Search Results for CAR-T

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Nature Editorial: FDA Needs Help Assessing Cutting-Edge Tech Published 07 August 2017

The US Food and Drug Administration (FDA) is increasingly being tasked with evaluating cutting-edge therapies and technology that its in-house expertise may not be able to address, according to a Nature editorial, which recommends academic scientists help the agency.

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

Tags: CAR-T, academic scientists, Scott Gottlieb

FDA Panel Votes Unanimously in Favor of First CAR-T Cancer Therapy By Zachary Brennan - Published 12 July 2017

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee on Wednesday voted unanimously, 10 to 0, in favor of the benefit-risk profile for the first of a new kind of cancer therapy, known as a Chimeric Antigen Receptor T-cell (CAR-T) therapy.

Categories: News, US, FDA, Government affairs, Human cell and tissue, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: CAR-T, Novartis, CTL019, gene therapy, cell therapy, ODAC

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