Advertisement

Advertisement

OCE Insights

Issues in Oncology

How to Get the Dose Right

Mirat Shah, MD, Atiqur Rahman, PhD, Marc R. Theoret, MD, and Richard Pazdur, MD  /  May 10, 2022

OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Mirat Shah, MD, of the Office of Oncologic Diseases, Center for Drug Evaluation and Research, FDA; Atiqur Rahman...

Issues in Oncology

Project Confirm: An Initiative to Promote Transparency of the Accelerated Approval Program for Oncology Indications

Gautam U. Mehta, MD; Fatima Rizvi, PharmD; and Tamy Kim, PharmD  /  March 10, 2022

OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Gautam U. Mehta, MD, Neurosurgical Oncologist and Clinical Reviewer, Division of Oncology 2; Fatima Rizvi, Pharm...

Issues in Oncology

Project Catalyst: Educating Industry to Help Develop Successful Cancer Therapies

Jeff Summers, MD, and Marc R. Theoret, MD  /  January 25, 2022

OCE Insights is written by members of the Oncology Center of Excellence (OCE) and the Office of Oncology Diseases (OOD) at the U.S. Food and Drug Administration. In this installment, Jeff Summers, MD, OOD Acting Associate Director for Translational Sciences, and Marc R. Theoret, MD, OCE Deputy Direc...

The Oncology Center of Excellence Encourages Submissions of Applied Regulatory Science Research Proposals

Julie A. Schneider, PhD; Jennifer J. Gao, MD; Donna R. Rivera, PharmD, MS; Martha B. Donoghue, MD; Gregory H. Reaman, MD, FASCO, Associate Director for Pediatric Oncology, OCE; Rajeshwari Sridhara, PhD; Julia A. Beaver, MD; Paul G. Kluetz, MD; Marc R. Theoret, MD; and Richard Pazdur, MD  /  December 25, 2021

OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Julie A. Schneider, PhD, Associate Director for Research Strategy and Partnerships, OCE; Jennifer J. Gao, MD, As...

Issues in Oncology

Project Orbis: Partnering With International Regulatory Agencies to Bring Earlier Global Access to Novel Cancer Treatments

Preeti Narayan, MD; Dianne Spillman, BS; Lauren Hotaki, PharmD, BCPS, BCIDP; R. Angelo De Claro, MD; Richard Pazdur, MD  /  December 10, 2020

OCE Insights is an occasional department developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Preeti Narayan, MD, a medical oncologist and clinical reviewer on the Breast and Gynecologic Disease Team, D...

This Year’s FDA-ASCO Workshop Focused on Collection of Patient-Reported Tolerability Data From Clinical Trials

Vishal Bhatnagar, MD; Bellinda King-Kallimanis, PhD; Paul Kluetz, MD; Heidi Klepin, MD; and Kathryn Mileham, MD  /  November 25, 2020

OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Vishal Bhatnagar, MD, Associate Director for Patient Outcomes, Bellinda King-Kallimanis, PhD, Senior Staff Fello...

Issues in Oncology

Update on Project Facilitate at the Oncology Center of Excellence

Mitchell Chan, PharmD, BCPS; Tamy Kim, PharmD; Jessica Boehmer, MBA; and Richard Pazdur, MD  /  February 25, 2020

OCE Insights is an occasional department developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Mitchell Chan, PharmD, BCPS, Regulatory Project Manager; Tamy Kim, PharmD, Associate Director of Regulatory ...

Project Socrates: An Educational Bridge From the FDA to the Public

Jennifer J. Gao, MD, and Richard Pazdur, MD  /  November 25, 2019

OCE Insights is an occasional department developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Jennifer J. Gao, MD, Acting Associate Director of Education in the OCE, and Richard Pazdur, MD, Director of ...

Issues in Oncology

Patient-Centered Initiatives at the FDA

The ASCO Post Staff  /  September 25, 2019

OCE Insights is a periodic column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this first installment, Vishal Bhatnagar, MD, Acting Associate Director of Patient Outcomes; Bellinda King-Kallimanis, PhD, Senior St...

Advertisement

Advertisement



Advertisement