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In order to protect consumers and ensure that marketed drugs are safe and effective, the FDA has established a system of pre-clinical and clinical trials that weigh risks, test optimal dosage, establish proper duration of treatment, and determine what group of patients would benefit the most from treatment. In most cases it takes at least 12 years for a drug to weave its way from pre-clinical research to FDA approval. A fast track system, however, is in place to speed up trials and FDA approval for drugs that are deemed to be critical in saving many lives (HIV drugs, for example).
The expense of bringing a new drug to market is very high (see the chart below). Therefore, it's important that ineffective or dangerous drugs be weeded out early. By the time a drug gets the go ahead to enter Phase III clinical trials, there's a reasonably good assumption that it has proven itself to be safe and effective. About 45% of drugs entering Phase II trials go on to Phase III, and 85% of those entering Phase III actually complete the last stage. In the end, only about 40% of drugs beginning Phase II, complete Phase III, but of those that finish, there's more than a 70% chance of FDA approval. The following is an overview of the FDA approval process followed by some links of interest to sites that offer more specific information.
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