Collaborators
FDA Collaborators
Collaborating on: Effectiveness research with Real World Data to support FDA’s regulatory decision making:
A Real World Evidence demonstration project and Predicting findings of ongoing Phase 4 RCTs with Real World Data analyses: An assessment to support FDA's regulatory decision making
A Real World Evidence demonstration project and Predicting findings of ongoing Phase 4 RCTs with Real World Data analyses: An assessment to support FDA's regulatory decision making
Dianne Paraoan, MD,MPH
Associate Director for Regulatory Affairs
Associate Director for Regulatory Affairs
Robert Temple, MD
CDER’s Deputy Center Director for Clinical Science;
Acting Deputy Director of the Office of Drug Evaluation I (ODE-I)
CDER’s Deputy Center Director for Clinical Science;
Acting Deputy Director of the Office of Drug Evaluation I (ODE-I)
David Martin, MD, MPH
Associate Director for Real World Evidence Analytics
Associate Director for Real World Evidence Analytics
Mark Levenson, PhD
Director of the Division of Biometrics VII
Director of the Division of Biometrics VII
Rongmei Zhang, PhD
Statistician, Office of Biostatistics, Office of Translational Science
Statistician, Office of Biostatistics, Office of Translational Science
Hana Lee, PhD
Statistician, Office of Biostatistics, Office of Translational Science
Statistician, Office of Biostatistics, Office of Translational Science
Robert Ball, MD
Deputy Director, Office of Surveillance and Epidemiology
Deputy Director, Office of Surveillance and Epidemiology
Natasha Pratt, MHA, PhD
Senior Epidemiologist, Office of Surveillance and Epidemiology
Senior Epidemiologist, Office of Surveillance and Epidemiology
Marie Bradley, PhD
Epidemiologist, Office of Surveillance and Epidemiology
Epidemiologist, Office of Surveillance and Epidemiology
Christine Nguyen, MD
Deputy Director for Safety, Division of Bone, Reproductive, and Urologic Products, Office of New Drugs (OND)
Deputy Director for Safety, Division of Bone, Reproductive, and Urologic Products, Office of New Drugs (OND)
Mary Ross Southworth, PharmD
Deputy Director for Safety, Division of Cardiovascular and Renal Products, Office of New Drugs (OND)
Deputy Director for Safety, Division of Cardiovascular and Renal Products, Office of New Drugs (OND)
Tzu-Yun McDowell, PhD
Clinical Analyst, Division of Cardiovascular and Renal Products, Office of New Drugs (OND)
Clinical Analyst, Division of Cardiovascular and Renal Products, Office of New Drugs (OND)
Nicole Gormley, MD
Deputy Division Director, Division of Hematologic Products, Office of New Drugs (OND)
Deputy Division Director, Division of Hematologic Products, Office of New Drugs (OND)
Albert Deisseroth, MD, PhD
Associate Division Director, Division of Hematologic Products, Office of New Drugs (OND)
Associate Division Director, Division of Hematologic Products, Office of New Drugs (OND)
Lisa Yanoff, MD
Director (Acting), Division of Metabolic and Endocrine Products, Office of New Drugs (OND)
Director (Acting), Division of Metabolic and Endocrine Products, Office of New Drugs (OND)
William Chong, MD
Deputy Director (Acting), Division of Metabolic and Endocrine Products, Office of New Drugs (OND)
Deputy Director (Acting), Division of Metabolic and Endocrine Products, Office of New Drugs (OND)
Robert Busch, MD, MMSc
Medical Officer, Division of Pulmonary, Allergy, and Rheumatologic Products, Office of New Drugs (OND)
Medical Officer, Division of Pulmonary, Allergy, and Rheumatologic Products, Office of New Drugs (OND)
Rekha Jhamnani, MD
Medical Officer, Division of Pulmonary, Allergy, and Rheumatologic Products, Office of New Drugs (OND)
Medical Officer, Division of Pulmonary, Allergy, and Rheumatologic Products, Office of New Drugs (OND)
Ken Quinto, MD
Medical Officer, Office of Medical Policy
Medical Officer, Office of Medical Policy
Vojtech Huser, MD
Medical Officer, Office of Medical Policy
Medical Officer, Office of Medical Policy
