UMB P.I.s and CP Co-PI: Daniel Mullins, PhD and Philip Resnik, PhD
FDA Collaborator: Christine Lee, Pharm D, PhD

Project Description and Goals


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CERSI P.I. and Collaborator: University of Maryland: Catherine E. Cooke (PI), PharmD, MS, Raymond C. Love, PharmD and Megan Ehret, PharmD, MS

FDA Collaborators: Gita A. Toyserkani (PI), PharmD, MBA, Esther Zhou (Co-PI), MD, PhD, Barbara Bergquist, PharmD, Leah Hart, PharmD, Kate Heinrich, MA, and Cynthia LaCivita, PharmD

Regulatory Science Challenge


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CERSI P.I.: Sarah Michel, Ph.D, UMB School of Pharmacy

FDA SME and Collaborators: Vyomesh Patel, Ph.D., CTP

Regulatory Science Challenge

Researchers will also analyze ENDS hardware, e-liquids (including color and ingredients), and the constituents of the complex aerosol for each ENDS category evaluated. All data collected will be compiled into a database that may help to inform the regulatory decision-making process. Project findings may inform future regulatory activities related to ENDS. 


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CERSI P.I. and Collaborator: C. Daniel Mullins, Ph.D., Professor and Chair, Department of Pharmaceutical Health Services Research UMB, Cynthia Baur, Ph.D., University of Maryland, College Park
FDA SMEs and Collaborators: Michelle Tarver, MD, Ph.D., FDA CDRH, Jessica Weinberg, MPP, CDRH/OST, Jose Medina-Torres, DrPH, MPH, CHES, CDRH/OCE

 

Regulatory Science Challenge


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CERSI P.I.s and Collaborators: Zafar Zafari, M.Sc., Ph.D., (Principal Investigator), Susan dosReis, Ph.D. (co-Investigator), Chintal H. Shah, MS, Jeong-eun Park, MPH, Emily Gorman, MLIS, AHIP, University of Maryland Baltimore 
FDA SMEs and Collaborators: Fang Tian, Ph.D., MPH, MHS, Wei Hua, MD, Ph.D., Rita Ouellet-Hellstrom, Ph.D., MPH, Yong Ma, Ph.D., MS 
 
Regulatory Science Challenge

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CERSI P.I. and Collaborator: Paul W. Buehler, PharmD, Ph.D., UMB School of Medicine
FDA SMEs and Collaborators: Julia Pinto, Ph.D., CDER FDA, Xiaoming Xu, Ph.D., CDER FDA, Jin Hyen Baek, Ph.D., CBER FDA
 

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CERSI P.I. and Collaborator: Taylor Woehl, Ph.D., UMCP Department of Chemical and Biomolecular Engineering
FDA SMEs and Collaborators: Bin Qin, Ph.D., CDER FDA, Yan Wang, Ph.D., CDER FDA, Stephanie Choi, Ph.D., CDER, FDA
 

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CERSI P.I.s and Collaborators: Danya Qato, PharmD, MPH, Ph.D., UMB School of Medicine, Bethany DiPaula, PharmD UMB School of Pharmacy, Megan J. Ehret, PharmD, MS, UMB School of Pharmacy
FDA SMEs and Collaborators: Sara Eggers, Ph.D., CDER, FDA, Reza Kazemi-Tabriz, Ph.D., CDER FDA

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CERSI P.I. and Collaborator: Hongbing Wang, Ph.D., UMB School of Pharmacy
FDA SME and Collaborator: Shiew-Mei Huang Ph.D., CDER, FDA
 

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CERSI P.I. and Collaborator: Mohummad Minhaj Siddiqui, MD UMB School of Medicine
FDA SME and Collaborator: Charles Viviano, MD, Ph.D. CDRH, FDA
 

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