Pediatric Labeling Negotiations Limited To Six Months In Reauthorization Bill
This article was originally published in The Tan Sheet
Executive Summary
Negotiations for pediatric labeling changes would be limited to six months under a proposed bill to reauthorize the pediatric exclusivity provisions.
You may also be interested in...
FDA Pediatric Therapeutics Office Could Fall Under ORM Purview
FDA's Office of Pediatric Therapeutics would be located within the Office of Review Management under proposed organizational changes at the agency.
PDUFA III Could Move Through Congress In 2001, Rep. Burr Suggests
FDA's post-approval surveillance system should be discussed as part of the reauthorization process for the Prescription Drug User Fee Act, Rep. Richard Burr (R-N.C.) said during a May 3 House Energy & Commerce Committee/Health Subcommittee hearing on implementation of the FDA Modernization Act.
Pediatric Exclusivity Could Be Out-Licensed To Other Sponsors, FDA Suggests
Congress should consider allowing pediatric exclusivity periods to be licensed to other sponsors as a mechanism for promoting pediatric study of drug products that do not have patent protection or exclusivity, FDA's pediatric exclusivity status report suggests.