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New Chemical Entity (NCE)

A drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. An NCE is a molecule developed by the innovator company in the early drug discovery stage, which after undergoing clinical trials could translate into a drug that could be a cure for some disease. Synthesis of an NCE is the first step in the process of drug development.
US FDA will convene one-day public workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations
The US Food and Drug Administration (US FDA) will hold a one-day Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations on November 2, 2010 to facilitate an exchange of information about best practices in conducting cell and gene therapy clinical trials in pediatric populations.

The purpose of the workshop is to gather information from Institutional Review Boards (IRBs), gene and cellular therapy clinical researchers, and other stakeholders regarding best practices related to cell and gene therapy clinical trials in pediatric populations, as well as challenges and considerations in the review of these clinical trials.

The workshop will include presentations on cell and gene therapy clinical trials in pediatric populations.  The workshop will include panel discussions  regarding best practices related to cell and gene therapy clinical trials in pediatric populations including those related to: (1) evaluating these novel therapeutic products prior to initiating pediatric clinical studies; (2) identifying and minimizing risks associated with the administration of cell and gene therapy products in pediatric populations; (3) obtaining informed consent and assent; and (4)  conducting continuing review, of cell and gene therapy products in pediatric populations.  The workshop also will include panel discussions addressing the challenges and considerations in the review of cell and gene therapy clinical trials in pediatric populations and the role of institutional review boards.

Date
November 2, 2010
8:00 AM-5:30 PM

Workshop Location
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Rd
North Bethesda, MD 20852

Registration
There is no registration fee for the public workshop.