Common FDA, EMA Guidance on Orphan Drug Protocol Needed, Experts Say

To help drugmakers speed new therapies to patients with rare diseases, U.S. and EU regulators should harmonize their philosophies around orphan drug protocol and generate common guidance, experts say. Harmonizing regulations, on the other hand, would be too big an exercise and not necessarily helpful, according to Yann Le Cam, CEO of patient-group alliance EURODIS.
Drug Industry Daily