FDA Will Require Sponsors to File Promotional Materials Electronically for Fast-Track Drugs

Sponsors who submit drugs or biologics through the FDA’s accelerated programs will have to submit all their promotional materials in advance electronically beginning in 2021, the agency says in final guidance.

Drugmakers are currently obliged to submit labeling and ads to regulators within 120 days of a drug’s marketing approval and at least 30 days before launching the ads or labels. Under the new guidance issued Friday, the FDA says that all submissions for drugs that go through accelerated approvals will have to be made electronically 24 months from now.

The guidance covers submissions made to CDER’s Office of Prescriptions Drug Promotion and CBER’s Advertising and Promotional labeling branch. It also deals with types of promotional materials that are not subject to the mandatory electronic submission requirement.