 |
|
New Rule Requires Labeling Information for Pediatric Use
JAMA. 1999;281:27.
|
|
| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
|
|
|
The FDA has issued a final regulation requiring that applications from pharmaceutical companies for new drugs and biological products contain sufficient data and information to support directions for pediatric use for the claimed indications if they (1) provide a meaningful therapeutic benefit to children or (2) are likely to be used in a substantial number of pediatric patients. The required study can be deferred until after approval if, for example, FDA finds that it is appropriate to delay pediatric studies until sufficient data are collected in adults or if imposition of the requirement would delay the availability of a new drug for adults. The requirement can also be waived if FDA finds that the product is likely to be unsafe or ineffective in pediatric patients, that pediatric studies are impossible or highly impractical, or that reasonable efforts to develop a pediatric formulation have failed.
The scope of the final rule . . . [Full Text of this Article]
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Establishment of a Clinical Trials Office at a Children's Hospital
Abzug and Esterl
Pediatrics 2001;108:1129-1134.
ABSTRACT
| FULL TEXT
|
