Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products" and encourages the submission of premarket approval application (PMA) supplements containing the needed information to modify the intended use of specific companion diagnostics as described in this notice (i.e., companion diagnostics that identify patients with nonsmall cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and are suitable for treatment with a tyrosine kinase inhibitor approved by FDA for that indication). This guidance describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as companion diagnostics in this document) to support the indicated uses of multiple drug or biologic oncology products (referred to as therapeutic products or oncology therapeutic products in this document), when appropriate. The guidance includes factors for considering when broader labeling (i.e., labeling that is