Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms investigational drug and investigational new drug are deemed to be synonymous for purposes of this part.b) The availability for public disclosure of all data and information in an investigational new drug application for a new drug will be handled in accordance with the provisions established in 314.430 for the confidentiality of data and information in applications submitted in part 314.
Pulmonary arterial hypertension (PAH) is a rare, progressive disorder characterized by high blood pressure (hypertension) in the arteries of the lungs (pulmonary artery) for no apparent reason. The pulmonary arteries are the blood vessels that carry blood from the right side of the heart through the lungs.
Patients with CTEPH and these abnormalities are uniquely identified as Group 4 in the Dana Point classification of pulmonary hypertension. Integrated approach to management Mayo Clinic provides an integrated approach to the management of patients with pulmonary hypertension. The Pulmonary Hypertension Clinic at Mayo Clinic in Rochester, Minnesota, is staffed by cardiologists, pulmonologists, interventional radiologists and cardiothoracic surgeons with expertise in the diagnosis and treatment of CTEPH.