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Setting a rogue to catch a rogue: the changing face of Lincoln's Law
  • Hogan Lovells
  • USA
  • August 25 2016

The False Claims Act is big business for the US government. Since January 2009, the government has recovered more than $30 billion through


Setting a rogue to catch a rogue: the changing face of Lincoln's Law
  • Hogan Lovells
  • USA
  • August 22 2016

The False Claims Act is big business for the US government. Since January 2009, the government has recovered more than $30 billion through False


FPF Releases Guide for Consumer Wearables and Wellness Apps and Devices
  • Hogan Lovells
  • USA
  • August 18 2016

On Wednesday, August 17, 2016, the Future of Privacy Forum (FPF) released a set of detailed guidelines for the collection and use of


340B Program: HRSA Issues Dispute Resolution Proposed Rule
  • Hogan Lovells
  • USA
  • August 15 2016

On August 11, 2016, the Health Resources and Services Administration (HRSA) released a Notice of Proposed Rulemaking (NPRM) defining a proposed


DEA Keeps Marijuana in Schedule I While Expanding Access for Research and Clarifying Rules on Hemp
  • Hogan Lovells
  • USA
  • August 12 2016

Yesterday, the U.S. Drug Enforcement Administration (DEA) took a number of actions regarding the federal control of marijuana, including denying a


“Institutional Review Board (IRB) Written Procedures” Draft Guidance and NIH’s “Single IRB Policy” Offer Food for Thought to IRBs Charged with Oversight of Human Subjects Research
  • Hogan Lovells
  • USA
  • August 8 2016

Last week, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) of the U.S. Department of Health and


MHRA Publishes Draft Guidance on GxP Data Integrity
  • Hogan Lovells
  • USA
  • August 8 2016

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published for public consultation a draft guidance on GxP Data Integrity which


FDA Issues Final General Wellness Product Guidance
  • Hogan Lovells
  • USA
  • August 4 2016

On July 29, 2016, the Food and Drug Administration (FDA or the Agency) released its final guidance document entitled, General Wellness: Policy for


Commerce Department and State Department Change Rules related to Toxicological Agents, Medical Countermeasures, Protective Gear, Coatings and Related Items and Technology as well as Directed Energy Weapons
  • Hogan Lovells
  • USA
  • August 4 2016

On July 28, 2016, the Commerce Department and the State Department issued new final rules effective December 31, 2016 regarding certain plant and


OCR Emphasizes Security Obligations of Business Associates with Latest Enforcement
  • Hogan Lovells
  • USA
  • August 3 2016

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is taking an aggressive stand on HIPAA enforcement and targeting