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Fda Approvals for Medical Trials

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Submitted By eh7797
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FDA Approval process for Clinical Trials

If you, or someone you loved, were diagnosed with a terminal disease, would you chance using a non-FDA approved medication to increase your life expectancy? Many pharmaceutical companies have the medication that could save countless lives, but the FDA clinical trials for these medicines are problematic for enrollment, and thousands of patients are often turned down.
New drugs are vitally important to improving the lives and health of Americans. Between 1986 and 2000, new drugs were responsible for 40 percent of the total increase in life expectancy. Yet, the FDA’s clinical trial process remains lengthy and expensive. It takes, on average, more than a decade to bring a new drug from the laboratory to the market. Polls show a clear majority of specialists believe the FDA clinical trial process is too slow and most report having been personally hindered in treating a patient due to the FDA approval process. The clinical trial process initiates when a drug developer submits an Investigational New Drug Application (IND) to the FDA. The IND application includes all available data on the proposed investigational drug, including the results of any animal testing. In reviewing IND applications, the FDA seeks to ensure that the proposed trial does not expose patients to “unreasonable risk of harm.” Clinical trials then move ahead in three mandatory human testing phases. Phase I consists of giving the investigational drug to a smaller group of 20 to 80 volunteers to test for toxicity and instantly apparent side effects. The major importance of Phase I testing is safety. Over 60 percent of investigational drugs in Phase I testing are considered safe enough to move on to Phase II. While safety continues to be evaluated, the main focus of Phase II is the drug’s effectiveness in treating the targeted disease or...

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