Business · 26/03/1999Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance on Accelerated Approval Products: Submission of Promotional Materials
Summary
The Food and Drug Administration (FDA) has released a draft guidance for industry on accelerated approval products, outlining the submission requirements for promotional materials, including labeling and advertisements, within 120 days of marketing approval.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →