Planning for Co-development of Companion Diagnostics



Donna Roscoe, PhD, from the Division of Molecular Genetics and Pathology
Office of In Vitro Diagnostics and Radiological Health at CDRH, discusses points to consider when planning for companion diagnostics including use of investigational tests, how trial design can impact indication, common pitfalls, and how to obtain regulatory feedback.
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/oncology-therapy-development-workshop-pivotal-steps-and-avoiding-pitfalls-start-ups-03302021
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