We collected information from different sources: the FDA “List of Cleared or Approved Companion Diagnostic Devices”, the FDA’s Medical Device Database, and the Drugs@FDA database. We covered all CDx approved between 1997 and July 2023 and created a searchable database (using Excel). 
This database can be utilized to assess the regulatory strategy used for the development of the companion diagnostic device, and to search for regulatory precedents, identifying in which scenarios drugs got approved under the condition to provide a clinical validation study to establish the performance of a companion diagnostic device in a post market commitment study.
Overall, this database is a great tool for regulatory strategists when defining CDx development and registration strategy.

Exploring regulatory trends and precedents with an internal database of FDA-approved Companion Diagnostics (CDx) in oncology

DIA Europe 2024 will focus on sustainability, innovation and collaboration – three key pillars for shaping the future of healthcare. From the environmental impact of pharmaceuticals and of the drug development lifecycle to sustainable partnerships and sustainable healthcare systems, DIA Europe 2024 will be the prime opportunity to discuss how collaboration and innovation can support sustainability in healthcare and each stakeholder’s role in making it happen.

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DIA Europe 2024

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