Webinar: Principles for Co-development of In-Vitro Companion Diagnostic Device w Therapeutic Product
Channel: Invent Healthcare
Date: 2020-09-14

This draft guidance is intended to assist with the codevelopment of a therapeutic product and an accompanying IVD companion diagnostic. This guidance is also intended to assist FDA staff with reviewing companion diagnostics or their associated therapeutic products.

The guidance provides general principles for addressing issues that may arise when codeveloping a therapeutic product and a corresponding IVD companion diagnostic. It also provides considerations for planning and executing clinical trials and successfully fulfilling FDA regulatory requirements.


Date: August 17, 2016

Slides: https://www.fda.gov/media/99790/download



Guidance Document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/principles-codevelopment-vitro-companion-diagnostic-device-therapeutic-product