![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Merck Scores Breakthrough Designation, PRIME Status for Ebola Vaccine
Merck Scores Breakthrough Designation, PRIME Status for Ebola Vaccine
July 27, 2016
Merck landed a double win, garnering a breakthrough designation from the FDA and PRIME status from the European Medicines Agency for its investigational vaccine Ebola Zaire, designated as V920.
During the latter half of 2014, Merck licensed the candidate from NewLink Genetics.
Launched in March, the EMA’s Priority Medicines is an initiative to fast-track breakthrough therapies by engaging sponsors sooner to provide drug development guidance and help companies develop clinical trial designs.
Upcoming Events
-
21Oct