December 2013. When Eddie Creed died at the Veterans Affairs hospital on Beacon Hill last year, his death certificate said throat cancer had killed him. But a KUOW investigation reveals what his doctors knew: A medical device called an Infusomat, which had been recalled the month before, ended his life. “Sadly, we actually have much more access to information about defective toasters, and certainly defective cars, than we seem to about defective medical devices,” said Diana Zuckerman, who heads the National Research Center for Women and Families in Washington, D.C.
Thank you for the opportunity to speak today on behalf of the Cancer Prevention and Treatment Fund. My name is Dr. Anna Mazzucco, and after completing my Ph.D. in Cell and Developmental Biology from HarvardMedicalSchool I conducted research at the National Cancer Institute. I bring those perspectives today.
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.