Getting Started with Electronic Submissions for Promotional Materials
In 2015 the U.S. Food and Drug Administration (FDA) began accepting electronic submissions for drug promotional labeling and advertising (AdPromo). But in 2017 — a date not that far off — submitting both drug and biologic AdPromo submissions digitally will become not just optional, but mandatory.
Yet many sponsors have delayed the move to electronic Common Technical Document (eCTD) submissions. While the reasons for postponing are understandable, the reasons for being proactive are even more compelling. To help drug sponsors get started, CSC now offers next-generation AdPromo services and solutions.
CSC offers a five-step process that clients can choose from, based on their level of compliance in meeting the FDA’s submission requirement. Following these steps to upgrade to the new Module 1 requirements will give your company the ability to send AdPromo submissions electronically, leveraging the new granularity of both the FDA’s Office of Prescription Drugs Promotion and the Advertising and Promotional Labeling Branch.
- Systems Upgrades
- Process Development