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Results:1-10 of 40

Free speech & pharmaceutical promotion U.S. ex rel. Solis v. Millennium Pharmaceuticals, Inc.
  • King & Spalding LLP
  • USA
  • February 23 2015

Off-label prescription drug use using drugs to treat ailments not indicated on FDA-approved labeling is among the thorniest legal


CMS clarifies guidance on single dosesingle use medications to prevent infection
  • King & Spalding LLP
  • USA
  • July 2 2012

On June 15, 2012, the Office of Clinical Standards and QualitySurvey & Certification Group at CMS issued a memorandum regarding the CMS regulatory and policy requirements for repackaging single-dose vials or single-use vials (SDVs) of drug products into smaller dose quantities.


OIG publishes Fiscal Year 2012 work plan
  • King & Spalding LLP
  • USA
  • October 11 2011

Last week, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published its work plan for the 2012 fiscal year in which it described its primary objectives for the year.


Trans-Pacific Partnership moves forward at Chicago meeting
  • King & Spalding LLP
  • USA, Malaysia, New Zealand, Peru, Australia, Singapore, Vietnam, Brunei, Chile
  • October 1 2011

The eighth round of negotiations for the Trans-Pacific Partnership (“TPP”) took place during September 6-15 in Chicago, IL.


FDA lacks authority to enjoin traditional animal drug compounding
  • King & Spalding LLP
  • USA
  • September 19 2011

On September 12, 2011, the United States District Court for the Middle District of Florida entered an order denying the U.S. Food and Drug Administration’s request for an injunction barring Franck’s Lab, a Floridabased pharmacy, from engaging in traditional, state-licensed bulk compounding of animal drugs and granting Franck’s motion for summary judgment.


House Democrats outline potential healthcare cuts for supercommittee
  • King & Spalding LLP
  • USA
  • September 12 2011

On September 7, 2011, Democrats on the House Ways and Means Committee put forth a 13-page outline of potential cuts in healthcare spending for consideration by the deficit-cutting congressional “supercommittee,” charged with proposing a $1.2 trillion savings plan.


HHS final rule regarding investigator financial interests
  • King & Spalding LLP
  • USA
  • September 7 2011

The Department of Health and Human Services (HHS) issued a Final Rule on August 25 that amends the 1995 regulations “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (42 C.F.R. Part 50, Subpart F) and “Responsible Prospective Contractors” (45 C.F.R. Part 94).


CMS holds external stakeholders meeting regarding the development of national average drug acquisition cost
  • King & Spalding LLP
  • USA
  • August 8 2011

On Thursday, August 4, 2011, the Centers for Medicare and Medicaid Services (CMS) held a Stakeholders Meeting on the development of its new pricing metric, the “national average drug acquisition cost” or “NADAC.”


European Commission finds “pay for delay” deals on the decline in Europe but pharma sector antitrust scrutiny continues
  • King & Spalding LLP
  • European Union
  • July 12 2011

On July 6, 2011 the European Commission (Commission) published the results of its second monitoring exercise of patent settlements in the pharmaceutical sector (Second Monitoring Report).


CMS takes steps to implement actual acquisition cost
  • King & Spalding LLP
  • USA
  • July 11 2011

On Friday, July 8, 2011, the Centers for Medicare and Medicaid Services (CMS) released a long-awaited announcement that it had selected a contractor to conduct monthly surveys of retail pharmaceutical prices and payments.