— 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)
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.