FDA has issued a new draft guidance document entitled “Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA.” The document provides guidance to industry and FDA staff on the underlying principles to determine the type of marketing submission that may be required for postapproval changes to a combination product that is approved under one marketing application (i.e., a biologics licensing application, a new drug application, or a premarket approval application). FDA regulations describe requirements related to postmarket submissions for changes to stand-alone products, but do not expressly address submissions for changes to combination products. The guidance intends to clarify and provide consistency with regard to the latter. Specifically, the document provides tables that may be helpful in determining what type of submission to use for a postmarket change to a constituent part of a combination product where the regulatory identity of the modified constituent part differs from the application type under which the combination product is approved. Comments on the draft guidance should be submitted, in writing or electronically, at www.regulations.gov by April 22, 2013.
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New FDA draft guidance addresses combination product postapproval modification submissions
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