Posts tagged Benjamin Tso.
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4 minute read
On October 24, 2016 the Food and Drug Administration ("FDA") in conjunction with the Centers for Medicare & Medicaid Services ("CMS") announced their intention to extend the Parallel Review pilot program indefinitely. The Parallel Review process is intended to provide timely feedback on clinical data requirements from FDA and CMS, and minimize the time required for receiving Medicare coverage nationally. Sounds good. So, why have so few manufacturers taken advantage of the program to date?
Despite its admirable goals, the current Parallel Review Process is too limited in scope ...
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Recent Updates
- EDPA Ramps Up Its White-Collar Enforcement Framework
- California Governor Signs AB 1415 Compromise Legislation Regulating Private Equity and Hedge Fund Activity
- DOJ’s Final Rule on Bulk Data Transfers: The First 180 Days
- California Governor Signs SB 351, Strengthening the State’s Corporate Practice of Medicine Doctrine
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