New Guidance Documents: Inclusion of Adolescent Patients in Adult Oncology Clinical Trials/ Assessment of Pressor Effects of Drugs

New Guidance Documents: Inclusion of Adolescent Patients in Adult Oncology Clinical Trials/ Assessment of Pressor Effects of Drugs 1. Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials Guidance for Industry The purpose of this guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards (IRBs) with information to facilitate the inclusion of adolescent patients (for purposes of this guidance defined as ages 12 to 17) in relevant adult oncology clinical trials. FDA recommends the inclusion of adolescents in disease- and target-appropriate adult oncology trials to enable earlier access to investigational and approved drugs for adolescent patients with cancer. 2. Assessment of Pressor Effects of Drugs Guidance for Industry The purpose of this guidance is to advise sponsors on the premarketing assessment of a drug’s effect on blood pressure. Elevated blood pressure is known to increase the risk of stroke, heart attack, and death. The effect of a drug on blood pressure can therefore be an important consideration in benefit-risk assessment.