Search Results for Pazdur

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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

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

FDA Shares Views on Juvenile Animal Studies for Oncology Drugs By Michael Mezher - Published 25 March 2016

In a recently published article, officials from the US Food and Drug Administration (FDA) say that studies comparing the effects of drugs in juvenile animal populations against their effects in adult animals are generally not useful in guiding pediatric clinical development, especially if such studies delay the launch of a clinical trial.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Preclinical

Tags: Juvenile animal studies, pediatric trials, Richard Pazdur

FDA Approves Orphan Drug Application for Pfizer CML Drug By Alexander Gaffney - Published 05 September 2012

Categories: FDA

Tags: Pfizer, CML, Pazdur, OHOP, Latest News

Capping Busy Week, FDA Approves Breast Cancer, Multiple Myeloma Drugs By Alexander Gaffney - Published 23 July 2012

Categories: FDA

Tags: Ferring, Multiple Myeloma, Onyx, HER2, Breast Cancer, Pazdur, Latest News, approval, NME

FDA Approves New Breast Cancer Drug Despite Manufacturing Concerns By Alexander Gaffney - Published 11 June 2012

Categories: FDA, CDER

Tags: Perjeta, Herceptin, Breast Cancer, Woodcock, Pazdur, Latest News

FDA Anticipates Spike in Oncology Drugs, Reduction in Shortages By Alexander Gaffney - Published 05 June 2012

Categories: FDA

Tags: Accelerated Approvals, Conditional Approvals, Pazdur, Oncology, Latest News, Drug Shortages, cancer

New FDA Guidance Could See Patients Obtaining Quicker Access to Experimental Therapies By Alexander Gaffney - Published 04 June 2012

Categories: FDA

Tags: pCR, Breast Cancer, Surrogate Endpoint, Pazdur, Latest News, Hamburg, draft guidance, clinical trials

FDA Oncology Team Provides Insight into Review Process, Advisory Committees, Oncology Development By Alexander Gaffney - Published 07 February 2012

Categories: FDA, Drugs

Tags: Reviews, Pazdur, OHOP, Oncology, Latest News, cancer, review, regulatory