Bioethicist Joins FDA to Help with Ped Trials

By Franklin, Deeanna | Clinical Psychiatry News, January 2004 | Go to article overview
Save to active project

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 designers at pharmaceutical companies.

The rest of this article is only available to active members of Questia

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
Loading One moment ...
Project items
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

Cited article

Bioethicist Joins FDA to Help with Ped Trials
Settings

Settings

Typeface
Text size Smaller Larger
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

While we understand printed pages are helpful to our users, this limitation is necessary to help protect our publishers' copyrighted material and prevent its unlawful distribution. We are sorry for any inconvenience.
Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

Cited passage

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

Thanks for trying Questia!

Please continue trying out our research tools, but please note, full functionality is available only to our active members.

Your work will be lost once you leave this Web page.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.

Are you sure you want to delete this highlight?