Consulting Services

FDA regulatory review of professional and direct-to-consumer (DTC) promotional materials and other external corporate communications

— Strategic advice in the development of product labeling and associated "launch" campaigns

— Interactions with FDA's Office of Prescription Drug Promotion (OPDP, formerly DDMAC), including the preparation of “preclearance” submissions for advisory comment

— Creation, development and revision of corporate policies and SOPs relating to promotional and corporate communications

— Audit and risk assessment of existing practices and materials

— Customized training on FDA/OPDP requirements, including advanced topics (e.g., claims substantiation, internet & social media)

The Approach

John brings a creative, collaborative, solutions-oriented approach to his work, helping key stakeholders successfully navigate FDA requirements.

Experience & Education

Prior to his move into consulting, John worked for over 10 years in regulatory affairs at several biopharmaceutical companies, primarily in the area of advertising & promotion compliance.  

John has a B.A. from Harvard University.