This article is a sequence of Drugs: Regulatory Approval in the United States 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. What is the regulatory 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 has shown a great leap in the pharma market, the United States […]

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Japan’s pharmaceutical market is one of the largest in the world, with figures from the Ministry of Health, Labour and Welfare (MHLW) indicating a market value of about $95 billion, including non-prescription medications. Analysis of various show that the country’s market for drugs will continue to grow, driven by a range of factors, for example, […]

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Any clinical research professionals and staff members say that one of their biggest challenges when conducting a clinical trial is, obtaining a sufficient number of participants.  If the clinical research team fails to enroll enough study subjects into a clinical trial, this may, by default, extend the study timeline, increasing resource usage and costs. A […]

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Most of the companies are spending a significant amount of cost and manpower to manage clinical trial activities as database building, monitoring and management of data using a variety of EDC systems as Inform, Rave, Oracle Clinical Remote Data Capture, Veracity, etc. Many software, web-based applications, and cloud source management tools are being used in […]

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Many people with rare diseases struggle to find the right diagnosis and right treatment for years. The lack of awareness about these conditions make it much harder for them to get the right treatment. Rare Disease Day is all about raising awareness for rare diseases. And, this year, you can join these efforts too. The […]

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In recent years there is a huge leap of pharma industry towards rare diseases and orphan drug developments due to the great support from regulatory authorities such as faster approval timelines, supportive regulatory frameworks, financial incentives, and many more. Currently, large pharmaceutical companies are extremely active in the orphan drugs market. Novartis, GSK, Roche, and […]

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In a way to support and encourage pharma companies to work upon developing drugs or medical devices in rare disease, several country regulatory agencies are coming up with various benefits such as faster approvals, fee concessions and financial benefits etc. These countries include the US, Europe, Japan, Australia, South Korea and most recently, India. Incentives […]

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The US Food and Drug Administration (FDA) in 2019, has approved an increasing number of orphan drugs and biologics, as well as drugs targeted at specific cancers. The Center for Drug Evaluation and Research (CDER) has reported that this value was more than twice compared to the past eight years. Worldwide orphan drug sales are […]

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