FDA Wants Male Patients Factored Into Breast Cancer Drug Development

Aug 21, 2019 – The FDA is hoping to improve the armamentarium for male patients with breast cancer through the issuance of industry guidelines aimed at encouraging the inclusion of male patients in breast cancer clinical trials. The industry guidelines, which are still in draft form, pertain to the development and labeling of cancer treatments regulated by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). When … (leggi tutto)