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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 3
First page : ( 1409) Last page : ( 1414)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00258.9

Expedited programs for Drug Development and Approval in USA

Arjun S., Venkatesh M P*, Balamuralidhara V, Kumar T M Pramod

Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru-570015, Karnataka, India

*Corresponding Author E-mail: venkateshmpv@jssuni.edu.in

Online published on 22 April, 2020.

Abstract

Expedited programs is generally used in the development of drugs useful for the treatment of serious and life-threatening diseases. FDA has provided different programs such as accelerated approval, fast track, breakthrough therapy and priority review to speed up the review procedure of new drugs for the people in need. A wide range of approaches are utilized by these pathways to improve the effectiveness as well as to shorten the time required for review and also to increase the interactions between regulatory authorities and drug developers. In 2017, approximately there were 30000 recognized diseases where 6000 to 8000 are considered as rare diseases where in 70% of these are genetic in origin. It is important to understand the nature of the expedited programs and review the guidelines, since the pathways utilises range of approaches. Expedite program helps to identify the most promising therapies, promote research discoveries, and speed the FDA's review process and development of new drugs to improve the health of people.

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Keywords

Drug approval, rare diseases, fast track, breakthrough therapy priority review.

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