Review of 505(b)(2) Drug Products Approved by USFDA from 2010 to 2020: A Focus on Intellectual Property and Regulatory Considerations

A review article in the Journal of Pharmaceutical Sciences analyzes the trends in drug repurposing through the 505(b)(2) pathway, as approved by the USFDA from 2010 to 2020. The study aims to shed light on the challenges related to intellectual property (IP) protection and regulatory approvals faced during the development of reformulated and combination drug […] Source