FDA Issues Draft Guidance Regarding ANDA Submissions for a Drug-Device Combination

January 17, 2017 – FDA issued a draft guidance entitled, “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry.”  The “guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a proposed combination product that includes both a drug constituent part and a delivery device constituent part.”  The docket identification number is FDA-2016-D-4412-0002.

By: Joyce L. Nadipuram