NAPSRx/CNPR Study Guide-Latest Update

The FDA regulates the introduction of new drugs and enforces U.S. drug laws. - True Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. - True Average review time for a new drug - 18 months Sales Team - Pg 7 The "engine of innovation," focused on discovering or inventing promising new product. - Research & Development This includes supply chain, manufacturing, trade, and distribution functions of the business. - Manufacturing & Operations In 2012, FDA regulators approved 39 new drugs for use in the U.S. - True 3,070 new meds are in development for cancer. - True Define Off-label - Usage of a medication for purposes other than the specific ones appearing on the label Toxicity - The extent, quality, or degree to which a substance is poisonous or harmful to the body Institutional review Board (IRB) - A committee of physicians, staticians, community advocated, and others which ensure that a clinical trial is ethical and that the rights of the study participants are protected. All clinical trials must be approved by an IRB before they begin. Placebo - Inactive pill, liquid, or powder that has no treatment value aka sugar pill Edema - Swelling Asymptomatic - Without signs or symptoms Clinical Pharmacology - The study of the effects and movement of drugs in the human body Anatomy - The study of basic structures of the body Physiology - The study of how those body structures function