FDA Qualified Infectious Disease Product Designations
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Qualified Infectious Disease Product Designation was introduced in 2012 as a provision of the FDA Safety and Innovation Act to encourage development of treatments for serious or life-threatening infections caused by bacteria or fungi.
You may also be interested in...
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
WHO Launches Twin-Track Procedure To Speed Access To Health Products
A procedure used to accelerate the approval of COVID-19 products during the pandemic is to be applied to all medicines using “synchronized and parallel, but otherwise entirely independent, processes,” the World Health Organization says.
England’s NICE Says No To Santhera’s DMD Drug Agamree Due To ‘Unreliable Modeling’
Santhera Pharmaceuticals did not provide enough evidence to demonstrate that its Duchenne muscular dystrophy drug Agamree was a cost-effective use of resources, according to draft guidance from England’s health technology assessment body, NICE.