hitt on tour

health & around thoughts, on the fly & on the flight

ISPOR 20th annual European congress

Dr. Sola Morales will discuss about the topic that in 1999, the EU enacted legislation to foster the introduction of new Orphan Medicinal Products (OMP) into the market. To date only partial evaluations of the success of this legislation have been made, so this analysis investigates the outcomes of the OMP legislation from a broader perspective.

FDA clinical trials

In the past months we’ve seen the approval of several drugs with limited data. Possibly this is the ‘natural’ consequence of both the Fast Track Designation and the Adaptative Pathway solutions that have been accepted.