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.
November 20, 2013. We welcome the opportunity to comment on the FDA’s guidance to industry on preclinical detection of endocrine disruption potential in drug and biologics applications.
November 2013. We write today to urge the FDA to remove menthol cigarettes from the market as quickly as possible. A conservative modeling scenario published in a peer-reviewed medical journal estimated that over 320,000 deaths could be averted by 2050 had menthol been banned in 2011 as recommended. The FDA must not drag its feet any longer.
We agree with the Task Force that at this point, there is no reason to recommend virtual colonoscopies for most patients who need screening. We would add, however, that if specific patients are unwilling to undergo regular colonoscopies, then a virtual colonoscopy is a reasonable alternative.
All sunlamps should be reclassified as Class III devices because of their known risks, especially the increased likelihood of developing the most serious type of skin cancer.
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.