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U.S. Department of Health and Human Services


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Development Resources

The role of the FDA in the early stages of drug research is small. The Federal Food, Drug, and Cosmetic Act does not give the agency responsibility to develop new drugs. So, FDA physicians, scientists, and other staff review test results submitted by drug developers. The FDA determines whether the drug is safe enough to test in humans and, if so--after all human testing is completed--decides whether the drug can be sold to the public and what its label should say about directions for use, side effects, warnings, and the like.