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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