FDA

Food and Drug Administration (FDA) Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) is the US federal agency responsible for approving drugs and medical devices. The FDA came into being when its predecessor, the Bureau of Chemistry, which was created in 1906 and tasked with user safety, changed its name in 1930. The FDA falls under the US Department of Health and Human Services.

Today, the FDA is responsible for the protection of public health. The ensure that food as well as human and animal pharmaceuticals are safe. They also oversee medical devices, radiation-emitting devices, biological products, and cosmetics.

As part of the aforementioned responsibilities, the FDA is also responsible for the approval of pharmaceuticals. After performing clinical studies, pharmaceutical companies must present their findings to the Center for Drug Evaluation and Research (CDER) for inspection. Medicine is only approved once the CDER experts decide that the health benefits outweigh the known risks.

More information to the different applications that can be submitted to the FDA can be found here.

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