This presentation discussed a rundown of the Do’s and Don’ts from FDA’s Oncology Center of Excellence (OCE).
Timestamps
01:37 – Do’s and Don’ts
04:37 – The One Imperative Action
05:32 – How to Accomplish That Task
08:20 – Engage
09:48 – Summary
Speaker:
Jeff Summers, MD
Associate Office Director
Office of Oncologic Diseases (OOD)
Office of New Drugs (OND | CDER
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/fda-nih-regulatory-dos-and-donts-tips-fda-09042024
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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/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - https://www.youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA 2025 Playlist - https://www.youtube.com/playlist?list=PLey4Qe-Uxcxa5NzgN2UeQcHqklugEvBje
SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - https://twitter.com/FDA_Drug_Info
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367
Timestamps
01:37 – Do’s and Don’ts
04:37 – The One Imperative Action
05:32 – How to Accomplish That Task
08:20 – Engage
09:48 – Summary
Speaker:
Jeff Summers, MD
Associate Office Director
Office of Oncologic Diseases (OOD)
Office of New Drugs (OND | CDER
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/fda-nih-regulatory-dos-and-donts-tips-fda-09042024
-----------------------
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/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - https://www.youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA 2025 Playlist - https://www.youtube.com/playlist?list=PLey4Qe-Uxcxa5NzgN2UeQcHqklugEvBje
SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - https://twitter.com/FDA_Drug_Info
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367
- Categoria
- Oncology
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