Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients
other · Food and Drug Administration · Rule · Published 1998-12-02 · 63 FR 66632
Document
Document number
98-31902
Federal Register citation
63 FR 66632
CFR reference
21 CFR 201
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-12-02
HHS docket
Docket No. 97N-0165
Abstract
The Food and Drug Administration (FDA) is issuing new regulations requiring pediatric studies of certain new and marketed drug and biological products. Most drugs and biologics have not been adequately tested in the pediatric subpopulation. As a result, product labeling frequently fails to provide directions for safe and effective use in pediatric patients. This rule will partially address the lack of pediatric use information by requiring that manufacturers of certain products provide sufficient data and information to support directions for pediatric use for the claimed indications.