Business · 29/12/1999Updated: 10/17/2026 · 1 min read
FDA Announces OMB Approval for Guidance on NDA/ANDA Changes
Summary
The Food and Drug Administration (FDA) has announced that it has received approval from the Office of Management and Budget (OMB) for a new guidance document related to changes to approved New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs), as required by the Paperwork Reduction Act of 1995.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →