FDA in Brief: FDA encourages inclusion of male patients in breast cancer clinical trials | FDA

FDA in Brief: FDA encourages inclusion of male patients in breast cancer clinical trials | FDA

FDA in Brief: FDA encourages inclusion of male patients in breast cancer clinical trials

The draft guidance, Male Breast Cancer: Developing Drugs for Treatment, includes draft recommendations for inclusion of males in breast cancer clinical trials. Historically, males either have not been included in clinical trials for drugs to treat breast cancer or inclusion of males in those trials has been very limited; when finalized, the draft guidance will provide clarity for industry regarding clinical development of drugs to treat breast cancer in male patients.

Read More