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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House Oversight Committee Ranking Member Jim Jordan suggests that Congress may need to re-evaluate the length of pharma patents and FDA exclusivities.
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.