mr. Mansour has given numerous speeches, webinars and written materials for the Food and Drug Law Institute (FDLI), which is the pre-eminent organization representing the food, drug and device bar. 

Mr. Mansour previously served as in-house counsel with two major multinational food companies. He is known for his innovative, practical approaches to problem solving, as well as his strong client relations skills. He received his BS from Georgetown University, an MA from Harvard University, and his law degree from Georgetown University. He is admitted to practice law in the District of Columbia and Michigan. 

Bar Admissions

District of Columbia

Michigan

Education

Georgetown University Law Center, J.D. Harvard University, M.A.
  • International Politics
Georgetown University Walsh School of Foreign Service, B.S.
  • International Relations and Affairs
Areas of Practice

Administrative Law & Regulation | Biotechnology and Life Science | Cannabis Law | FDA Regulatory | Product Safety

Articles

Could This Little-Used FDA Submission Process Help Secure Approval for Your Medical Device?
Dykema, February 2021

The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code...

What Changes Are in Store for the FDA Under the Biden Administration?
Dykema, January 2021

A change in administrations from Republican to Democratic usually ushers in increased enforcement, regulation and strategic initiatives. Most of the Trump regulations and initiatives will likely be scrapped where possible. They will be replaced by rules and guidance documents that have been held in abeyance during the previous administration, as well as numerous new initiatives...

WSG's members are independent firms and are not affiliated in the joint practice of professional services. Each member exercises its own individual judgments on all client matters.

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