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
01:55 – Selective Safety Data Collection in Clinical Trials
29:59 – Q&A Session
44:45 – Enhancing Clinical Trial Innovation
01:10:29 – Q&A Session
Speakers:
Mary T. Thanh Hai, MD
Deputy Director for Clinical
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER) | FDA
Kevin Bugin, PhD, MS, RAC
Deputy Director
OND | CDER | FDA
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