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Evaluating the potential for digital submission of expedited premarket safety reports to the FDA

Nature reviews. Drug discovery, 2016-09, Vol.15 (10), p.670-671

2016

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Project facilitate: Innovation and advancement in FDA’s oncology expanded access program

Journal of clinical oncology, 2022-06, Vol.40 (16_suppl), p.e18556-e18556

2022

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US Food and Drug Administration Efforts to Facilitate the Use of Expanded Access Programs

Journal of clinical oncology, 2015-11, Vol.33 (33), p.3979-3980

2015

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Oncology Expanded Access and FDA's Project Facilitate

The oncologist (Dayton, Ohio), 2021-10, Vol.26 (10), p.e1880-e1882

2021

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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

JAMA oncology, 2018-06, Vol.4 (6), p.849

2018

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Project facilitate: A review of the FDA oncology center of excellence expanded access pilot program

Journal of clinical oncology, 2020-05, Vol.38 (15_suppl), p.7023-7023

2020

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U.S. FDA analysis of enrollment of Asian patients from India in cancer clinical trials leading to approval from 2010 to 2022

Journal of clinical oncology, 2024-06, Vol.42 (16_suppl), p.e13779-e13779

2024

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Advancing Therapies for Asian Americans, Native Hawaiians, and Other Pacific Islanders With Cancer: OCE's Project ASIATICA

JCO oncology practice, 2023-09, Vol.19 (9), p.OP2300198-705

2023

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Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016

JNCI : Journal of the National Cancer Institute, 2019-05, Vol.111 (5), p.449-458

2019

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TRLS-01. FDA ANALYSIS OF EXPANDED ACCESS USE IN PEDIATRIC PATIENTS WITH CNS TUMORS FROM 2015 TO 2020

Neuro-oncology (Charlottesville, Va.), 2023-06, Vol.25 (Supplement_1), p.i78-i79

2023

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U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program

Clinical cancer research, 2021-01, Vol.27 (1), p.11-14

2021

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FDA Approval Summary: Capecitabine Labeling Update under Project Renewal

Clinical cancer research, 2024-10

2024

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Regulatory watch: Evaluating the potential for digital submission of expedited premarket safety reports to the FDA

Nature reviews. Drug discovery, 2016-10, Vol.15 (10), p.670-671

2016

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Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021

JAMA oncology, 2023-02, Vol.9 (2), p.266

2023

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FDA’s Oncology Center for Excellence Pilots Project Orbis: A framework for concurrent submission and review of oncology products among international partners

Journal of clinical oncology, 2020-05, Vol.38 (15_suppl), p.e14125-e14125

2020

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Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials

Clinical cancer research, 2015-10, Vol.21 (20), p.4545-4551

2015

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Food and Drug Administration analysis of 1332 single patient and emergency use expanded access (compassionate use) requests for patients with cancer over a duration of three years (2012-2014)

Journal of clinical oncology, 2016-05, Vol.34 (15_suppl), p.6523-6523

2016

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FDA breakthrough therapy designation of oncology products: The first-year experience

Journal of clinical oncology, 2014-05, Vol.32 (15_suppl), p.e17502-e17502

2014

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

Journal of the American Pharmacists Association, 2004-01, Vol.44 (1), p.8-9

Kim, Tamy

2004

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Grassroots Lobbying: An Important Tool for Pharmacy

Journal of the American Pharmacists Association, 2004-01, Vol.44 (1), p.5-9

Boyle, Cynthia J.

2004

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Discovering implicit entity relation with the gene-citation-gene network

PloS one, 2013-12, Vol.8 (12), p.e84639-e84639

2013

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Productivity and influence in bioinformatics: A bibliometric analysis using PubMed central

Journal of the American Society for Information Science and Technology, 2014-02, Vol.65 (2), p.352-371

2014

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Correction: Discovering Implicit Entity Relation with the Gene-Citation-Gene Network

PloS one, 2014-01, Vol.9 (1)

2014

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RMIP: Displacement ray tracing via inversion and oblong bounding

SIGGRAPH Asia 2023 Conference Papers, 2023, p.1-11

2023

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Altered neuronal nitric oxide synthase expression in the cerebellum of calcium channel mutant mice

Brain research, 2003-07, Vol.977 (2), p.129-140

2003

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Evaluating the potential for digital submission of expedited premarket safety reports to the FDA

Project facilitate: Innovation and advancement in FDA’s oncology expanded access program

US Food and Drug Administration Efforts to Facilitate the Use of Expanded Access Programs

Oncology Expanded Access and FDA's Project Facilitate

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review

Project facilitate: A review of the FDA oncology center of excellence expanded access pilot program

U.S. FDA analysis of enrollment of Asian patients from India in cancer clinical trials leading to approval from 2010 to 2022

Advancing Therapies for Asian Americans, Native Hawaiians, and Other Pacific Islanders With Cancer: OCE's Project ASIATICA

Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016

TRLS-01. FDA ANALYSIS OF EXPANDED ACCESS USE IN PEDIATRIC PATIENTS WITH CNS TUMORS FROM 2015 TO 2020

U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program

FDA Approval Summary: Capecitabine Labeling Update under Project Renewal

Regulatory watch: Evaluating the potential for digital submission of expedited premarket safety reports to the FDA

Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021

FDA’s Oncology Center for Excellence Pilots Project Orbis: A framework for concurrent submission and review of oncology products among international partners

Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials

Food and Drug Administration analysis of 1332 single patient and emergency use expanded access (compassionate use) requests for patients with cancer over a duration of three years (2012-2014)

FDA breakthrough therapy designation of oncology products: The first-year experience

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

Grassroots Lobbying: An Important Tool for Pharmacy

Discovering implicit entity relation with the gene-citation-gene network

Productivity and influence in bioinformatics: A bibliometric analysis using PubMed central

Correction: Discovering Implicit Entity Relation with the Gene-Citation-Gene Network

RMIP: Displacement ray tracing via inversion and oblong bounding

Altered neuronal nitric oxide synthase expression in the cerebellum of calcium channel mutant mice

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