many intellectual property issues related to drugs for rare and neglected diseases remain. Bond concluded that a full workshop or study on this topic alone would be valuable.

  • Designated orphan drugs—As noted by Coté (see Chapter 3), there have been over 1,850 orphan designations and 326 orphan drug approvals, leaving 1,525 orphan drugs in development or abandoned for various scientific or business reasons. Some of these compounds may still hold promise, and an assessment of their current disposition is needed. Bond suggested as a further area for discussion policies applied to the review of orphan drugs and what new or revised policies might facilitate the approval of such drugs.

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