Young US FDA Office Of New Drug Policy Faces Regulatory Crucible In COVID-19
Created last year under the Office of New Drugs reorganization, ONDP works to promote regulatory consistency while fostering innovation – and reacting to unexpected challenges like the pandemic.
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Ideally, the system will prevent some cell and gene therapy programs from slowing, CBER Director Peter Marks says.
All NMEs and original BLAs are expected to adhere to the team-based review approach by the end of the year, with expansion to other application types later.
Novel agents approved under Real-Time Oncology Review posted a median time to approval of seven months, our Pink Sheet RTOR infographic shows, while other RTOR applications had a median 4.5 month approval time.