off label use 예문

• The legislation also lets companies present scientific evidence showing how a drug approved to treat one malady can be prescribed to treat anotherillness _ a practice known as " off label use ."
• The use of cholinergic adjunctive medications is uncommon and their clinical effects are poorly researched; consequently, cholinergics such as galantamine or varenicline would be off label use for ADHD . New ABT-894.
• In the United States, when a test article is unapproved or not yet cleared by the Food and Drug Administration ( FDA ), or when an approved or cleared test article is used in a way that may significantly increase the risks ( or decreases the acceptability of the risks ), the data obtained from the pre-clinical studies or other supporting evidence, case studies of off label use, etc . are submitted in support of an Investigational New Drug ( IND ) application to the FDA for review prior to conducting studies that involve even one human and a test article if the results are intended to be submitted to or held for inspection by the FDA at any time in the future ( in the case of an already approved test article, if intended to submit or hold for inspection by the FDA in support of a change in labeling or advertising ).