Clinical Trials and the FDA....These steps will take you there!!

From: Helen Dynda (olddad66@runestone.net)
Thu Jun 7 11:40:46 2001


1.) Enter: http://www.womenssurgerygroup.com/

2.) Click: Adhesions

3.) Click: Clinical Research

4.) First read: Clinical Trials and the FDA ( which is this article )

5.) Scroll back to the top...and Click: "Click here" to read: " Ongoing Clinical Trials."

Clinical Trials and the FDA...This is a primer that every woman considering participation in an FDA-approved clinical trial should read and understand.

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.

In 1928, the government formed a separate law enforcement agency, originally called the Food, Drug, and Insecticide Administration. In 1930, the name was changed to the Food and Drug Administration.

The foundation of the modern clinical trial process was enacted in 1938 with the Federal Food, Drug, and Cosmetic Act. This was also the first attempt to regulate cosmetics and medical devices. This act required that drugs be proven safe prior to marketing. The manufacturers of drugs now had to provide scientific proof of safety by submitting an Investigational New Drug (IND) filing prior to human trials, and a New Drug Application (NDA) before marketing new drug products.

In 1962, the FDA was thrust into public view as a result of the discovery that the use of Thalidomide, a sleeping pill, resulted in thousands of birth defects in western Europe. Because of the FDA's role in keeping the drug off the market in the U.S., the agency received a lot of positive press. Twenty years later, the much publicized deaths of seven people from Tylenol laced with cyanide prompted the passage of tamper-resistant packaging regulations by the FDA in 1982.

In 1983, the Orphan Drug Act provided incentives for drug companies to develop drugs for rare diseases.

Finally, in 1992, the Prescription Drug User Fee Act was passed, which required drug and biologic manufacturers to pay application and other fees to the agency. This revenue is used to hire more FDA reviewers, and has resulted in increased efficiency in the drug approval process.

The Clinical Trial Process

Phase 1

Phase 2

Phase 3

Phase 4


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