CPC Provides Comments on FDA’s “Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications: Draft Guidance for Industry and FDA Staff”

While CPC supports certain recommendations detailed in the Draft Guidance, we also recommend several revisions.  For example, we ask that FDA revise the document to provide clear guidance and delineation as to which HF tools are applicable to which types of submissions/situations. We also ask that FDA only request that sponsors provide representative samples of their own product for certain submission types and remove the request for samples of competitors’ reference products.