Project Optimus, aims to address these challenges and develop new strategies to reevaluate dosing strategies and reform dose optimization of oncology drugs. This program shifts from the traditional approach to more of a dose-finding approach, considering both therapeutic effects and toxicity effects.
Project Livin’ Label is an educational initiative where using product labeling as a guide, the FDA’s Oncology Center of Excellence (OCE) will moderate the panel discussion – between a FDA reviewer, a clinical trial investigator, a patient who has used the therapy, and a representative from the company that developed the drug. Together, they delve into the journey of the oncology product from development to approval.
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