The Competent Authorities for Medical Devices (“CAMD”) has published a roadmap concerning the implementation of the Medical Devices Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”). The roadmap has been prepared in cooperation with the European Commission and it is intended to address the challenges of the MDR and IVDR implementation. View Full Post
After years of investigation and litigation, and on the eve of a highly anticipated trial, the government abandoned its FCA case against ManorCare, the nation’s second-largest operator of skilled nursing homes and assisted living centers.  In a joint motion filed on November 8, 2017, the government announced that it would move for dismissal with prejudice of U.S. View Full Post
On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited programs available for the development and review of certain regenerative medicine therapies.  Importantly, the draft guidance clarifies important aspects of the Regenerative Medicine Advanced Therapy (RMAT) designation established by the 21st Century Cures Act.  View Full Post
Post at a glance: FinCEN imposes $8 million penalty against California’s biggest and oldest card club Club failed to implement and maintain an effective anti-money laundering (AML) program and failed to detect, deter, and report suspicious transactions Enforcement action serves as valuable reminder of scope of Bank Secrecy Act (BSA) As mentioned in our prior AML Update, the U.S. View Full Post
The Department of Defense (“DoD”) has issued two Class Deviations that provide defense agencies with greater flexibility when procuring in times of crisis. These Class Deviations allow for the use of simplified acquisition procedures and excuse certain procurement obligations when DoD is responding to a cyber-attack or providing relief in support of domestic or international disasters. View Full Post