FDA to Require Drugs Promotion Submissions in eCTD Format

The FDA plans to discontinue accepting paper submissions from drugmakers submitting promotional materials for prescription drugs and offers guidance on how to submit such information using the electronic common technical document.

The draft guidance released last week outlines the kinds of content to include for specific types of submissions, such as presubmission of promotional materials for accelerated approval products, promotional materials submitted to fulfill postmarketing reporting requirements and promotional materials submitted voluntarily for advisory comments. It also provides the required format for hard-copy submissions that firms may use in the 24 months leading up to the eSubmission deadline.

The guidance covers a wide array of promotional materials including, but not limited to, television ads, brochures, booklets, Internet sites, print and radio ads and sound recordings.

Once the guidance is finalized, companies will have two years to stop submitting hard copies of their materials.

“Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising for Human Prescription Drugs Guidance for Industry,” can be found at www.fdanews.com/04-22-15-compliance.pdf. — Anne Pavuk Wright