Author(s): Syed Shakeeb Ahmed, Shailesh T, Hemanth Kumar S, Gangadharappa H.V, Gowrav M P

Email(s): shailesht@jssuni.edu.in

DOI: 10.5958/0974-360X.2021.00092.5   

Address: Syed Shakeeb Ahmed, Shailesh T*, Hemanth Kumar S, Gangadharappa H.V, Gowrav M P
Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, Mysuru, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru - 570015, Karnataka, India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 1,     Year - 2021


ABSTRACT:
Post approval changes are the non-avoidable changes due to the many reasons for improving products quality and safety. According to US-FDA the changes which are made after the approval of the product are supposed to be reported as major, moderate and minor changes based on the impact on the process and filings. The post approval changes to approved generic products according to US-FDA regulations are the changes which includes the contents and composition, production sites changes, manufacturing or production process changes, container and closure system changes, specification changes, labeling changes and other miscellaneous changes. Hence United States regulatory authority requires that all changes to be thoroughly reviewed by the regulatory team before any changes are implemented for the particular commercialized product. The current study endeavours on the role post approval changes to the approved generic product or ANDA application.


Cite this article:
Syed Shakeeb Ahmed, Shailesh T, Hemanth Kumar S, Gangadharappa H.V, Gowrav M P. An Overview on Post Approval Changes to an Approved ANDA in US-FDA. Research J. Pharm. and Tech. 2021; 14(1):506-512. doi: 10.5958/0974-360X.2021.00092.5

Cite(Electronic):
Syed Shakeeb Ahmed, Shailesh T, Hemanth Kumar S, Gangadharappa H.V, Gowrav M P. An Overview on Post Approval Changes to an Approved ANDA in US-FDA. Research J. Pharm. and Tech. 2021; 14(1):506-512. doi: 10.5958/0974-360X.2021.00092.5   Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-1-92


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2.    Lokesh M.S., N. Vishal Gupta, Bhushan Dinesh Belagoankar. Comparative Study of Process of Post Approval Change Application Submission and Approval for Marketing Authorization Variations in EU, US, India, Saudi Arabia and Singapore. International Journal of Drug Development and Research 2015 Jan;7(1):0975-9344. Available at: http://www.ijddr.in/drug-development/comparative-study-of-process-of-post-approval-c hange-applicationsubmission-and-approval-for-marketing-authorization-variations-in-eu us-india-saudi-arabia-and-singapore.pdf
3.    ANDA [Internet], Available from: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/default.html  
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6.    Code of federal regulation title 21 CFR 314.70 [online] Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.70
7.    Balasubramanian et al. Supac: A Regulatory Approach for High Quality Documentation in Chemistry, Manufacturing and Control (CMC). World Journal of Pharmacy and Pharmaceutical Sciences. Volume 7, Issue 5, 437-452
8.    Rahulgiri Goswami, Dr. Dilip Maheshwari. Comparative Study of Regulatory Requirements for Post-Approval Changes in US, Europe and South Africa. JPSBR: Volume 4, Issue 1: 2014 (177-183)
9.    Manufacturing Site Change Supplements: Content and Submission [online] Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/manufacturing-site-change-supplements-content-and-submission
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