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The Food and Drug Administration's new drug application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following: * Is the drug safe and effective in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks? * Is the drug’s proposed labeling (package insert) appropriate, and what should it contain? * Are the methods used in manufacturing the drug (good manufacturing practice ()) and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity? Exceptions to this process include voter driven initiatives for "medical" marijuana〔http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421163.htm〕 in certain states. ==Before trials== To legally test the drug on human subjects in the U.S., the maker must first obtain an Investigational New Drug (IND) designation from FDA. This application is based on nonclinical data, typically from a combination of in vivo and in vitro laboratory safety studies, that shows the drug is safe enough to test in humans Often the "new" drugs that are submitted for approval include new molecular entities or old medications that have been chemically modified to elicit differential pharmacological effects or reduced side-effects. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「New drug application」の詳細全文を読む スポンサード リンク
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