FDA Guidances & Pilot Programs on Oncology Clinical Trials

FDA Guidances & Pilot Programs on Oncology Clinical Trials

This presentation focuses on recent innovations in Oncology Clinical Trials design and the Oncology NDA approval process. In October 2018, the FDA released several new Guidances, including one which covers the use of Minimal Residual Disease (MRD) in clinical trials for hematological malignancies, and another regarding clinical trials for rare genetic variants of a disease. The FDA also began two new pilot programs to increase the efficiency of the NDA process, the Real Time Oncology Review (RTOR) Pilot Program which allows for submission of data prior to submission of a complete NDA, and the Assessment Aid Pilot Program which provides a template for NDA submissions.

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