---
title: Successfully Submitting An Application via the 505(b)(2)
description: "white paper: Successfully Submitting an Application Via the 505(B)(2) Mechanism - How to use previously published material to save time and money during approval."
image: https://www.thefdagroup.com/hubfs/Images/Covers/fda-WP-505(B)(2)-Cover.jpg
---

| ![](https://www.thefdagroup.com/hubfs/Images/Covers/fda-WP-505(B)(2)-Cover.jpg) | Get our free guide # Successfully Submitting an Application Via the 505(B)(2)  **How to use previously published material to save time and money during approval** Since 1984, the 505(B)(2) Mechanism has given companies a streamlined path to drug product approval with fewer required studies and without aright of reference, relying instead on previously published material. Discover which candidates are best suited for 505(B)(2), and how to navigate the process effectively. **What you'll find inside:** - Four key benefits of 505(B)(2) - How to prevent common problems during the process - The key differences between an average and outstanding 505(B)(2) application [Get my free guide »](https://www.thefdagroup.com/successfully-submitting-an-application-via-the-505-b-2#) |
| --- | --- |
| [![FDA logo](https://www.thefdagroup.com/hubfs/template_2019/img/logo.svg)](https://www.thefdagroup.com/) The FDA Group, LLC will not be liable for any errors or omissions in this information nor for the availability of this information. The owner will not be liable for any losses, injuries, or damages from the display or use of this information. [Privacy Policy](https://www.iubenda.com/privacy-policy/7819312) |  |

### Get the Guide

![](https://dc.ads.linkedin.com/collect/?pid=19851&fmt=gif)