Bioethicist Joins FDA to Help with Ped Trials
Franklin, Deeanna, Clinical Psychiatry News
Bioethicist Sara Goldkind has joined the Food and Drug Administration's Office of Pediatric Therapeutics in the Office of the Commissioner.
In 2001, when Congress reauthorized the statutory incentives for pediatric clinical trials, it mandated that the FDA establish the Office of Pediatric Therapeutics and include a bioethicist on staff.
The American Academy of Pediatrics drafted ethical guidelines for the study of drugs in pediatric patients, and several of the academy's recommendations were incorporated into the FDA's regulations. As part of her charter, Dr. Goldkind "will work with those regulations that relate to studies that are done with greater than minimal risk for generalizable information rather than for direct patient information or direct patient benefit."
She also will sit on several established FDA ethics panels, including a neonatal ethics working group and a pediatrics working group. Dr. Goldkind will work with the FDA's Office of Human Research Protections. Health and Human Services, and the National Institutes of Health, and play a consultative role with clinical trial …
Questia, a part of Gale, Cengage Learning. www.questia.com
Publication information: Article title: Bioethicist Joins FDA to Help with Ped Trials. Contributors: Franklin, Deeanna - Author. Magazine title: Clinical Psychiatry News. Volume: 32. Issue: 1 Publication date: January 2004. Page number: 78. © 2009 International Medical News Group. COPYRIGHT 2004 Gale Group.
This material is protected by copyright and, with the exception of fair use, may not be further copied, distributed or transmitted in any form or by any means.