Download Our Latest Paper: Seven Noteworthy 505(b)(2) Submissions

As drug and device consultants, the scientists and regulatory experts at PDG® spend a considerable amount of time working on 505(b)(2) NDA submissions. This paper highlights notable features of a cross section of recent 505(b)(2) approvals and provides a variety of everyday issues to consider as you contemplate your next drug development project. Click here to view the full article.

From time-to-time, we add a new paper to the “Regulatory Updates” section of our website and invite you to visit anytime. Topics cover a wide range of subjects of interest to drug and medical device professionals.