Review science includes new and/or uniquely applied approaches to regulatory decision-making and ability to interpret scientific information submitted to the Agency, e.g., application of scientific expertise to the review process, national and international standards development and harmonization, development of regulatory policies and guidance, etc.

2021

OFAS/DFCS PFAS Team (CFSAN)

The OFAS/DFCS PFAS review team's scientific review on short-chain PFAS has led the FDA to take the lead to protect public health.

 

Penelope Rice, PhD, DABT

Shruti Kabadi, PhD

Jessica Cooper

Sharon Koh-Fallet, PhD

 

2020

Fentanyl Reservoir Transdermal System (TDS) Reference Report Team

For providing the scientific foundation to remove reservoir Fentanyl Transdermal Systems from the US market and answering a Citizen's Petition submitted in 2005.

 

Caroline Strasinger, PhD

Cedar Boakye, PhD (Staff Fellow)

Anna Wokovich

Alicia Hoover, PhD

 

2019

MRI Compatibility Review Group

For sustained efforts to improve MRI labeling for all medical devices and in particular, for MR-Conditional devices.

 

Devashish Shrivastava, PhD

Finn Donaldson, PhD

Brent Showalter, PhD

Nicole Larsen, MME

Vasant Dasika, PhD

Daniel Krainak, PhD, MS

Samuel Raben, PhD

Amir Razjouyan, MS

David Soltysik, PhD

Donald Witters, MS

Eriko Yoshimaru, PhD

Howard Bassen, MS

Jana Delfino, PhD

Leornardo Angelone, PhD

Sunder Rajan, PhD

Ting Song, PhD, MPhil

Terry Woods, PhD, MS

Wilfgant Kainz, PhD, MS

 

2018

Emerging Technology Team

The Office of Pharmaceutical Quality Emerging Technology Team provides leadership in promoting and facilitating the development and implementation of innovative pharmaceutical product and manufacturing technologies to advance product quality, safety and efficacy.

 

Geoffrey Wu, PhD (C)

Kurt A Brorson, PhD

Rick Friedman, MS

Celia N. Cruz, PhD

Min Li, PhD

Thomas Francis O’Connor, PhD

Rapti D. Madurawe, PhD

Mohan Sapru, PhD

Mahesh Ramanadham, PharmD, MBA

Bryan Riley, PhD

Cheryl Kaiser, MA

Sharmista Chatterjee, PhD

Juandria Williams, PhD

Tara Gooen Bizjak, M.NmSCI (C)

Sau L. Lee, PhD

 

2017

Zika Virus Review Team

For the timely application of collaborative scientific review expertise in the face of a national public health emergency caused by the emerging Zika virus threat.

 

J. Peyton Hobson, PhD
David A. Leiby, PhD
Pradip N. Akolkar, PhD

 

2016

Zarxio Review Team

For scientific innovation, excellence in regulatory review, and highest level of collaboration and
teamwork leading to the first FDA approved bio similar product, Zarxio

 

Monsurat Lara Akinsanya, MS;  Kassa Ayalew, MD, MPH;  Jibril Bin Mikail Abdus-Samad, PharmD;  Jessica Boehmer, MBA;  Theresa Carioti, MPH

 

Nathan Caulk, MS, BSN (C); Bo Chi, MD, PhD; Haw-Jyh Chiu, PhD; Lea Christl, PhD; Albert Deisseroth, MD, PhD

 

Marlene Schultz-DePalo, MS, MA; Xiaoyu Dong, PhD; Ann Farrell, MD; Steven Fong, PhD; Barbara Fuller, MSN, BSN

 

CAPT Patricia Garvey, RPh (C); Adam George, PharmD; Nicole Gormley, MD; LaShawn Griffiths, MSHS-PH, BSN

 

Thomas Gwise, PhD; Gregory H. Reaman, MD; Sam Haidar, PhD, RPh; Sarah Harris, PharmD; Patricia Hughes, PhD

 

Gibbes Johnson, PhD; Edvardas Kaminskas, MD; Susan Kirshner, PhD; Steven Kozlowski, MD;Virginia Kwitkowski, MS, ACNP-BC

Emanuela Lacana, PhD; Carla Lankford, MD, PhD; Maria-Teresa Gutierrez-Lugo, PhD; John Leighton, PhD; Sue Lim, MD

Christopher M. Sheth, PhD;  Anshu Marathe, PhD;  Yelena Maslov, PharmD;  Ryan McGowan; Lubna Merchant, MS, PharmD

Frederick Mills, PhD; Tyree Newman; Lei Nie, PhD; Anthony Orencia, MD; Neel Patel, PharmD

