Essay On Pharmacovigilance

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Pharmacovigilance is defined as study and surveillance of post marketed drugs. The importance of pharmacovigilance is to ensure the safety of drugs consumed by patients. So, why U.S. Food and Administration (FDA) still surveillance post marketed drug even though, these drugs go through such vigorous review, follow strict procedures and standards that are in compliance with GMP established by FDA during clinical trials and also goes through CDER. The Center of Drug Evaluation and Research (CDER) is a part of FDA that is responsible for the safety and effectiveness of all drugs ranging from prescription drugs to over-the-counter, which includes; shampoo, deodorant, sunscreens, vitamins etc. The way the research and investigation at CDER works is that, there are different departments for types of products. For example; generic drug, clinical review, biotechnology products or therapeutics products. Not only, CDER is responsible for safety and effectiveness of the drugs but they also provide information on how to use the drugs safely and effectively for both healthcare professional and co...

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