Lilly CEO Breaks From PhRMA, Innovators With Support For CREATES Act
Executive Summary
Legislation that would prevent REMS from blocking generics appears to be gaining momentum.
You may also be interested in...
CREATES Act To Face Major Reshaping By Innovator-Friendly Amendments On Senate Floor
The Creating and Restoring Equal Access to Equivalent Samples Act clears US Senate Judiciary Committee. During markup, Sens. Hatch, R-Utah, and Cornyn, R-Tex., preview future amendments that would benefit innovators.
Shared REMS: US FDA Wants Brisk Brand-Generic Talks, Might Give Unilateral Waivers
New draft guidances are an attempt to curb abuse of REMS single shared system process to delay generic entry.
REMS Abuse Website: Celgene, Actelion Top List Of Suspected 'Gamers'
Other sponsors could be using tactics other than REMS abuse to game the system, US FDA Commissioner Scott Gottlieb says.