High Quality 505(b)(2) Trial Conduct
The key to a viable 505(b)(2) New Drug Application (NDA) development strategy is identifying existing submission gaps early, and then planning for studies that will effectively bridge those gaps. The most common 505(b)(2) application flaw is the lack of appropriate data to support the proposed modification(s) of the Reference Listed Drug (RLD). As this pathway falls under the NDA application process, it is essential to meet with the regulatory body prior to initiating studies. The objective of the Pre-IND meeting review is to discuss both the scientific rationale and strategic planning behind the 505(b)(2) application.