Essential First Steps to FDA 505(b) (2) Drug Approval

19 February 2008, United States

Introduction

Today, start-up and small pharmaceutical companies use the FDA's 505(b)(2) approval pathway to modify and reposition existing drugs for more predictable, lower risk, and less costly marketing clearance. Similar to a 505(b)(1) submission for new molecular entities, 505(b)(2) requires the submission of a full NDA. This 90-minute webinar will teach you why and how a properly submitted 505(b)(2) can be the difference between success and failure of a new drug approval.