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The idea is to avoid cumbersome double-testing and approval procedures by both sides.
ECONOMIST: Europe and America
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For one thing, it signals that these companies are finding ways of using these new technologies to make their medicines more effective --making for better odds in getting Food and Drug Administration approval and reducing money wasted testing drugs that won't work in human beings.
FORBES: Genomics Revolution Actually Happens
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Merck is setting a good example by evaluating the drug in steps, carefully assessing its effect on patients, and not proceeding toward approval before testing the effect of the drug on patient outcomes in a large study.
FORBES: Merck Does The Right Thing
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Based on a thorough review of data submitted by Lilly that was obtained from pre-clinical testing in animals and clinical trials in thousands of diabetics, FDA granted marketing approval for human insulin in October 1982.
FORBES: When Genetic Engineering Came Of Age
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Carmat will begin testing about 20 of these bio-prosthetic hearts when it gets approval, and the process is expected to take about two years.
FORBES: Magazine Article