Although
many Americans don’t realize it, the Food and Drug Administration (FDA) plays a
major role in determining what products citizens can purchase. The agency
regulates more than just prescription drugs and generic discount medicine. In
fact, over-the-counter medications, sunscreen, toothpaste, shampoo, and many
other health and beauty items also have to be approved by the FDA.
The Significance of FDA Approval
FDA approval means that the agency’s doctors and scientists have reviewed a
drug's New Drug Application (NDA) and determined that it is suitable for public
consumption. The Center for Drug Evaluation and Research (CDER) is the largest
of the FDA's six centers. The scientists at the CDER are responsible for
confirming that all prescription and nonprescription drugs are safe and
effective. Before any drug is marketed in the United States, it must have FDA
approval.
Testing
Manufacturers are responsible for submitting thorough research proving that
their new drug is safe and effective. They test the product in a lab on animals
and, eventually, on humans. The manufacturer submits all test results,
manufacturing information, and the proposed drug label, which must show uses,
side effects, and other information. In 2014, all of this research and
development meant an average $2.87 billion investment from drug developers.
Consumer Ready
If the FDA officials determine that the product’s benefits and effectiveness do
indeed outweigh the risks and side effects, the product is approved to be
marketed to the American public. Then the consumers can buy it at full price or
as a discount medicine.
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