Roadmap for revitalization?

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    • Abstract:
      The article focuses on the U.S. Food and Drug Administration (FDA) amendments act (FDAAA), related to post marketing surveillance and pre-approval process of the drugs. The new legislation enables FDA to make $392.8 million as user fee and would provide radical changes in surveillance of drug post marketing, enabling registration and reporting system of the drugs. Under this new legislation, the FDA has more powers to monitor and levy fines if manufacturers fail to meet post marketing demands. The factors as discusses stating why the act would leave marked impression are that the companies would comply with the act in order to save their image. The new act would ensure publicly accessible clinical trial results database and streamlined approval of the drugs.