Business · 18/02/2014Updated: 10/17/2026 · 1 min read
FDA Announces Approval of Guidance Document on Postapproval Manufacturing Changes
Summary
The Food and Drug Administration (FDA) has received approval from the Office of Management and Budget (OMB) for a guidance document outlining requirements for documenting postapproval manufacturing changes in annual reports, as mandated by the Paperwork Reduction Act of 1995.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →