Business · 28/05/2024Updated: 10/17/2026 · 1 min read
FDA Proposes to Withdraw Approval of Four New Drug Applications Amid Repeated Non-Compliance
Summary
The FDA is proposing to withdraw approval of four new drug applications after NDA holders repeatedly failed to file required annual reports, and is offering NDA holders the opportunity to request a hearing on the proposal.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →