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International Pharmaceutical Regulatory Monitor
> Harmonizing U.S., EU Orphan Protocol Guidance Could Speed Access to Therapies
International Pharmaceutical Regulatory Monitor
May 2012
| Vol.
40 No.
5
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.
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