Expertise in all things FDA
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Expertise in all things FDA
Overview
Dara Levy helps pharmaceutical and medical device companies on a wide range of issues relating to product communications, marketing, and import/export. Dara assists clients with products in all stages of development to design engaging communications compliant with FDA legal and regulatory requirements.
In the pre-marketing stage, Dara works with companies to strategically communicate with investors, potential marketing partners, and the scientific community, as well as implement effective disease awareness initiatives. At launch and in the post-marketing stage/environment, Dara works closely with corporate communications and marketing departments to help achieve their goals.
Dara serves as the legal reviewer on promotional review committees for branded products. Clients range from small start-ups to global Fortune 500 companies.
Dara has assisted on products ranging from orphan drugs to blockbuster pharmaceuticals, providing key support for successful launch campaigns, new marketing initiatives, social media and digital tactics, television advertisements and traditional healthcare professional and direct-to-consumer materials. Dara also conducts company training programs on implementing effective promotional review procedures.
In the import/export area, Dara advises and represents U.S. and foreign-based companies before FDA on a range of issues including interpretations and appropriate responses to FDA Notices of Action, establishment registration and product listings, import for export, country of origin determinations, export certificates, and export of unapproved products.
Prior to joining the firm in 2001, Dara practiced in the Washington D.C. office of a major international law firm focusing on complex product liability litigation. Dara also worked on the Regulatory Staff of the Center for Devices and Radiological Health (CDRH).