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Learning about the process that a drug has to go through till it can reach market is a complex web that the translator needs to know to address the translation task successfully. It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.
If the FDA gives the green light, the "investigative" drug will then enter three phases of clinical trials. The company then submits an application (usually about 100,000 pages) to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe. At this stage, the drug company will continue to report cases of adverse reactions and other clinical data to the FDA.
Understanding this cycle is vital for medical translators and, once digested, it can become an endless source of reference, reliable sources of information and terminology, and a valuable self-catering training tool.
This training course is divided into 2 parts, in order to cover broader content.