Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Sentinel Initiative workshop set for Jan. 31. Trade group offers tips on communicating about phthalates in medical devices.
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Final FDA Bill: Device Provisions
Congress has settled on final language for the FDA Safety and Innovation Act. After Senate approval, the bill will go to the White House for President Obama’s signature.
Sandoz Stands Alone As It Completes Novartis Spinoff
Sandoz has heralded a “new era as a standalone global leader and European champion in generic and biosimilar medicines” after completing its long journey towards independence by separating from former parent company Novartis.
Cell/Gene Therapy Is Ripe For Real-World Data Given Length Of Follow-Up Required, Abernethy Says
The former principal deputy commissioner outlined what she sees as the future data requirements for real world evidence and why cell and gene therapy will lead the way.