What is the role of the FDA in the approval of drugs?

The U.S. Food and Drug Administration (FDA) is the federal agency responsible for regulating pharmaceuticals in the United States, including North Carolina. The FDA is responsible for ensuring that prescription and over-the-counter (OTC) drugs are safe and effective for use, as well as supporting innovation and development of new treatments. The FDA plays an essential role in the approval process for new drugs. To be approved by the FDA, a drug must first go through animal and human clinical trials to demonstrate its safety and effectiveness. Once trials are complete, the sponsor of the drug (usually the drug manufacturer) must submit detailed information in a New Drug Application to the FDA. The FDA reviews the application and conducts inspections to ensure that the drug is safe and effective. The FDA can also monitor drugs through post-marketing surveillance. This means that the agency looks for trends in adverse events reported by patients and physicians, and can take action, including recalling a drug, if it is not meeting expected safety and efficacy standards. Ultimately, the role of the FDA in drug approval is to ensure that the drugs available to the public have been thoroughly tested and are safe and effective for their intended use. This helps ensure that drug companies are meeting the safety and efficacy standards required by the FDA to protect the public from ineffective or unsafe products.

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What is the role of the FDA in the approval of drugs?

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