Publications by authors named "Tamy Kim"

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US Food and Drug Administration Approval Summary: Ribociclib With an Aromatase Inhibitor in the Adjuvant Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Stage II and III High-Risk Early Breast Cancer Treatment Setting.
Jennifer J Gao, Tatiana M Prowell, Haley Gittleman, Joyce Cheng, Mallorie Fiero, Tamy Kim

J Clin Oncol· October 2025

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FDA Approval Summary: Capecitabine Labeling Update under Project Renewal.
Sundeep Agrawal, Clara Lee, William F Pierce, Elizabeth Everhart, Adriene King-Ducre, Tamy Kim

Clin Cancer Res· December 2024

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Advancing Therapies for Asian Americans, Native Hawaiians, and Other Pacific Islanders With Cancer: OCE's Project ASIATICA.
Jennifer J Gao, Richard Pazdur, Tamy Kim

JCO Oncol Pract· September 2023

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Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021.
Sundeep Agrawal, Shaily Arora, Laleh Amiri-Kordestani, R Angelo de Claro, Lola Fashoyin-Aje, Tamy Kim

JAMA Oncol· February 2023

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Oncology Expanded Access and FDA's Project Facilitate.
Barbara Scepura, Mitchell Chan, Tamy Kim, Jessica Boehmer, Kirsten B Goldberg

Oncologist· October 2021

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U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program.
R Angelo de Claro, Jennifer J Gao, Tamy Kim, Paul G Kluetz, Marc R Theoret

Clin Cancer Res· January 2021

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Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016.
Jiaxi Zhou, Jonathon Vallejo, Paul Kluetz, Richard Pazdur, Tamy Kim

J Natl Cancer Inst· May 2019

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A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.
Julia A Beaver, Lynn J Howie, Lorraine Pelosof, Tamy Kim, Jinzhong Liu

JAMA Oncol· June 2018

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Regulatory watch: Evaluating the potential for digital submission of expedited premarket safety reports to the FDA.
Sean Khozin, Meredith Chuk, Tamy Kim, Geoffrey Kim, Richard Pazdur

Nat Rev Drug Discov· September 2016

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US Food and Drug Administration Efforts to Facilitate the Use of Expanded Access Programs.
Tamy Kim, Peter Lurie, Richard Pazdur

J Clin Oncol· November 2015

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Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials.
Marc R Theoret, Lee H Pai-Scherf, Meredith K Chuk, Tatiana M Prowell, Sanjeeve Balasubramaniam, Tamy Kim, Geoffrey Kim

Clin Cancer Res· October 2015

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Grassroots lobbying: an important tool for pharmacy. Lobbying begins in pharmacy school.
Tamy Kim

J Am Pharm Assoc (2003)· March 2004

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