Free White Paper
505(b)(2) Pathway
Inside this White Paper
The 505(b)(2) regulatory pathway provides a framework for sponsors to reformulate existing immediate-release drugs into extended-release versions, utilizing existing data to streamline the approval process. Key insights are presented on strategic methods for identifying candidates, developing formulations, and designing clinical trials, with a strong emphasis on the necessity of comprehensive research and adherence to regulatory standards. By applying these strategies, sponsors can successfully manage the complexities of drug development and may decrease the time and costs involved in introducing new therapeutic options to the market.