Understanding the FDA Approval Process

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.