Business · 03/11/2003Updated: 10/17/2026 · 1 min read

FDA Releases Guidance for Industry on Premarket Approval Application Modular Review

The Food and Drug Administration (FDA) has made available a new guidance document, titled 'Premarket Approval Application Modular Review,' which outlines the agency's process for reviewing premarket approval applications (PMAs) in a modular format, providing industry and FDA staff with essential information on this program.