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# FDA to Take Longer to Review Orphan Drug Requests
- URL: https://www.fdaweb.com/fda-to-take-longer-to-review-orphan-drug-requests/
- Published: 2016-07-18T12:00:00.000Z
- Updated: 2026-09-14T21:15:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136203

FDA says it will take 33% longer to review orphan drug designation requests due to the growing demand in new submissions. Previously, the agency worked within an internal goal to review 75% of designation requests within 90 days. Now, because of the sustained increase in designation requests over the past three years, the current goal is to review on average 75% of designation requests within 120 days, an Office of Orphan Product Development (OOPD) [notice](http://blogs.fda.gov/fdavoice/index.php/2016/07/the-rise-in-orphan-drug-designations-meeting-the-growing-demand/?ref=fdaweb.com) says.

In 2014, FDA says, orphan drug designation requests saw a 30% increase over the prior year’s record number. In 2015, the agency received even more requests than the previous year. “And the pace does not seem to be slowing,” it says. “In fact, comparing the number of new requests received so far in 2016 with the corresponding date in 2015, there appears to be yet another 30% increase.”

Because of the growing submission rate, FDA says it will continue to evaluate workload in relation to resources, and may need to further adjust review timelines in the future. “Companies can play a critical role in ensuring that the new review timeframe does not translate into a delay in obtaining orphan drug designation by doing their part to reduce the number of review cycles needed (i.e., when OOPD needs additional information from the sponsor prior to determining the outcome of an orphan drug designation request),” it says. “On average, a request for designation today goes through two such review cycles. Sponsors can shorten this process by ensuring that designation requests are complete and fully address all requirements. We recommend sponsors review the information at [www.fda.gov/orphan](http://www.fda.gov/orphan?ref=fdaweb.com) for helpful hints and FAQs when developing their requests.”