Business · 19/06/2006Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance on Review and Inspection of Premarket Approval Application Manufacturing Information
Summary
The FDA is releasing a draft guidance document to help manufacturers prepare for FDA's review of their premarket approval application manufacturing section and preapproval inspection of manufacturing operations, as part of its commitment to improve scheduling and timeliness of preapproval inspections.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →