The Impact of Leading Regulatory Strategies on the First Cycle Approval of a New Drug Application in the USA
Abstract
Approximately 100 million people die every year in the world. Of these an estimated 65 million people die due to various disease of which 25 million of those die due to incurable disease (WHO, 2013). Needless to say, the speedy approval and availability of potent new drugs to fight those diseases presents exciting possibilities worldwide for healthcare systems, doctors, and patients. New drug development has saved millions of lives globally and improved the quality of life for countless patients over the years (Papanicolaou, Skyes, & Mossialos, 2004)
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