OCE Insights
How to Get the Dose Right
Mirat Shah, MD, Atiqur Rahman, PhD, Marc R. Theoret, MD, and Richard Pazdur, MD
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...
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
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...
Project Catalyst: Educating Industry to Help Develop Successful Cancer Therapies
Jeff Summers, MD, and Marc R. Theoret, MD
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
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...
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
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
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...
Update on Project Facilitate at the Oncology Center of Excellence
Mitchell Chan, PharmD, BCPS; Tamy Kim, PharmD; Jessica Boehmer, MBA; and Richard Pazdur, MD
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
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 ...
Patient-Centered Initiatives at the FDA
The ASCO Post Staff
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...
