The drug approval process in Japan is less complex and easy when compared to some other countries beyond the language barriers. In addition to regulatory considerations, the PMDA offers sponsors consultation to assist them in understanding the prerequisites and the detailed procedure for drug approval. As a result of this positive change, many manufacturers choose […]
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Clinical research professionals and staff members say that one of their biggest challenges in conducting a clinical trial is patient recruitment which is obtaining a sufficient number of participants for a clinical trial. If the clinical research team fails to enroll enough study subjects into a clinical trial, this may, by default, extend the study […]
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Many companies spend a significant amount of cost and manpower on software and data management tools/systems to handle clinical trial activities to build, monitor, and manage clinical trial data. Researchers and CRO utilize many software, web-based applications, and cloud source management tools in various stages of clinical development, and here are some of them Now, […]
Read More →Many people with rare diseases struggle to find the right diagnosis and right treatment for years. The lack of awareness about these conditions makes 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 in the pharma industry towards rare disease research 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 like Novartis, GSK, Roche, and Pfizer are extremely active in […]
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In 2019, the global generic drugs market reached a value of US$ 367 Billion. with a CAGR of 5.7% during the period 2014-2019. The US generic drug market is foreseen to reach US$ 208.6 Billion by 2025, with a projected CAGR of 10.46% during 2020-2025, according to a report by IMARC Group, The global biosimilars […]
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Regulatory agencies in various countries are providing benefits & regulatory incentives for orphan drugs such as faster approvals, fee concessions, and financial benefits, and many more. These incentives are to support and encourage pharma companies to work on developing orphan drugs or medical devices for rare diseases. The countries that provide regulatory incentives include the […]
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Orphan drug designation for rare disease qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing, so let’s know more about Orphan drug designation Worldwide orphan drug sales are forecast to grow at a CAGR of 12.3% from 2019 to 2024, which is approximately double […]
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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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Most of the processes to approve drugs in the EU are similar to those of the FDA, such as getting pre-authorization for use of the drug in clinical trials. After clinical trials, FDA drug approvals follow a centralized path, whereas European approval can occur through 4 different paths, depending on the nature of the drug, timeline, […]
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