FDA Clinical Investigator Training Course (CITC) 2022, Day 1 - Part 3

This course was designed to promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products.
Timestamps
01:00 - Gene Therapy
22:46 - CarT Therapy
38:23 - International Clinical Trials
57:43 - Q&A Session 3
Speakers:
Lei Xu, MD., PhD
Branch Chief
General Medicine Brach 2 (GMB2)
Division of Clinical Evaluation & Pharmacology/Toxicology (DCEPT)
Office of Tissues and Advanced Therapies (OTAT) | CBER | FDA
Lianne Hu, MD., PhD., MPH, MS
Clinical Analyst
DCEPT | OTAT | CBER | FDA
Kassa Ayalew, MD., MPH
Branch Chief
Division of Clinical Compliance Evaluation (DCCE)
Office of Scientific Investigations (OSI)
CDER | FDA
Panelists:
Lei Xu, Lianne Xu, Kassa Ayalew
and
Leonard Sacks, MBBCh
Associate Director
Clinical Methodologies | Office of Medical Policy (OMP)
CDER | FDA
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