Area of focus

Advertising and Promotion Compliance

Our lawyers help companies balance legal compliance with their business objectives helping them to navigate the current environment, highlighted by evolving U.S. Food and Drug Administration (FDA) and EU Member States laws. From regulations and policies governing medical device labeling, advertising and promotion; to the...

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Representative experience

Conduct internal investigations of promotional practices.

Conduct one-off reviews or wholesale audits of promotional materials and activities on traditional and alternative media platforms.

Sit on clients’ standing promotional review committees (PRCs).

Conduct salesforce trainings on FDA requirements and expectations with respect to advertising and promotion.

Conduct advertising and promotional trainings for every size of device firm, and for every level within these firms, from C-suite to sales representatives, to lay the groundwork for effective and compliant marketing.

Work with clients to develop SOPs governing the review and approval of promotional materials.

Counsel clients on the inter-relationships between FDA requirements and health care laws to assist these companies in developing and implementing corporate policies and procedures aimed at compliance.

Conducted a corporate investigation of sales and marketing practices, and advised senior managers and corporate boards on the risks and benefits of strategies and tactics.

Conducted internal investigations and compliance audits to ensure that promotional activities did not violate the Federal Food, Drug, and Cosmetic Act.

Review client websites and sit on Promotional Review Committees to assess regulatory risk from proposed promotional strategies and recommend revisions to mitigate risk in delivering key marketing messages.

Assist clients in assuring compliance with European Union and member state requirements and streamlining U.S. and OUS marketing procedures and practices to ensure global compliance.

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