Which FDA center oversees new drug review for safety and effectiveness?
Answer
Center for Drug Evaluation and Research (CDER)
The Center for Drug Evaluation and Research (CDER) is explicitly tasked with overseeing the review process for human and animal drugs. This oversight involves a critical examination of clinical trial results submitted by manufacturers to determine if the known or potential benefits of a new medication outweigh its known or potential risks for the intended patient population. This scientific scrutiny is fundamental to ensuring that any pharmaceutical product, from prescription medications to OTC pain relievers, is both safe and effective before it becomes available to the public.
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