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Companion diagnostics: Best practices for effective collaboration
RF Quarterly
Joshua D. Levin, PhD, RAC-Devices
•
Andrea Renninger, MS
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Jennifer Dickey, PhD, RAC
•
Ana Trullás Jimeno, PharmD, MSc
CDER
CDRH
Combination products/companion diagnostics
Europe
European Medicines Agency (EMA)
Product development
United States
US Food and Drug Administration (FDA)