Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 - Session 2

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
01:01 - AI in Drug Development
30:36 - Q&A Session
40:09 - ClinicalTrials.gov: Meeting Transparency and Reporting Requirements
01:15:11 - Q&A Session
Speakers:
Tala Fakhouri, PhD, MPH
Associate Director for Policy Analysis
Office of Medical Policy (OMP)
Center for Drug Evaluation and Research (CDER) | FDA
Laurie Muldowney, MD
Deputy Director
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
CDER | FDA
Learn more at: www.fda.gov/dr...
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