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Earlier today, FDA published guidance, for immediate implementation, effectively delaying the effective date of the product tracing requirements for manufacturers, wholesale distributors or repackagers until May 1, 2015. This guidance appears to be a continuation of FDA's efforts to address industry's concerns about the implementation of the DSCSA product tracing requirements that are effective January 1, 2015.
It is unclear whether the ghosts of FDA past, present or future had anything to do with today's announcement, but this Dickens-esque change of heart should ensure ...
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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
- No Remuneration Plus No "But-For" Causation (Between an Alleged Kickback and Claims Submitted to the Government) Means No FCA Violation, District Court Says