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Health Law Update - December 15, 2016
  • Baker & Hostetler LLP
  • USA
  • December 15 2016

Welcome to this week's edition of the Health Law Update. In this Issue: 21st Century Cures: Not Just a Biomed Bill 21st Century Cures: Ambitious


Vermont to Require Drug Transparency
  • Baker & Hostetler LLP
  • USA
  • June 16 2016

Vermont recently became the first state to require drug manufacturers to provide justification for price increases. Under the new law, data on the


New Medicare Part B Payment Model is Most Recent Payor Response to Increasing Drug Prices
  • Baker & Hostetler LLP
  • USA
  • April 7 2016

Recent activity by the federal government along with commercial payors may be indicative of further changes to how payors, providers, and


CMS Pitches Controversial Payment Model for Medicare Part B Drugs
  • Baker & Hostetler LLP
  • USA
  • March 24 2016

CMS recently announced a proposed rule that would potentially create a new Medicare Part B prescription drug payment model. The proposed model is


Five Types of Exclusivities
  • Baker & Hostetler LLP
  • USA
  • February 8 2016

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of


Don’t flush the drugs! The EPA is coming!
  • Baker & Hostetler LLP
  • USA
  • September 24 2015

The Environmental Protection Agency (EPA) recently issued a pre-publication Proposed Rule (40 C.F.R. part 266, subpart P) regulating the management


FDA committee to continue considering drug compounding issues
  • Baker & Hostetler LLP
  • USA
  • June 2 2015

The advisory committee tasked with providing advice on medical, scientific and technical issues to the Food and Drug Administration (FDA) on


FDA addresses compounding of animal drugs from bulk drug substances
  • Baker & Hostetler LLP
  • USA
  • May 21 2015

The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice


Amarin Pharma sues FDA over constitutional right to discuss off-label uses
  • Baker & Hostetler LLP
  • USA
  • May 14 2015

Drug makers and the Food and Drug Administration (FDA) have often disagreed over whether drug makers can discuss unapproved uses for their products


FDA establishes docket for public comments on drug compounding
  • Baker & Hostetler LLP
  • USA
  • March 12 2015

The Food and Drug Administration (FDA) recently announced a new docket for public comments on the compounding of human drug products under sections