Excellence in Review Science–GROUP
This category recognizes a group involved in a review science collaborative effort which includes, but is not limited to, 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. Laboratory- based accomplishments are not eligible for this award.
2023
Botanical Review Team (CDER)
For providing a novel comparative review of state level cannabis quality testing and cGMPs, resulting in rapid publication and extremely valuable commentary to the field.
Schuyler Pruyn, M.S.
Cassandra Taylor, Ph.D.
Charles Wu, Ph.D.
Qiang Wang, Ph.D.(Staff Fellow)
2022
Statistical Team Supporting Drug Trials Snapshots, Complex and Innovative Design, and Pediatric Drug Development (CDER)
For outstanding contribution to support new legal requirements to clarify impact of demographic differences on drug efficacy and to expedite drug development with innovative design
Mark Rothmann, PhD
Robert Abugov, MPH, PhD
James Travis, PhD
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.
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