The document outlines the REMS program by William Blair & Company, LLC, which includes a communication plan to educate patients and prescribers about the risks associated with occlusions and the revised indication. It mentions the distribution of letters and fact sheets to healthcare professionals and the evaluation of awareness by the FDA. Additionally, it details four PMRs that Ariad will be held to, focusing on assessing the risk and long-term safety of Idusig and Iclusig treatment.
doj/DataSet10/EFTA01450728.pdf
{"key_people":["Y. Katherine Xu, Ph.D."],"document_type":"correspondence","document_subtype":"memo","key_organizations":["William Blair & Company, LLC","FDA","Ariad"],"reference_numbers":["DB-SDNY-0106553","SDNY_GM_00252737","EFTA01450728"]}