FDA Clinical Investigator Training Course (CITC) 2023, Day 1

FDA Clinical Investigator Training Course (CITC) 2023, Day 1 - Part 2

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This course was designed to promote professionalism in the clinical trial industry for individuals involved with submissions to FDA (Investigational New Drug (IND) application, New Drug Application (NDA), Biologics License Application (BLA)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical drugs and biological products.
Timestamps
00:02 - Trial Design Considerations in Rare Diseases
27:24 - Specific Populations in Clinical Trials
57:49 - Q&A Discussion Panel
Speakers | Panelists:
Scott Winiecki, MD
Lead Physician
Rare Diseases Team (RDT)
Division of Rare Diseases and Medical Genetics (DRDMG)
Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORDPURM)
Office of New Drugs (OND)
CDER | FDA
Lynne Yao, MD
Director
Division of Pediatric and Maternal Health (DPMH)
ORDPURM | OND | CDER | FDA
Moderator:
Leonard Sacks, MBBCh
Associate Director for Clinical Methodologies
Office of Medical Policy (OMP)
CDER | FDA
Learn more at: www.fda.gov/dr...
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