Business · 09/01/2020Updated: 10/17/2026 · 1 min read
Fresenius USA, Inc., et al.; Withdrawal of FDA Approval for 249 Abbreviated New Drug Applications: Opportunity for Hearing
Summary
The FDA is proposing to withdraw approval of 249 abbreviated new drug applications from multiple holders due to repeated failure to file required annual reports, and is offering a hearing to those affected parties.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →