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Reforming FDA: Focus on safety, let market judge efficacy

s because the safety and efficacy studies used in obtaining initial approval are generally pertinent only to very defined and limited indications. Indeed, as efficacy endpoints become even more of a challenge to achieve, limiting the scope of primary indications becomes increasingly necessary. Thus, safety information obtained as part of an application may not be relevant for unregulated off-label......

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Source:wistechnology.com By Ogan Gurel 06/25/07


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