NAPSR/CNPR Exam

NAPSR/CNPR Exam 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)