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Clinical Trials and the FDA


The biotechnology sector has emerged as one of the hottest of the past year. More and more investors are pouring their money into this sector, hoping that companies will translate flashy new technologies into revenue-producing drugs. While biotechnology has come of age, and the number of profitable companies with products on the market has continued to swell, the vast majority of companies are still pinning their hopes on the positive outcomes and subsequent FDA approval of the drugs being tested in clinical trials. This article is for those investors who are interested in learning a little more about the FDA and the clinical trial process.

The FDA, short for Food and Drug Administration, is the government agency responsible for ensuring the health and safety of consumers in the areas of drugs, biologics, food, cosmetic products, and medical devices. It is the agency’s mission to ensure that these products are safe, effective, and are produced under sanitary conditions. In addition, all product packaging and labeling should be truthful, informative, and not deceptive in any way.

The FDA: A Short History
The FDA’s roots date back to 1862, when Abraham Lincoln appointed chemist Charles M. Wetherill to serve in the newly created Department of Agriculture. Wetherill’s appointment marked the beginning of the Bureau of Chemistry, later the Food and Drug Administration. In 1902, the Biologics Control Act was introduced, which authorized the Public Health Service to regulate and license biological drug laboratories in the production of antitoxins used in vaccines. The catalyst for this act was the death of 10 children after they received a vaccine shot. It was later discovered that the horse used in the production of the antitoxin was infected with tetanus.

In 1911, in response to the widespread sales of “snake venom” and other wonder cures, the Sherly Amendment was passed. This amendment made it a crime to make false claims in drug labeling.

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