Pediatric Exclusivity Could Be Out-Licensed To Other Sponsors, FDA Suggests
This article was originally published in The Tan Sheet
Executive Summary
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.
You may also be interested in...
Pediatric Study Royalty Fund Would Be Created By Wellstone Amendment
Drug companies would be required to set aside a portion of product sales to fund pediatric research for off-patent drugs under an amendment Sen. Paul Wellstone (D-Minn.) will offer to the pediatric exclusivity reauthorization bill when it is considered on the Senate floor.
Pediatric Study Royalty Fund Would Be Created By Wellstone Amendment
Drug companies would be required to set aside a portion of product sales to fund pediatric research for off-patent drugs under an amendment Sen. Paul Wellstone (D-Minn.) will offer to the pediatric exclusivity reauthorization bill when it is considered on the Senate floor.
Pediatric Study Royalty Fund Would Be Created By Wellstone Amendment
Drug companies would be required to set aside a portion of product sales to fund pediatric research for off-patent drugs under an amendment Sen. Paul Wellstone (D-Minn.) will offer to the pediatric exclusivity reauthorization bill when it is considered on the Senate floor.