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.
Although PAH is not very well known to the general public, everyone one can be exposed to it through many different pathways. Polycyclic Aromatic Hydrocarbons (PAH) are molecules made from carbon and hydrogen. PAH is comes into being when materials are burned, these materials include wood, oil, charcoal and tobacco.PAH is even present in some of our own household products such as mothballs, some shampoos and skin creams.lthough PAH is not very well known to the general public, everyone one can be exposed to it through many different pathways. Polycyclic Aromatic Hydrocarbons (PAH) are molecules made from carbon and hydrogen. PAH is comes into being when materials are burned, these materials include wood, oil, charcoal and tobacco.