Does safety monitoring continue after a drug is approved by the FDA?

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The safety monitoring continues for medicines long after FDA approval has been granted. Manufacturers are required to notify FDA immediately of any potential issues or concerns about a particular medicine. They also must submit summary reports to the FDA every three months on any "adverse events" associated with a medicine. These quarterly reports are required for three years following approval, followed by annual reports for as long as the drug is available to patients. Serious and unexpected adverse events must be reported to the agency within 15 days.

Sometimes, the FDA requires a manufacturer to conduct additional studies. Known as Phase IV or "post-marketing" studies, they evaluate long-term safety or generate more data about how the medicine affects a particular group of patients, such as children or the elderly. Phase IV studies can continue for years and involve thousands of patients.

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Drug Safety

Drug Safety

Prescription and OTC drugs marketed in the United States go through a review and testing process by the Food and Drug Administration (FDA). Dosage, side effects, manufacturing and safety are evaluated through this process. Familia...

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Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.