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What is a PADER

PADER stands for Periodic Adverse Drug Experience Report. It is a report that pharmaceutical companies are required to submit to the U.S. Food and Drug Administration (FDA) on a regular basis for any approved drug. The report provides information about adverse events (side effects) associated with the drug that have been reported since its approval, including serious adverse events and events that are rare or occur over a long period of time.

The PADER is a comprehensive report that includes data from clinical trials, post-marketing studies, and spontaneous reports of adverse events from healthcare professionals and patients. The report is required to be submitted at regular intervals, usually annually, for the first three years after a drug is approved and then every three years thereafter.

The purpose of the PADER is to provide the FDA with updated information about the safety of a drug over time. It helps the FDA to identify new safety concerns or trends that may require further investigation or action, such as changes to the drug’s labeling or prescribing information.

Overall, the PADER is an important tool for monitoring the safety of drugs on the market and ensuring that they continue to be safe and effective for patients.

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