Search Results for Marks

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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

CBER Director Offers a Peek Into the Complexities of Where the Center is Headed By Zachary Brennan - Published 20 June 2017

In addition to protecting the US blood supply and ensuring vaccines are safe and effective, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is also now regulating complex gene and cell therapies, as well as a new category of treatments: regenerative medicines.

Categories: News, US, CBER, Biologics and biotechnology

Tags: CBER, CAR-T, hemophilia, Peter Marks