Search Results - "Kim, Tamy"

Evaluating the potential for digital submission of expedited premarket safety reports to the FDA by Khozin, Sean, Chuk, Meredith, Kim, Tamy, De, Suranjan, Sahoo, Sanjay, Kim, Geoffrey, Pazdur, Richard

Get full text

Project facilitate: Innovation and advancement in FDA’s oncology expanded access program by Chan, Mitchell, Antony, Ramya, Boehmer, Jessica, Kim, Tamy, Pazdur, Richard

“…e18556 Background: FDA Oncology Center of Excellence’s (OCE) Project Facilitate (PF) was launched in June 2019 in response to perceived barriers providers face…”
Get full text

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

Get full text

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

“…The Oncology Center of Excellence at the U.S. Food and Drug Administration launched Project Facilitate on May 31, 2019, to assist oncology health care…”
Get full text

Project facilitate: A review of the FDA oncology center of excellence expanded access pilot program by Kormanik, Natasha L, Chan, Mitchell, Boehmer, Jessica, Kim, Tamy, Blumenthal, Gideon Michael, Pazdur, Richard

“…Abstract only 7023 Background: Expanded Access (EA), also known as “compassionate use,” is a regulatory pathway in which a patient with an immediate…”
Get full text

U.S. FDA analysis of enrollment of Asian patients from India in cancer clinical trials leading to approval from 2010 to 2022 by Srivastava, Geetika, Leong, Ruby, Nair, Abhilasha, Kanapuru, Bindu, Rizvi, Fatima, Yang, Felice, Lee, Jennifer J., Wedam, Suparna B., Dilawari, Asma Ali, Fan, Chaohong, Lee, Sso, Andrada, Frances, Lee, Clara, Rivera, Donna, Lemery, Steven, Gao, Jennifer, Kim, Tamy, Pazdur, Richard

“…e13779 Background: There are an estimated 4.4 million Indian Americans (Asian Indian), constituting 1.35% of the United States (US) population. Indian…”
Get full text

Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016 by Zhou, Jiaxi, Vallejo, Jonathon, Kluetz, Paul, Pazdur, Richard, Kim, Tamy, Keegan, Patricia, Farrell, Ann, Beaver, Julia A, Sridhara, Rajeshwari

“…Abstract Background We previously conducted an overview of oncology products reviewed by the Office of Oncology Drug Products in the Center for Drug Evaluation…”
Get full text

TRLS-01. FDA ANALYSIS OF EXPANDED ACCESS USE IN PEDIATRIC PATIENTS WITH CNS TUMORS FROM 2015 TO 2020 by Duke, Elizabeth, Kormanik, Natasha, Barone, Amy, Chan, Mitchell, Antony, Ramya, Drezner, Nicole, Kluetz, Paul, Kim, Tamy, Singh, Harpreet, Pazdur, Richard, Donoghue, Martha

“…Few therapies are approved for children with central nervous system (CNS) tumors, and their prognosis is often poor. Expanded Access (EA) is a regulatory…”
Get full text

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

“…The FDA Oncology Center of Excellence commenced the Real-Time Oncology Review (RTOR) pilot project in February 2018 to facilitate earlier submission of topline…”
Get full text

FDA Approval Summary: Capecitabine Labeling Update under Project Renewal by Agrawal, Sundeep, Lee, Clara, Pierce, William F, Everhart, Elizabeth, King-Ducre, Adriene, Royce, Melanie, Osgood, Christy L, Amiri-Kordestani, Laleh, Chiu, Haw-Jyh, Ricks, Tiffany K, Pan, Lili, Fourie Zirkelbach, Jeanne, Charlab, Rosane, Pacanowski, Michael, Kim, Tamy, Pazdur, Richard, Kluetz, Paul G, Gao, Jennifer J

“…On December 14, 2022, the U.S. Food and Drug Administration (FDA) approved revisions to the United States Prescribing Information (USPI) for capecitabine that…”
Get full text

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

Get full text

Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021 by Agrawal, Sundeep, Arora, Shaily, Amiri-Kordestani, Laleh, de Claro, R Angelo, Fashoyin-Aje, Lola, Gormley, Nicole, Kim, Tamy, Lemery, Steven, Mehta, Gautam U, Scott, Emma C, Singh, Harpreet, Tang, Shenghui, Theoret, Marc R, Pazdur, Richard, Kluetz, Paul G, Beaver, Julia A

“…Single-arm trials have allowed for transformative therapies to be made available to patients expeditiously. However, using single-arm trials to support drug…”
Get more information

FDA’s Oncology Center for Excellence Pilots Project Orbis: A framework for concurrent submission and review of oncology products among international partners by Spillman, Dianne, Arora, Shaily, Venugopal, Rajesh, Scott, Bradley, Golding, Sarah, Richardson, Nicholas, Kasamon, Yvette L., Ethier, Jean-Francois, Gurd, Kate, Singh, Harpreet, DeClaro, R. Angelo, Beaver, Julia A., Kim, Tamy, Goldberg, Kirsten B., Kluetz, Paul Gustav, Theoret, Marc Robert, Pazdur, Richard

“…Abstract only e14125 Background: Cancer therapeutics often receive FDA approval months to years before regulatory submission to other countries. [i]…”
Get full text

Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials by Theoret, Marc R, Pai-Scherf, Lee H, Chuk, Meredith K, Prowell, Tatiana M, Balasubramaniam, Sanjeeve, Kim, Tamy, Kim, Geoffrey, Kluetz, Paul G, Keegan, Patricia, Pazdur, Richard

“…In 1962, the passage of the Kefauver-Harris Amendment to the 1938 Food, Drug, and Cosmetic Act required that sponsors seeking approval of new drugs demonstrate…”
Get full text

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) by Lemery, Steven J., Mailankody, Sham, Kazandjian, Dickran, Smit, Marie-Anne Damiette, Blumenthal, Gideon Michael, Kim, Tamy, Keegan, Patricia, Pazdur, Richard

“…Abstract only…”
Get full text

FDA breakthrough therapy designation of oncology products: The first-year experience by Ning, Yangmin M., Kim, Tamy, Maher, Virginia Ellen, Ibrahim, Amna, Murgo, Anthony J., Farrell, Ann T., Keegan, Patricia, Justice, Robert L., Pazdur, Richard

“…Abstract only…”
Get full text

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

Get full text

Grassroots Lobbying: An Important Tool for Pharmacy by Boyle, Cynthia J.

Get full text