Starting June 24th, 2021, the US FDA will require all your post-marketing submissions of promotional materials and submissions of promotional materials for accelerated approval products be submitted via electronic Common Technical Document (eCTD) format. The 37-page guidance by the FDA titled, “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs” defines ‘FDA-required labeling’ as any labeling reviewed and approved by FDA as part of the marketing application review process. Whether it’s your website, television advertisements, exhibits, product brochures, print adverts, etc., make sure you are prepared June 24th to successfully submit your promotional submissions and avoid common eCTD formatting errors. Certara’s regulatory operations experts explain the need-to-know information for providing your promotional materials submissions in the eCTD format to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling branch (APLB) in the Center for Biologics Evaluation and Research (CBER).
Rob Labriola, Senior Director Regulatory Services, Certara Synchrogenix
Robert Labriola has over 25 years of experience in the pharmaceutical industry, with a focus on regulatory operations. His areas of expertise include leading global regulatory submission projects, building regulatory operations teams, and implementing document management/electronic submissions solutions. Mr. Labriola has been involved in the production of electronic regulatory submissions to numerous health agencies, with experience in all roles and at all leadership levels, and has directed numerous multi-company regulatory submissions for investigational and marketing applications. Mr. Labriola was an early adopter of the electronic Common Technical Document (eCTD), serving on industry regulatory technology working groups with Bio and PhRMA. He has served as a mentor and speaker to undergraduate and postgraduate students seeking life science careers and holds a Master of Science in Regulatory Affairs and Clinical Research Management. Mr. Labriola provides regulatory operations strategy, consulting, and submission support to Certara Synchrogenix clients, delivering quality services that drive clients to achieve their goals.
Rachel Bombara, Sr. Regulatory Operations Specialist, Certara Synchrogenix
Rachel Bombara is a seasoned submission lead and publisher with a decade of experience in Regulatory Operations and helping clients achieve their submission goals. From small amendments to large-scale original marketing applications, she has worked with clients on a variety of different submission types, and ensured deliverables to health authorities are timely, of a high quality, and pass technical validation. Preparing promotional material submissions in eCTD and transmitting them via the FDA ESG is a service she regularly provides to clients.