The 505(b)(2) Drug Development Pathway: When and How to Take Advantage of a Unique American Regulatory Pathway

Posted 01 April 2010 | By

The 505(b)(2) regulation offers a less expensive and faster new drug development pathway that may be particularly attractive to a manufacturer with experience in developing generic products. It involves making significant changes to an existing product approved by the US Food and Drug Administration (FDA), called the reference product, to create a new drug with its own indication, formulation, target population and/or other differences that need to be supported with clinical studies. A major advantage of this pathway is that it allows a sponsor to rely, at least in part, on FDA's findings of safety and/or effectiveness for the previously approved drug, thereby reducing the number of clinical trials required for approval. Another incentive is three to five years of market exclusivity for 505(b)(2) products, depending upon the extent of changes to the reference product and the type of clinical data included in the approved New Drug Application (NDA).


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