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Past FDA Visitors
2018 FDA Visitors
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Dates |
Topics |
Visitors |
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January 24-26, 2018 |
Genomic Medicine |
Brittany Schuck, PhD | Senior Staff Fellow, Division of Chemistry and Toxicology Devices, OIR/CDRH
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May 15-17, 2018 |
Pediatric Medical Devices |
Vasum Peiris, MD | Chief Medical Officer – Pediatrics and Special Populations/CDRH
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June 18-20, 2018 |
Patient Engagement |
Heather Benz, PhD | Biomedical Engineer, Office of Science and Engineering Laboratories/CDRH
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June 20, 2018 |
Reimagining the Medical Device Oversight Paradigm |
Jeffrey Shuren, MD, JD | Director, Center for Devices and Radiological Health
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June 21-22, 2018 |
Blood Safety and Pathogen Detection |
Sanjai Kumar, PhD | Chief, Laboratory of Emerging Pathogens/CBER
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Jul 30-Aug 1, 2018 |
Computational Science Slides: |
Lilliam Rosario, PhD | Director, Office of Computational Science/CDER
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September 20-21, 2018 |
Viral Detection |
Indira Hewlett, PhD | Chief, Laboratory of Molecular Virology/CBER
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November 8-9, 2018 |
Regenerative Medicine Slides: |
Kyung Sung, PhD | Principal Investigator/Reviewer, Division of Cellular and Gene Therapies/CBER
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2017 FDA Visitors
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Dates |
Topics |
Visitors |
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March 20-22, 2017
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Trends in Regulatory Science
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Frank Weichold, MD, PhD | Director, Critical Path and Regulatory Science Initiatives, Office of the Chief Scientist
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March 29, 2017
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Pharmacovigilence
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Robert Ball, MD | Deputy Director, Office of Surveillance and Epidemiology, CDER
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April 19-20, 2017
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Rare Diseases and Gene Therapies Slides: |
Ilan Irony, MD | Deputy Director, Division of Clinical Evaluation and Pharmacology/Toxicology/OTAT, CBER
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May 11-12, 2017
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Biostatistics
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Rajeshwari Sridhara, PhD | Director, Division of Biometrics V, Office of Biostatistics, CDER
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June 5-9, 2017
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Medical Devices and Patient Preference
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Heather Benz, PhD | Medical Device Fellow, External Expertise and Partnerships, CDRH
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September 20-22, 2017
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Personalized Medicine and Molecular Genetics
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David Litwack, PhD | Personalized Medicine Staff/OIR, CDRH
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October 2-3, 2017
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Gene Editing and Gene Therapy Products Slides: |
Ying Huang, PhD | Pharmacologist, Division of Clinical Evaluation & Pharmacology/Toxicology/OTAT, CBER
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November 15-16, 2017 |
Cellular Immunotherapies Slides: |
Kristin Baird, MD | Medical Officer, Division of Clinical Evaluation & Pharmacology/Toxicology/OTAT, CBER
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2016 FDA Visitors
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Dates |
Topic |
Visitors |
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April 18-22, 2016 |
Patient Preference |
Heather Benz, PhD | Medical Device Fellow, External Expertise and Partnerships, CDRH
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May 10-11, 2016 |
Clinical Pharmacology |
Issam Zineh, PharmD, MPH | Director, Office of Clinical Pharmacology, CDER
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May 19/25, 2016 |
FDA Commissioner |
Robert Califf, MD | Commissioner of Food and Drugs
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July 5-6, 2016 |
Next-Generation Sequencing and the FDA HIVE Architecture Recordings: Eric Donaldson and Vahan Simonyan |
Eric F. Donaldson, PhD | Virology Reviewer, Division of Antiviral Products, CDER
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August 1-2, 2016 |
App-Based Safety Surveillance for Generic Drugs Slides: |
Liang Zhao, PhD | Director, Division of Quantitative Methods and Modeling/OGD, CDER
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August 23-25, 2016 |
Radiation Therapy and Biomedical Imaging Devices Recordings: Robert Ochs, Michael O'Hara, Nicholas Petrick and Daniel Krainak |
Robert Ochs, PhD | Director, Division of Radiological Health, CDRH
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September 13-14, 2016 |
Excipients in Generic Drugs |
Xinyuan (Susie) Zhang, PhD | Staff Fellow, Division of Quantitative Methods and Modeling/OGD, CDER
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September 26-27, 2016
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Stem Cells and Computational Modeling Recordings: David Strauss, Wendy Wu, Zhihua Li, Ksenia Blinova, Robbert Zusterzeel, Darrell Abernethy |
David Strauss, MD, PhD | Acting Director, Division of Applied Regulatory Science/OCP, CDER
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October 24-25, 2016 |
Genomics and Targeted Therapies Recording: Anuradha Ramamoorthy |
Michael Pacanowski, PharmD, MPH | Associate Director for Genomics and Targeted Therapy/OCP, CDER
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October 27-28, 2016
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Office of the Chief Scientist
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Frank Weichold, MD, PhD | Director, Critical Path and Regulatory Science Initiatives, Office of the Chief Scientist
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November 16-18, 2016
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Stem-Cell Based Product Characterization and Regulatory Science
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Steven R. Bauer, PhD | Chief, Cellular and Tissue Therapy Branch, CBER
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2015 FDA Visitors
| Dates | Topic | FDA Visitors |
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April 2-3, 2015 |
Characterizing Cell Populations Recordings: Carolyn Wilson, Malcolm Moos and Steven Bauer |
Carolyn A. Wilson, PhD | Associate Director for Research, CBER
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April 22-23, 2015 |
Medical Device Regulation |
Elias Mallis | Director of Industry and Consumer Outreach, CDER
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May 18-19, 2015 |
Therapeutic Equivalence in Generic Drug Review Recordings: Robert Lionberger
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Robert Lionberger, PhD | Director, Office of Research and Standards/OGD, CDER
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August 17-21, 2015 |
An FDA Roadmap for Medical Devices Recordings: Malvina Eydelman
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Malvina B. Eydelman, MD | Director, Division of Ophthalmic and Ear, Nose and Throat Devices, CDRH
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August 26-27, 2015 |
Data Science |
Taha Hass-Hout, MD, MS | Chief Health Informatics Officer, Office of Informatics & Technology Innovation
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August 25, 2015 |
Development & Approval of Rapid Diagnostics and Measures for Viral Outbreaks Recordings: Cynthia Kelley and Sally Hojvat |
Sally A. Hojvat, PhD, MSc | Former Director, Division of Microbiology Devices/OIR, CDRH
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September 3, 2015 |
Modeling and Simulation in the Development and Approval of Drugs Recordings: Vikram Sinha |
Vikram Sinha, PhD | Senior Advisor for Regulatory Program and Policy, Office of Clinical Pharmacology, CDER
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September 23-24, 2015 |
Regulatory and Scientific Challenges for Drug-drug Interactions Recordings: Shiew-Mei Huang and Lei Zhang |
Shiew-Mei Huang, PhD | Deputy Director, Office of Clinical Pharmacology, CDER
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September 24-25, 2015 |
Next-Generation Sequencing Recordings: Marc Salit and E. David Litwack |
Elizabeth Mansfield, PhD | Director for Personalized Medicine and Molecular Genetics, Office of In Vitro Diagnostics and Radiological Health, CDRH
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September 28-30, 2015 |
Patient Preferences in Medical Device Approval |
Anindita Saha | Director, External Expertise and Partnerships, CDRH
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