Home » Harmonizing U.S., EU Orphan Protocol Guidance Could Speed Access to Therapies
Harmonizing U.S., EU Orphan Protocol Guidance Could Speed Access to Therapies
To help drugmakers speed new therapies to patients with rare diseases, U.S. and EU regulators should harmonize their philosophies around orphan drug development and generate common guidance on trial requirements, 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. But “it would be helpful if there were common guidelines between the FDA [U.S. Food and Drug Administration] and the EMA [European Medicines Agency] on some diseases or groups of diseases to help drugmakers identify which are the best clinical trial designs,” Le Cam said.
International Pharmaceutical Regulatory Monitor
International Pharmaceutical Regulatory Monitor
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