Topic > Essay on Pharmacovigilance - 573

Pharmacovigilance is defined as the study and surveillance of post-marketed drugs. The importance of pharmacovigilance is to ensure the safety of drugs consumed by patients. So, why does the US Food and Administration (FDA) continue to monitor post-market drugs, even though these drugs undergo such rigorous review, they follow rigorous procedures and standards compliant with GMPs established by the FDA during clinical trials and also pass through the CDER. The Center for Drug Evaluation and Research (CDER) is a part of the FDA responsible for the safety and effectiveness of all drugs, from prescription to over-the-counter drugs, which include; shampoo, deodorant, sunscreen, vitamins etc. The way research and investigation works at CDER is that there are different departments for types of products. For example; generic drugs, clinical reviews, biotechnology products or therapeutic products. Not only is the CDER responsible for the safety and effectiveness of medications, but it also provides information on how to use medications safely and effectively for both healthcare professionals and colleagues....