Lilly CEO Breaks From PhRMA, Innovators With Support For CREATES Act
Legislation that would prevent REMS from blocking generics appears to be gaining momentum.
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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.
New draft guidances are an attempt to curb abuse of REMS single shared system process to delay generic entry.
Other sponsors could be using tactics other than REMS abuse to game the system, US FDA Commissioner Scott Gottlieb says.