Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. - Ans✅ True Average review time for a new drug - Ans✅ 18 months Sales Team - Ans✅ Pg 7 The "engine of innovation," focused on discovering or inventing promising new product. - Ans✅ Research & Development This includes supply chain, manufacturing, trade, and distribution functions of the business. - Ans✅ Manufacturing & Operations In 2012, FDA regulators approved 39 new drugs for use in the U.S. - Ans✅ True 3,070 new meds are in development for cancer. - Ans✅ True Define Off-label - Ans✅ Usage of a medication for purposes other than the specific ones appearing on the label Toxicity - Ans✅ The extent, quality, or degree to which a substance is poisonous or harmful to the body Institutional review Board (IRB) - Ans✅ 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 - Ans✅ Inactive pill, liquid, or powder that has no treatment value aka sugar pill