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"dNDAs"

This article was originally published in The Tan Sheet

Executive Summary

Approved Rid Mousse "NDA Deviation" may open the door to other such applications being filed with the agency, FDA indicates (1"The Tan Sheet" March 13, p. 4). "dNDAs" allow an applicant to file only that data supporting the proposed change to a monograph drug, such as a new formulation, rather than all of the data required under an NDA. According to FDA regulations, "A new drug application requesting approval of an OTC drug deviating in any respect from a monograph that has become final shall be in the form required by Sec. 314.50 of this chapter, but shall include a statement that the product meets all the conditions of the applicable monograph except for the deviation for which approval is requested and may omit all information except that pertinent to the deviation"

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