AAP News Vol. 15 No. 1 January 1999, p. 1
© 1999 American Academy of Pediatrics
This Article
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow E-mail this article to a friend
Right arrow Similar articles in this journal
Right arrow Alert me to new issues of the journal
Right arrow Add to My File Cabinet
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Llewellyn, S. T.
Right arrow Search for Related Content

Next Article 

FDA sets final rules for pediatric drugs

Sherry Trust Llewellyn

After more than a year of discussion, debate and considerable urging by the Academy, the Food and Drug Administration (FDA) released new rules Nov. 27 to provide health care practitioners with pediatric labeling information for drugs frequently used for infants and children. The new regulations require pharmaceutical companies to study the safety and effectiveness of new drugs and biologics that are important for children.

The Academy played a leadership role in working with the federal government to help develop these regulations, which will improve pediatric drug labeling. For months, the Academy urged the FDA to release these landmark rules, noting in official comments that they must take a "bold and long overdue step in advancing the health of our nation's infants, children and adolescents through the proposed regulations."