U.S. Food and Drug Administration | Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 3 @US_FDA | Uploaded 3 weeks ago | Updated 1 hour ago
Content in this video provided updates and cutting-edge insight on novel artificial intelligence (AI), clinical trial designs and innovative strategies, safety data in clinical trials, combination products, electronic submissions and more. Subject matter experts provided insight on FDA’s perspectives, adoption of regulatory guidelines, opportunities for stakeholders to engage with CDER and best practices.
Timestamps
00:37 – Diversity in Clinical Trials: Drug Trials Snapshot Perspective
21:11 – Q&A Session
32:42 – Combination Products – Updates and Best Practices
01:03:23 – Q&A Session
Speakers:
Aden S. Asefa, MPH
Drug Trials Snapshot Lead
Office of Drug Evaluation Sciences (ODES)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER) | FDA
Kristina Lauritsen, PhD
Combination Product Regulatory Advisor
Product Jurisdiction and Combo Product Team
Office of Executive Programs (OEP)
CDER | FDA
Learn more at: fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development
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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 - fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - fda.gov/cdersbialearn
Twitter - twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
Content in this video provided updates and cutting-edge insight on novel artificial intelligence (AI), clinical trial designs and innovative strategies, safety data in clinical trials, combination products, electronic submissions and more. Subject matter experts provided insight on FDA’s perspectives, adoption of regulatory guidelines, opportunities for stakeholders to engage with CDER and best practices.
Timestamps
00:37 – Diversity in Clinical Trials: Drug Trials Snapshot Perspective
21:11 – Q&A Session
32:42 – Combination Products – Updates and Best Practices
01:03:23 – Q&A Session
Speakers:
Aden S. Asefa, MPH
Drug Trials Snapshot Lead
Office of Drug Evaluation Sciences (ODES)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER) | FDA
Kristina Lauritsen, PhD
Combination Product Regulatory Advisor
Product Jurisdiction and Combo Product Team
Office of Executive Programs (OEP)
CDER | FDA
Learn more at: fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development
-----------------------
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 - fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - fda.gov/cdersbialearn
Twitter - twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
