Overcoming the Challenges of Conducting Early Feasibility Studies of Medical Devices in the United States
Holmes, David R., MD, Califf, Robert, MD, Farb, Andrew, MD, Abel, Dorothy, BSBME, Mack, Michael, MD, Syrek Jensen, Tamara, JD, Zuckerman, Bram, MD, Leon, Martin, MD, Shuren, Jeff, MD
Published in Journal of the American College of Cardiology (25.10.2016)
Published in Journal of the American College of Cardiology (25.10.2016)
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Journal Article
Clinical Perspective—Early Feasibility Device Medical Studies in the United States
Holmes, David R., MD, Shuren, Jeff, MD, Califf, Robert, MD, Zuckerman, Bram, MD, Abel, Dorothy, BSBME, Farb, Andrew, MD, Leon, Martin, MD, Mack, Michael, MD
Published in JACC. Cardiovascular interventions (01.03.2016)
Published in JACC. Cardiovascular interventions (01.03.2016)
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Journal Article
Overcoming the Challenges of Conducting Early Feasibility Studies of Medical Devices in the United States: Review Topic of the Week
Holmes, David R, Califf, Robert, Farb, Andrew, Abel, Dorothy, Mack, Michael, Syrek Jensen, Tamara, Zuckerman, Bram, Leon, Martin, Shuren, Jeff
Published in Journal of the American College of Cardiology (01.10.2016)
Published in Journal of the American College of Cardiology (01.10.2016)
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Journal Article
The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices
Holmes, David R., Hance, Robert, Syrek Jensen, Tamara S., Schwartz, Daniel A., Kaplan, Aaron, Farb, Andrew, Zuckerman, Bram, Leon, Martin, Waklowiak, Jamie, Mack, Michael J., Shuren, Jeff
Published in JACC. Cardiovascular interventions (12.11.2018)
Published in JACC. Cardiovascular interventions (12.11.2018)
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Journal Article
Transcatheter valve therapy registry is a model for medical device innovation and surveillance
Carroll, John D, Shuren, Jeff, Jensen, Tamara Syrek, Hernandez, John, Holmes, David, Marinac-Dabic, Danica, Edwards, Fred H, Zuckerman, Bram D, Wood, Larry L, Kuntz, Richard E, Mack, Michael J
Published in Health Affairs (01.02.2015)
Published in Health Affairs (01.02.2015)
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Journal Article
The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices: What Have We Learned, Where Do We Need to Go?
Holmes, Jr, David R, Hance, Robert, Syrek Jensen, Tamara S, Schwartz, Daniel A, Kaplan, Aaron, Farb, Andrew, Zuckerman, Bram, Leon, Martin, Waklowiak, Jamie, Mack, Michael J, Shuren, Jeff
Published in JACC. Cardiovascular interventions (12.11.2018)
Published in JACC. Cardiovascular interventions (12.11.2018)
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Journal Article
Clinical Perspective—Early Feasibility Device Medical Studies in the United States: Time for More Than Regulatory Reform
Holmes, David R., Shuren, Jeff, Califf, Robert, Zuckerman, Bram, Abel, Dorothy, Farb, Andrew, Leon, Martin, Mack, Michael
Published in JACC. Cardiovascular interventions (28.03.2016)
Published in JACC. Cardiovascular interventions (28.03.2016)
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Journal Article
Stand with science to protect health: FDA leaders: Following facts helps in pandemic
Cavazzoni, Patrizia, Marks, Peter, Mayne, Susan, McMeekin, Judy, Shuren, Jeff, Solomon, Steven, Woodcock, Janet, Zeller, Mitch
Published in The clarion-ledger (20.09.2020)
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Published in The clarion-ledger (20.09.2020)
Newspaper Article
Career FDA leaders: We stand with science to protect health
Cavazzoni, Patrizia, Marks, Peter, Mayne, Susan, McMeekin, Judy, Shuren, Jeff, Solomon, Steven, Woodcock, Janet, Zeller, Mitch
Published in Springfield News Leader (12.09.2020)
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Published in Springfield News Leader (12.09.2020)
Newspaper Article
Senior FDA career executives: We're following the science to protect public health in pandemic
Patrizia Cavazzoni; Peter Marks; Susan Mayne; Judy McMeekin; Jeff Shuren; Steven Solomon; Janet Woodcock; Mitch Zeller; Opinion contributors
Published in USA today.com (10.09.2020)
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Published in USA today.com (10.09.2020)
Newspaper Article