Genmab — November 2018
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7 uger? Det jeg kan se er at sgen fik godkendelse 2 uger efter færdiggørelsen af ansøgningen. I den skematiske tidsplan her er det så 2 uger efter uge 16. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612927.htm
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The new process, known as the Real-Time Oncology Review (RTOR) program, allows the agency to access key data prior to the official submission of the application, the FDA explained in a press release.This allows the review team "to begin their review earlier and communicate with the sponsor prior to the application's actual submission," said Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology
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