Business · 18/11/2019Updated: 10/17/2026 · 1 min read

Pan American Laboratories, LLC, et al. Seek FDA Hearing on Withdrawal of Four New Drug Applications

Summary

The FDA is proposing to withdraw approval of four new drug applications from multiple holders due to repeated failure to submit required annual reports, and is offering NDA holders the chance to request a hearing on this proposal

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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