Comments of the National Research Center for Women & Families and the Cancer Prevention and Treatment Fund on FDA Safety and Innovation Act Section 907 Report -

The National Research Center for Women & Families strongly supports the requirement of the Food and Drug Administration Safety and Innovation Act (FDASIA) for an action plan to include demographic subgroups in clinical trials and data analysis. Greater diversity in clinical trials, analyzing subgroup data, and reporting the results and explaining the implications in product labels and MedGuides will shed light on which medical products are safe and effective for which demographic subgroups, including racial and ethnic minorities.

Testimony of Dr. Jennifer Yttri at FDA Advisory Committee on tivozanib -

Patients with kidney cancer have many options for drug therapy but often experience bad side effects. As the FDA considers another drug option, we don’t think the science is good enough to suggest patients will have a longer and better quality life on this new drug. Instead, we recommend waiting for more clinical data to give doctors and patients a clear idea of when tivozanib would be beneficial rather than cause more harm.