Tag: expedited pathways


Navigating Expedited Regulatory Pathways in the U.S. and Europe

Breakthrough therapy designation in the U.S. and PRIority MEdicines (PRIME) in the EU are two programs intended to facilitate and expedite development and review of new drugs to address unmet medical needs. By successfully engaging with regulatory authorities early in the clinical development process, sponsors of eligible investigational drugs can help ensure that their development...

Medical and Regulatory Affairs

What’s Ahead in Orphan Drugs? Attend Our June 1 Webinar

DURHAM, N.C., May 31, 2016 — Treatment of rare indications is turning a promising corner as regulators and lawmakers boost incentives and guidance in these areas of unmet medical need. Three experts from Premier Research will look at financial aid, expedited reviews, and other avenues available to orphan drug developers in a webinar on Wednesday, June...