Product Development Using the NDA 505(B)(2) Pathway

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A 505(b)(2) application is a new drug application that contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This approach can lead to approval in a fraction of the time and cost required by traditional paths. For 505(b)(2) in particular, early assessment and preparation are key to identifying needs and avoiding redundancies to set the path to a profitable product. Pre-investigational new drug (PIND) meetings serve as a prudent step in this process and can guide development strategies that reduce time to market and can all but eliminate the possibility of clinical holds.