Globally many consider herbs and botanicals to be natural and therefore healthier and gentler than conventional drugs. Currently, 30% of prescription drugs are herbal and botanical drugs. Herbals and botanicals are used for the treatment and improvement of health and well-being. Many countries use herbal and botanical drugs traditionally for many years to generations. The […]

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For the approximately 7,000 known rare diseases, less than 10% of diseases have an FDA-approved treatment available. Due to a small number of patients, limited understanding of the variability and progression of the diseases, developing a drug or treatment for rare diseases is often challenging. As the disease is rare, finding sites to conduct clinical […]

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The United States remains the largest medical device market in the world with $156 billion which is 40 percent of the global medical device market in 2017 and By 2023, it is expected to grow to $208 billion The medical technology industry (commonly referred to as medical devices) consists of articles, instruments, apparatuses, or machines […]

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This article is a sequence of the Regulatory & Drug Approval Process 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 market approval process of biologics, biosimilars, orphan drugs, and various drug approval pathways.  Which is the regulatory authority […]

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Many regulatory agencies across the world are offering incentives for the development of orphan drugs for rare diseases. These incentives include financial benefits, faster approvals, less stringent clinical data requirements, and many more. The countries that are offering the regulatory incentives for orphan drugs include the US, Europe, Japan, Australia, South Korea, Brazil, and most […]

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Foot ulcers refer to a patch of broken-down skin usually on the lower leg or feet. In diabetics, when blood sugar levels are high or fluctuate regularly, skin that would normally heal may not properly repair itself because of nerve damage. therefore start a foot ulcer. It occurs in 15% of people with diabetes and precedes […]

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Pancreatitis, inflammation of the pancreas, is the leading cause of GI-related hospitalizations in the USA and many other countries, with a medical condition requiring emergent care. The yearly incidence of Acute Pancreatitis in the United States and western countries is approximately 70-80 new cases per 100,000 population and has increased over the last decade. In […]

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Epidermolysis bullosa (EB) is a rare group of genetic disorders that cause the skin to be very fragile and to blister easily. It is a rare disease, and the condition was brought to public attention in 2004, in the UK through the Channel 4 documentary. It appears in many kinds of forms, and these forms are […]

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The United States is the region that conducts most clinical trials in the world and is the flag bearer for most clinical research studies requires considering many factors and areas. In the first part of this series of articles for clinical trials in the United States, we have seen the regulatory situation, clinical sites, and […]

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