Navigating the FDA Real-Time Oncology Review Process for Sponsors

Started in 2018, the FDA’s “Real-Time Oncology Review (ROTR)” project gives sponsors a head start on the application review process and poses additional challenges. The ROTR helps sponsors plan around anticipated FDA results immediately to begin preparing their full submission package early. This program has supported the approval process of numerous applications for oncology. However, It may add additional burden to the FDA and uncertainty to application sponsors regarding requirements.

According to Angelo Tinazzi of Cytel, “Given the fact the first version of these specifications was released on July 2019, with current version updated last February (from their revision history “Modified several variable names for CDISC compliance; added notes for some OOD-specific variables”), it is not known if the sponsors that have shared their experience so far have followed the suggested ADaM structure and how much FDA was flexible receiving something different.”

Read Tinazzi’s entire article by clicking here.

(Source: Cytel, November 30^th, 2021)