Description: In order to have a successful submission to FDA for companion diagnostics, there are several elements that need to be encompassed. The development, collection, and compilation of data is crucial for a successful submission. Diagnostic companies need to navigate the PMA process by having the most up to date knowledge of FDA regulation and guidance documents. There are several elements to a successful PMA approval, including ensuring a comprehensive PMA strategy taking in to account the iterative process with FDA during submission review.
Learning Objectives:
Upon completion of attendance, each participant will understand about early and continuous engagement with the FDA during the review process, depending on the submission type.
Upon completion of attendance, each participant will understand PMA strategy and submission requirements.
Upon completion of attendance, each participant will understand the essential activities after successful PMA approval.
