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.
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