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A plan to eliminate the backlog of existing requests for approval of drugs for rare conditions and speed responses to new requests was announced Thursday by the U.S. Food and Drug Administration.
The so-called orphan designation is typically for drugs used to treat diseases that affect fewer than 200,000 people in the U.S., and orphan designation provides drug makers with incentives such as tax credits for clinical trial costs and a seven-year exclusive patent.
Last week, the FDA committed to eliminating the orphan designation request backlog within 90 days and responding to all new requests within 90 days of receipt. Currently, the FDA has about 200 orphan drug designation requests waiting for review.
The number of requests has increased over the past five years. There were 568 requests in 2016, more than double the number in 2012.
The new plan includes a review team that has significant expertise in orphan drug designation and will focus solely on the backlogged applications, starting with the oldest requests, the FDA said.
It will also implement a new streamlined review template to improve the consistency and efficiency of its reviews.
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