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.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.