Planning the joint development of companion diagnostics
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Donna Roscoe, PhD, from the Department of Molecular Genetics and Pathology
The Office of In Vitro Diagnostics and Radiological Health at CDRH discusses points to consider when planning companion diagnostics, including the use of investigational tests, the impact of study design on indication, common pitfalls, and how to obtain regulatory feedback.
For more information, visit: 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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FDA CDER's Small Business and Industry Assistance (SBIA) provides training and assistance in understanding the regulatory aspects of human drugs and clinical research.
The Office of In Vitro Diagnostics and Radiological Health at CDRH discusses points to consider when planning companion diagnostics, including the use of investigational tests, the impact of study design on indication, common pitfalls, and how to obtain regulatory feedback.
For more information, visit: 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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FDA CDER's Small Business and Industry Assistance (SBIA) provides training and assistance in understanding the regulatory aspects of human drugs and clinical research.
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