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Antitrust regulators emphasize importance of innovation for merger control assessment - Commission considering revision of EU merger control thresholds
  • Hogan Lovells
  • USA
  • April 21 2016

Antitrust regulators around the globe reinforce the importance of innovation for the assessment of mergers and acquisitions. The European Commission


New VA Policy Regarding TAA Non-Compliant Covered Drugs
  • Hogan Lovells
  • USA
  • April 20 2016

The Department of Veterans Affairs (VA) recently announced a fundamental shift in policy that will now require manufacturers to list Veterans Health


Product Design and Safety Considerations
  • Hogan Lovells
  • USA
  • April 14 2016

The FDA issued its final guidance for the industry on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication


FDA Issues Data Integrity Guidance, Providing Views on Expected Data Integrity Controls and Oversight
  • Hogan Lovells
  • USA
  • April 14 2016

Earlier today, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance addressing a topic affecting the entire pharmaceutical


Drug pricing myths and realities
  • Hogan Lovells
  • USA
  • April 11 2016

Turing Pharmaceuticals CEO Martin Shkreli and his notorious $750 pill have brought new media attention and public outcry to the already contentious


FTC Releases Web Tool for Mobile Health App Developers
  • Hogan Lovells
  • USA
  • April 6 2016

The FTC released this week a web-based tool to assist mobile app developers in determining which federal privacy laws apply to their mobile health


OCR Releases Updated Audit Protocol
  • Hogan Lovells
  • USA
  • April 4 2016

The revamped audit protocol for the upcoming HIPAA Phase 2 audits has been released by the US Department of Health and Human Services Office for


Paving a New Road in FCA Cases: AseraCare Court Grants Summary Judgment for Hospice, Protecting Physician Judgment
  • Hogan Lovells
  • USA
  • April 1 2016

Blocking the government's road to recovery, the Northern District of Alabama granted summary judgment in favor of AseraCare Inc., a national hospice


OCR Highlights Priorities as it Steps Up HIPAA Enforcement
  • Hogan Lovells
  • USA
  • March 29 2016

Last week, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) launched the long-awaited Phase 2 HIPAA Audit Program


NIH and FDA Announce Release of Draft Clinical Trial Protocol Template; Call for Comments by April 17, 2016
  • Hogan Lovells
  • USA
  • March 28 2016

The National Institutes of Health (NIH) and Food and Drug Administration (FDA) announced on March 17, 2016, their co-development of a draft clinical