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INTERNATIONAL JOURNAL OF SCIENTIFIC DEVELOPMENT AND RESEARCH International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016 open access , Peer-reviewed, and Refereed Journals, Impact factor 8.15 |
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| Paper Title: | A Review on an Orphan Drug Regulatory Issues and Development |
| Authors Name: | PATIL AKASH RAVINDRA , VISHAL GAIKWAD |
| Unique Id: | IJSDR2210041 |
| Published In: | Volume 7 Issue 10, October-2022 |
| Abstract: | The orphan drugs Act offers the pharmaceutical sector a set of incentives and requirements to produce medications for the treatment of rare disorders. The incentives, implemented through laws first passed in the US in 1983 and afterwards in Japan, Europe, and other countries, have led to significant advancements in the treatment for people with a variety of rare diseases. Concerns about trial designs that must be addressed in order for medicines to treat rare diseases to be approved are particular to the international research community. Safety and efficacy for orphan products cannot be compromised, a number of factors influence the research strategy and present challenges for researchers. There have been some lengthy discussions and reflections on the necessity of specific orphan drug laws or policies. Additionally, some characteristics of each region's history in relation to the development of orphan drug legislation are described... The orphan drug laws or policies of various nations or areas are discuss |
| Keywords: | Orphan Drugs, Rare Diseases, Incentives |
| Cite Article: | "A Review on an Orphan Drug Regulatory Issues and Development", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.7, Issue 10, page no.239 - 247, October-2022, Available :http://www.ijsdr.org/papers/IJSDR2210041.pdf |
| Downloads: | 000338719 |
| Publication Details: | Published Paper ID: IJSDR2210041 Registration ID:202016 Published In: Volume 7 Issue 10, October-2022 DOI (Digital Object Identifier): Page No: 239 - 247 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
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