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From Lab Bench To Bedside: How the FDA is Using New Technologies to Ensure the Safety and Effectiveness of America's Medicines

Monday November 2006


Dr. Scott Gottlieb Deputy Commissioner for Medical and Scientific Affairs, U.S. Food and Drug Administration

Since its inception in 1906, the FDA’s mandate has grown to encompass the safety of a wide array of consumer goods, ranging from cosmetics to vaccines and even cellular phones. Today, the agency regulates products that account for 25 percent of U.S. consumer spending, or about $1 trillion each year.

But the FDA’s best known responsibility is ensuring that Americans have timely access to safe and effective medicines for treating illnesses ranging from cancer to Alzheimer’s disease. As a result, the agency must make complex decisions involving the prospective benefits and risks of new medicines before they are approved for public sale—decisions that are, by their very nature, open to criticism and debate.