The US FDA’s Real-Time Oncology Review (RTOR) pilot program has required participating sponsors to change how they prepare and submit supplemental applications, but these challenges have come with some big payoffs, including greater certainty about application acceptance and review times that can be counted in days and weeks, as opposed to months.
Real-Time Oncology Review Has Sponsors Rethinking What Data To Share With US FDA And When
Pilot program that gives agency early look at pivotal data has forced sponsors to change how they go about preparing supplemental applications; potential expansion to new molecular entities would bring new challenges, including need to align manufacturing and clinical site inspections with expedited review timeline.
More from Review Pathways
• By
The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.
• By
Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
• By
The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
• By
Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
More from Pathways & Standards
• By
Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
• By
The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
• By
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.