The peri-approval period between completion of registration trials and FDA approval of a new cancer medicine presents a “window of opportunity” for conducting dose comparison studies, a multi-stakeholder panel said Nov. 7 at the 2013 Conference on Clinical Cancer Research.
Conducting further dose exploration as part of an expanded access program before drug approval could lead to better information in labeling about the appropriate dose without unduly delaying a drug’s approval. It could also give sponsors an opportunity to improve the competitiveness of their product or extend the length of time that a patient can take a drug by identifying more tolerable regimens or dose modification schedules, according to an
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