This article is a sequence of United States: Drug Approval Regulatory Process Part-I which describes the Investigational New Drug (IND) approval process, New Drug Approval (NDA), and Generic drug approval process. In this article, we will discuss the marketing approval process of Biologics, Biosimilars, Orphan drugs, and various approval pathways. Which is the regulatory authority for biologics […]

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The U.S. represents the largest continental pharma market worldwide and holds around 45% of the global market The US pharmaceutical market is projected to increase from $354bn in 2015 to $497bn by 2020, according to a report. Though markets like china and Indian have shown a great leap in the pharma market, the United States […]

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