Navigating the landscape of paediatric clinical trials under US FDA guidelines
Abstract
Working under the guidelines of US Food and Drug Administration (FDA) legislation, this article investigates the complex arena of children’s clinical trials (CTs). It emphasises the crucial rules and ethics involved, places particular emphasis on the need for immediate research developed for children, and discusses the challenges posed by these trials.
This article highlights the necessity of collaboration between regulatory agencies, pharmaceutical companies, researchers and medical professionals in a bid to increase paediatric CTs and provides assurance on the safe and potent use of children’s drugs.
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