Section 506Fast Track Products

To facilitate the development and to expedite the review of a drug product for the treatment of a serious or life-threatening condition where the product demonstrates the potential to address unmet medical needs for the condition, Section 506 addresses this situation. The fast track approval of such a product can be based on the determination that the product has an effect on a clinical endpoint or on a surrogate endpoint that is reasonably likely to predict clinical benefit. However, the approval of a fast track product may be subject to a requirement that the sponsor conduct appropriate postapproval studies to validate the surrogate endpoint or otherwise confirm the effect on the clinical endpoint within a specified time.

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