Pediatric Bills' Generic Approval "Carve-Out" Needs Refinement, Hatch Says
Executive Summary
Provisions of bills to renew the pediatric exclusivity program which allow for approval of generics despite protected labeling by innovators should be revised, Sen. Orrin Hatch (R-Utah) said.
You may also be interested in...
Glucophage Provision Likely To Remain In Final Pediatric Exclusivity Bill
The Glucophage provision is likely to be included in the final version of pediatric exclusivity reauthorization legislation with no substantive changes
Glucophage Provision Likely To Remain In Final Pediatric Exclusivity Bill
The Glucophage provision is likely to be included in the final version of pediatric exclusivity reauthorization legislation with no substantive changes
Glucophage Exclusivity Compromise Could Resolve Pediatric Bill Delay
Democratic House Energy/Commerce Committee staff are considering a provision to assure a defined period of Glucophage exclusivity as a way out of the tie-up on pediatric exclusivity reauthorization legislation