Finding External Critical Design Attributes

13th July 2018

In January, 2017, FDA introduced a draft guidance “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry” (ucm536959), to help potential applicants who plan to develop and submit an abbreviated new drug application (ANDA). In a nutshell, the guidance provides recommendations and […]