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505(b)(2) – Part 2: The Assessment: Regulatory Strategy

Regulatory Strategy

This section provides analysis of pertinent regulatory information to produce a recommended regulatory pathway.  A thorough search of regulatory documents supports the regulatory recommendations (e.g., Dockets Management; HeinOnline[1]).

The 505(b)(2) regulatory pathway may be appropriate if part of the NDA application requirements can be supplied using information from published literature and/or the Agency’s findings of safety and effectiveness for a previously approved drug product (same or similar drug substance or product).  Products appropriate for the 505(b)(2) regulatory pathway may avoid the time and cost of conducting additional or repetitive preclinical or clinical studies if previous findings for safety and/or efficacy can fulfill FDA requirements.  Products not fitting the criteria for the 505(b)(2) submission will be considered for the 505(b)(1) or ANDA pathways.  A brief overview of potential market exclusivity and patent information is also provided.


[1] HeinOnline, William S. Hein & Co., Inc. Copyright 2007, http://www.heinonline.org/