Our statisticians conduct independent research on statistical methodologies relevant to CDER’s scientific mission and regulatory review process. Our research spans such broad areas as clinical trial design, Bayesian statistics, signal detection, causal inference, meta-analysis, bioequivalence, benefit-risk assessment, … See more Mark Rothmann, Ph.D., Director Yun Wang, Ph.D., Deputy Director Focuses on the development and regulatory evaluation of: 1. Cardiology and … See more James Hung, Ph.D., Director Sue Jan Wang, Ph.D., Deputy Director Focuses on the development and regulatory evaluation of: 1. Anesthesia, Analgesia, and Addiction Products 2. Neurology Products 3. Psychiatric … See more Laura Lee Johnson, Ph.D., Director Vacant, Deputy Director Focuses on the development and regulatory evaluation of: 1. Dermatology and Dentistry Products 2. Gastroenterology … See more WebMar 16, 2024 · This is a Virtual Pre-Conference Short Course in conjunction with the DIA/FDA Biostatistics Industry and Regulator Forum. ... Drug Information Association (DIA) is accredited by the International Accreditors for Continuing Education and Training (IACET) and offers IACET CEUs for its learning events that comply with the ANSI/IACET …
Richard Forshee - Deputy Director, Office of Biostatistics and ...
WebApr 11, 2024 · In the latest issue of New England Journal of Medicine, Drs Ross, Berg, and Ramachandran wrote a paper: "Ensuring Public Trust in an Empowered FDA". The paper discussed the recent trend that FDA is … WebApr 1, 2024 · We provide updated estimates for the duration of clinical trials using our data set. We find that the median clinical trial durations are 1.6, 2.9, and 3.8 years, for trials in … dato‘ syed mohd razif bin syed yasin
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WebDialogue with the New FDA/CDRH Biostatistics Division Director, Dr. Gregory Alexander Co-organizers: Cristiana Mayer, Johnson & Johnson Vision Vicki Petrides, Abbott, Inc. Arianna Simonetti, FDA Jack Zhou, FDA Speakers: Dr. Gregory Alexander, FDA Hope Knuckles, Abbott, Inc. Xiao-Yu Song, Johnson & Johnson Vision FDA Invited: 5:00 pm – … WebTitle: Targeted Learning and Causal Inference for Integrating Real World Evidence into the Drug Approval Process and Safety Analysis. Abstract: Targeted Learning represents a general multi-step roadmap for accurately translating the real world into a formal statistical estimation problem, and a corresponding template for construction of optimal machine … Webbiostatistics: [noun, plural in form but singular in construction] statistical processes and methods applied to the collection, analysis, and interpretation of biological data and … bju live street cameras