Zhihao Peter Qiu, PhD; Janice Pohlman, MD, MPH;  Ranjani Prabhakara, PhD;  Donna Przepiorka, MD, PhD;  Nama Rahman, PhD

Sripal Reddy Mada, PhD;  Haleh Saber, PhD; Sarah, Schreiber, PharmD;  Faruk Sheikh, PhD;  Meiyu Shen, PhD; 

Vikram Sinha, PhD;  Michael Skelly, PhD;  Rajeshwari Sridhara, PhD;  Alan Stevens, ME; Kellie Taylor, PharmD, MPH

Yi Tsong, PhD; Sonal Vaid, JD; Neil Vora, PharmD, MBA;  Janice Weiner, JD, MPH;  Kyung Yul Lee, PhD 

 

2015

Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs Development Group, CDER

For the development of an innovative bioequivalence approach to evaluate generic narrow therapeutic index drugs.

 

Mei-Ling Chen, PhD
Dale Conner, PharmD
Wenlei Jiang, PhD
Fairouz Makhlouf, PhD
Laurie Muldowney, MD
Robert Lionberger, PhD
Donald Schuirmann, PhD
Lawrence X Yu, PhD
Xinyuan Zhang, PhD
Nan Zheng, PhD

 

2014

Center for Devices and Radiological Health (CDRH) EMC and Wireless Work Group

For outstanding scientific vision, leadership, and public health impact in the development and publication of the Radio Frequency Wireless Technology in Medical Devices Guidance document.

 

Heather Agler, PhD, CDRH
Vasant K. Dasika, PhD, CDRH
Eva Ellsworth, CDRH
Charles Ho, PhD, CDRH
George Kraus, CDRH
Bakul Patel, MBA, CDRH
Nancy Pressly, MS, CDRH
Linda Ricci, MS, CDRH
Seth Seidman, MSEE, CDRH
Jeffrey L. Silberberg, MSEE, CDRH
Linda Weir
Donald M. Witters, MS, CDRH

 

2013

Bioabsorbable Group

For excellence in review science of the bioabsorbable materials and their complexities in cardiovascular stent applications.

 

Ji Guo, Ph.D., CDRH
Nicholas Benetatos Ph.D., CDRH
Maureen Dreher Ph.D., CDRH 

 

2012

The Finasteride and Dutasteride Review Team, OHOP/OND/CDER

For outstanding assessments of the risk-benefit ratio of 5A-reductase inhibitors with regard to proposed use of prevention of prostate cancer in men

 

John R. Johnson, M.D., CDER
Marc Theoret, M.D., CDER
Yang-Min Ning, M.D., Ph.D., CDER
Jenny Zhang, Ph.D., CDER
Kun He, Ph.D., CDER
Chia-Wen Ko, Ph.D., CDER
Shenghui Tang, Ph.D., CDER

 

2011

CFSAN/OFAS Trans Fat Intake Assessment Work Group

For development of an updated intake estimate of trans fat in the diet and regulatory options to address further reduction of trans fat in the diet

 

Diana I. Doell, Ph.D.
Daniel E. Folmer, Ph.D.
Mical E. Honigfort, Ph.D.
Hyoung S. Lee, Ph.D.

 

2010

Hematopoietic Stem/Progenitor Cell Task Group, CBER

For outstanding collaborative analysis of data submitted to a public docket in a precedent-setting leveraging activity to develop licensure criteria for cord blood

 

Tami Belouin, J.D.
Kimberly Benton, Ph.D.
Peter Bross, M.D.
Changting Haudenschild, M.D.
CAPT. Ellen F. Lazarus, M.D.
Laurie Norwood
Mercy Quagraine
Donna Przepiorka, M.D.
Anita Richardson
Chinying Wang
Denise Zavagno, J.D.

 

2009

Generic Calcitonin Review Group, CDER

For developing a novel, science-based regulatory pathway to evaluate and approve high quality, safe and effective generic salmon calcitonin.

 

Raj Bykadi, PhD
Bing Cai, PhD
Barry W. Cherney, PhD
Dale P. Conner, PhD
Barbara M. Davit, PhD
Kuldeep R. Dhariwal, PhD
Devinder S. Gill, PhD
Wei Guo, PhD
Sau L. Lee, PhD
Benjamin B. Lim, PhD
Shing H. Liu, PhD
Moheb H. Makary, PhD
Rashmikant Patel, PhD
Andre S. Raw, PhD
Amy S. Rosenberg, MD
Vilayat A. Sayeed, PhD
Paul Schwartz, PhD
Lawrence X. Yu, PhD