eCTD Ad-Promo Submissions – Compliance Best Practices

As you know, on June 24, 2019, FDA published the Final Guidance titled “Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs”. The guidance indicates a provision of 24-month notice period beyond which all required submissions must be made in the eCTD format only. Basis the same, submissions of promotional labeling and advertising materials for human prescription drugs in eCTD format will be mandatory starting June 24, 2021. To ensure every firm has its processes in shape before the cut-off date in June 2021, Freyr brings in a comprehensive webinar – ‘eCTD Ad-Promo Submissions – Compliance Best Practices’ - that discusses about common eCTD submission errors and the best practices to avoid them. The webinar is scheduled to be held on June 9, 2021, and it will be hosted by Christopher Campbell, Client Partner at Freyr while James Hormann aka. Jim Hormann, VP RIMS will be presenting the session. For America & EU, you can join us around 10:00 AM CDT.