Most Recent Articles by Da Hee Han
This effort is in response to epinephrine auto-injector supply issues reported by manufacturers to the Food and Drug Administration (FDA).
The Smart Case includes electronics and sensors to monitor the proximity, temperature, presence and removal, and expiration of auto-injectors.
The safety and efficacy of Oxervate was evaluated in 2 independent, double-masked, randomized, multicenter, controlled clinical trials involving patients with moderate to severe neurotrophic keratitis.
The trial will be a Phase 2b dose-ranging study (N=216) with patients from 12-15 research centers across Europe and North America.
This date modification beyond the approved 20-month shelf life was based an FDA review of product stability data submitted by Mylan.