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
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:
000338720
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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