505(b)(2) Application

A 505(b)(2) application is a type of request submitted to the U.S. Food and Drug Administration (FDA) for the approval of a new drug. It allows drug developers to use some existing studies or public data instead of conducting all the typical clinical trials. This pathway is useful for drugs that are similar to already-approved products, or those with unique characteristics making the full trial process less necessary. It balances the need for safety and efficacy with a more streamlined approach, potentially speeding up access to new treatments for patients.