Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 24 November 2020 | By Michael Mezher
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.
Tags: FDA, orphan drugs, pharmaceuticals, US