Tag Archives: Regulatory

Does the Agency Need Statutorily Imposed Incentives for Regulatory Compliance Matters?

By Mark I. Schwartz — Last year, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA) to revise and extend the user fee programs for drugs, medical devices and biosimilar biological products. Section 902 of FDARA … Continue reading

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CMS Uses Regulatory Levers to Chip Away at Affordable Care Act Protections

On Monday, the Centers for Medicare and Medicaid Services (“CMS”) released (1) the Notice of Benefit and Payment Parameters for 2019 final rule (“Final Rule”), (2) the Final Annual Issuer Letter and (3) guidance on hardship exemptions and transitional policies. … Continue reading

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Federal Regulatory Agencies Advise on Cyber Insurance for Information Security Programs

Federal regulatory agencies, acting through the Federal Financial Institutions Examination Council (FFIEC), have issued guidance for financial institutions about the role of cyber insurance in risk management of information technology systems. See, e.g., FDIC FIL-16-2018 (April 10, 2018); OCC Bulletin 2018-8 (April 11, 2018). The … Continue reading

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IOSCO recommendations to improve regulatory reporting and transparency in corporate bond markets

On 5 April 2018, the International Organisation of Securities Commissions (IOSCO) published a final report containing recommendations for improving the information on secondary corporate bond markets available to both regulators and the public. The final report recommends that regulatory authorities … Continue reading

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Regulatory reform signals potential spike in M&A activity involving US financial institutions

On March 14, 2018, the US Senate voted (67-31) to advance S. 2155, the Economic Growth, Regulatory Relief, and Consumer Protection Act (the Bill). The Bill, which will only become law with approval from the House and Congress, marks an unprecedented, bipartisan compromise … Continue reading

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