Review of the Investigational New Drug Application in the US FDA

Abstract

To ensure the safety of patients enrolled in clinical trials with investigational drugs, applications for new drugs under investigation are submitted to the FDA & Centre for Drug Evaluation and Research or Centre for Biologics Evaluation and Research while testing novel medications on human subjects raises ethical concerns; it is morally required to develop drugs to treat the wide range of human diseases and disorders. How do we strike the right balance between defending the person and the larger good? International government regulatory agencies are responsible for ensuring that medical professionals performing procedures on human beings are appropriately justified and closely monitored. This article focuses on the US FDAs legal approach to treating people with novel investigational products. Description of the drug substance includes physical, chemical, or organic properties. A standard method for manufacturing pharmaceutical products. Tolerance limits and analytical techniques to ensure drug identity, strength, quality, and purity. Sufficient records to illustrate the balance of the drug throughout toxicology research and deliberate medical trials.