For example, when a new drug is created it must undergo lengthy testing by the U.S. Food and Drug Administration (FDA) before it is approved. If the work takes place at a university, the drug development program must pass through a scrutinizing R & D committee before it can even get off the ground. The lengthy process of FDA approval, in turn, is a nightmare of bureaucratic red tape. Researchers must go through pre-clinical tests using both in vitro (test tube) experiments and in vivo (living animal) studies. At this point, researchers file for an "initial new drug" (IND). All work is highly regulated and must be supported with massive amounts of data. The drug then enters Phase I testing, involving a small number of humans to look for side effects. If approved for Phase II, researchers must recruit more subjects. Phase III involves even larger numbers of test subjects. An investigation may be ended at any point; some drugs have reached phase III and not been approved. Other Western countries have similar procedures, although the time taken may be shorter.
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