Orphan Designation Requests To Get Slower US FDA Reviews

The US Food and Drug Administration has extended its deadline for delivering an orphan drug designation decision, placing more pressure on sponsors to ensure requests contain no problems from the start.

The US Food and Drug Administration has extended its deadline for delivering an orphan drug designation decision, placing more pressure on sponsors to ensure requests contain no problems from the start.

FDA's Office of Orphan Products Development now hopes to decide whether a product is eligible for orphan drug incentives in...

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