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Posted by Shubham Gurav on April 16, 2024 at 1:31am 0 Comments 0 Likes
Clinical reviewers evaluate the reports in FAERS in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to monitor products’ safety after the FDA approves them.
If a potential safety concern is discovered in FDA Adverse Event Reporting System (FAERS), further evaluation is performed. Based on the evaluation, FDA may take regulatory action(s) to improve product safety and protect public health.
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