Showing posts from May, 2019

FDA releases guidance for choosing ANDA or 505(b)(2) route for drug approval

Last week the FDA released a guidance entitled “Determining Whether to Submit an ANDA or a 505(b)(2) Application” to help companies choose between those two routes for the approval of a proposed drug that contains an already-approved active ingredient. You can download the guidance directly from  here . After reading through the guidance, I came to the conclusion that the major difference between ANDAs and 505(b)(2) applications can be found where it states: The types of studies that may be submitted in a 505(b)(2) NDA may include clinical investigations to establish the safety and/or effectiveness of a product. Generally, ANDA applicants also have significant flexibility in the types of studies, data, and information they may submit in an ANDA to support the requirements for ANDA approval,  so long as clinical investigations are not submitted to establish the safety or effectiveness of a product . Page 7, Section B, Subsection 1. (emphasis added) So there you have it in a