Скачать с ютуб Planning for Co-development of Companion Diagnostics в хорошем качестве

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... --------------------  FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.   Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry...   SBIA LinkedIn:   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected]   Phone - (301) 796-6707 I (866) 405-5367