Posts Tagged ‘Food and Drug Administration’
In a letter to the Chairman and Ranking Member of the United States Senate Committee on Health, Education, Labor and Pensions (HELP), the Sarcoma Foundation of America (SFA) expressed support for the nomination of Scott Gottlieb, MD, for Commissioner of the Food and Drug Administration. In the letter, the SFA urged for the conformation of Dr. Gotlieb, writing that “Dr. Gottleib has an exemplary track record of supporting and spearheading efforts to ensure that safe and effective treatments are moved through the review process in an expedient manner. During his tenure as the Deputy Commissioner for Medical and Scientific Affairs at… Read More »
Today’s post was written by Bert E. Thomas IV, PhD, MBA, CEO of the Sarcoma Foundation of America. Over the past few weeks we’ve seen the Food and Drug Administration (FDA) make decisions regarding some investigational therapies for sarcoma. In that time, one investigational new drug received priority review status, which cuts the drug review period from 10 months to six months. Another was given fast track designation. This designation is also intended to expedited the review process for “serious conditions with unmet medical need.” Certainly sarcoma falls into that category. The Sarcoma Foundation of America (SFA) has long been… Read More »
-Drug Approved for Use in Treatment of Advanced Liposarcoma and Leiomyosarcoma- DAMASCUS, Md. – October 23, 2015 – The Sarcoma Foundation of America (SFA) applauds the announcement by the Food and Drug Administration (FDA) that the drug Yondelis (trabectedin, marketed by Janssen) has been approved by the agency for the treatment of advanced liposarcoma and leiomyosarcoma, two subtypes of soft tissue sarcoma. Yondelis has received approval for the use in the treatment of patients with unresectable or metastatic liposarcoma and leiomyosarcoma who have previously received an anthracycline chemotherapy. “The Sarcoma Foundation of America is thrilled with the FDA’s decision to approve… Read More »