Pediatric studies for off-patent cancer drugs
Executive Summary
The Pediatric Subcommittee of FDA's Oncologic Drugs Advisory Committee will consider the availability of safety and efficacy data on off-patent oncology drugs for the pediatric population and whether additional information is needed at an Oct. 9 meeting. Age-appropriate formulation changes to facilitate dosing of products used in the pediatric oncology setting will also be discussed. The meeting will be held at the Holiday Inn in Silver Spring, Md. beginning at 8 a.m...