Can I read MUMS Drug Designation Procedures on EtoBox?

MUMS Drug Designation Procedures by Gern4 is a document available to read on EtoBox.

What is MUMS Drug Designation Procedures about?

This document outlines regulations regarding insufficient quantities of drugs designated as Minor Use and Minor Species (MUMS) drugs. It states that if the FDA believes a sponsor may not be able to ensure sufficient quantities of a MUMS drug, the sponsor must either provide information on how they will ensure quantities or consent to approval of other applications for the same drug. If the sponsor does not address the insufficiency, the FDA can terminate the MUMS designation and exclusive marketing rights.

Author

Gern4

Language

EN