Food and Drug Administration (FDA) is the federal health organization ensures the safety and effectiveness of medications.
In order to improve the health of people in the United States, the Center for Drug Evaluation and Research (CDER) ensures that safe and effective medications are available.
By ensuring the security, efficacy, and safety of human and veterinary medications, biological products, medical devices, our country's food supply, cosmetics, and radiation-emitting equipment, protecting the public's health is the responsibility of the FDA.
Premarket approval, also known as a preapproval review, is the procedure by which the FDA first evaluates the efficacy and safety of new pharmaceuticals that manufacturers want to market in the United States. Once a medication has achieved that mark and received FDA approval, FDA takes action through its post-approval regulatory procedures.
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