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FDA launches online orphan submissions portal

Posted 24 November 2020 | By Michael Mezher 

FDA launches online orphan submissions portal

The US Food and Drug Administration (FDA) on Monday launched a new cloud-based submission portal for orphan drug designation requests, shifting away from the current paper and CD-based submission process.

The new portal, first announced in January, is part of the agency’s orphan drug technology modernization effort and fits in with its broader technology modernization plans. The shift to electronic submissions follows a decade of increasing orphan drug designation requests and orphan drug approvals. (RELATED: FDA to allow online submissions of orphan designation requests, Regulatory Focus 17 January 2020).

“Moving from a paper-based to a cloud-based submission portal provides drug developers with enhanced, direct communication with the FDA regarding each submission. The portal system will help ensure questions are answered and will allow for feedback from sponsors,” FDA writes, noting that the electronic submission pathway is of greater importance than ever amid the COVID-19 pandemic.

Alongside the new submission portal, FDA says it has implemented a new workflow management tool to increase the efficiency of reviews.

“This important initiative is part of broader technology modernization efforts at the FDA to develop a more connected information technology system, advanced analytics and improvements in knowledge management,” said FDA Principal Deputy Commissioner Amy Abernethy.


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