Clayton's Basic Pharmacology for Nurses Chapter 1

1983 Orphan Drug Act - This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases. Biologic therapies - Biologic agents are large complex proteins manufactured in living system such as microorganism or within plant or animal cells. Transformed treatment of patients with disorders that attack the body's own organs, tissues, and cells. (autoimmune disorders and hematologic disorders) Biosimilar - Under the BPCI Act, a biological product may be demonstrated to be "biosimilar" if data show, among other things, the product is "highly similar" to an already-approved biological product. black box warning - A type of warning that appears in a drug's prescribing information and is required by the U.S. Food and Drug Administration (FDA) to alert prescribers of serious adverse events that have occurred with the given drug. brand-name drug - a drug with a registered name or trademark given to a drug by a pharmaceutical company chemical name of drug - - scientific name that precisely describes drug's atomic & molecular structure Controlled Substances Act of 1970 - a federal statute that regulates the manufacture and distribution of the drugs that are capable of causing dependency.