Watch our free webinar: Successfully Submitting a 505(B)(2) Application

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 a right of reference, relying instead on previously published material.

In this webinar, we discuss which candidates are best suited for 505(B)(2), and how to to successfully use the 505(b)(2) mechanism for approval.

You’ll learn:

  • 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