CMC Considerations for CAR T Cell Product Development
11.6 هزار بار بازدید -
3 سال پیش
-
FDA discusses the CMC requirements
FDA discusses the CMC requirements for CAR T Cell Product IND submissions, including early product development and product characterization for both autologous and allogenic products.
Presenter:
Kimberly Schultz, PhD, Gene Therapy Reviewer, Division of Cellular & Gene Therapies, Office of Tissues and Advanced Therapies (OTAT), CBER
Learn more at: https://www.fda.gov/drugs/news-events...
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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: LinkedIn: cder-small-business-and-industry-assistance
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - Twitter: FDA_Drug_Info
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367
Presenter:
Kimberly Schultz, PhD, Gene Therapy Reviewer, Division of Cellular & Gene Therapies, Office of Tissues and Advanced Therapies (OTAT), CBER
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: LinkedIn: cder-small-business-and-industry-assistance
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - Twitter: FDA_Drug_Info
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367
3 سال پیش
در تاریخ 1400/01/26 منتشر شده
است.
11,602
بـار بازدید شده