Search Results for oncology center of excellence

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FDA's Woodcock, Marks and Pazdur Talk Sustainability and New Approaches By Zachary Brennan - Published 14 November 2017

Three of the US Food and Drug Administration's (FDA) top experts sat together on a panel at the third Biopharma Congress in Washington, D.C. on Tuesday, discussing everything from where the agency is headed in the next several years, how the costly clinical trial system is not sustainable and how they interview prospective FDA employees.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Drugs

Tags: Pazdur, Marks, Woodcock, oncology center of excellence

Advances in Sequencing Likely to Shift Paradigm in Cancer Drug Approvals, FDA Experts Say By Zachary Brennan - Published 07 November 2017

Experts within FDA's newly established Oncology Center of Excellence (OCE) discussed the office's role in the first site-agnostic cancer treatment approval and programs for further advancing oncology-related regulatory science and policy.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Regulatory intelligence, Regulatory strategy

Tags: DNA sequencing, Oncology Center of Excellence, biomarker, OS

FDA’s Pazdur and Blumenthal: The March of Checkpoint Inhibitors Will Continue By Zachary Brennan - Published 21 February 2017

More approvals of new immune-checkpoint inhibitors, targeted and personalized therapies, as well as the use of real-world evidence are coming in the near future, Richard Pazdur, director of the Office of Hematology and Oncology at the US Food and Drug Administration (FDA) and associate director Gideon Blumenthal wrote in a comment published this week in Nature.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Research and development

Tags: oncology, Pazdur, Oncology Center of Excellence, FDA cancer drug approvals

Pazdur to Head New Oncology Center at FDA By Michael Mezher - Published 29 June 2016

Vice President Joseph Biden on Wednesday named the US Food and Drug Administration's (FDA) top oncologist, Dr. Richard Pazdur, to head the newly formed Oncology Center of Excellence (OCE).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Submission and registration

Tags: Oncology Center of Excellence, OCE, Richard Pazdur