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Results: 1-10 of 986

US bribery and corruption outlook
  • Hogan Lovells
  • USA
  • February 20 2017

Nations across the globe increasingly focus on preventing bribery and corruption and are coordinating their efforts to do so more than ever before


Trump Administration Issues Proposed Health Insurance Market Stabilization Rule: Will It Be Enough to Stabilize Exchange Participation and Premium Rates?
  • Hogan Lovells
  • USA
  • February 16 2017

On 15 February 2017, the Centers for Medicare & Medicaid Services (CMS) took a step toward addressing concerns about the stability of the individual


False Claims Act Alert: Fourth Circuit Punts on Sampling and Extrapolation
  • Hogan Lovells
  • USA
  • February 15 2017

Yesterday, the Fourth Circuit Court of Appeals ruled in the interlocutory appeal in United States ex rel. Michaels v. Agape Senior Community, Inc


2017 Legislative and Regulatory Outlook Contents
  • Hogan Lovells
  • USA
  • February 13 2017

President Donald Trump's victory in the election of 2016 had long coattails, helping Republicans narrowly maintain their majority in the Senate and


FDA: Implementation of Amended Intended Use Regulations Delayed Until March 21, 2017
  • Hogan Lovells
  • USA
  • February 8 2017

On February 7, 2017, the Food and Drug Administration (FDA) delayed implementation of its January 9, 2017, final rule addressing the regulation of


Ready, Set Cures Act Expanded Access Policy Deadline is Almost a Go
  • Hogan Lovells
  • USA
  • February 8 2017

As we have mentioned in a previous article, the 21st Century Cures Act (enacted December 13, 2016) gave companies 60 calendar days to make their


HHS overhauls the Common Rule to enhance protection for human subjects in research
  • Hogan Lovells
  • USA
  • February 6 2017

On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and


Just in Time: FDA Finalizes Guidance on Assessment of Abuse Potential of Drugs
  • Hogan Lovells
  • USA
  • January 25 2017

On January 17, 2017, just in time to evade the President’s Regulatory Freeze Memorandum, FDA announced the availability of a final guidance entitled


A “cure” for combination products: 21st Century Cures Act mandates greater transparency of combination product designations
  • Hogan Lovells
  • USA
  • January 25 2017

The 21st Century Cures Act, signed into law on December 13, 2016, ushers in significant, and interesting, changes to the regulatory review of


FDA Strengthens Requirements for Surgical Instrumentation Used with Urogynecologic Surgical Mesh
  • Hogan Lovells
  • USA
  • January 24 2017

Effective January 6, 2017, the U.S. Food and Drug Administration (FDA) reclassified surgical instrumentation for use with urogynecologic surgical