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Drug Costs Targeted in Administration’s Fiscal Year 2019 Budget
  • Cooley LLP
  • USA
  • February 13 2018

Yesterday, the Administration released its Fiscal Year 2019 (FY19) Budget blueprint. The $4.4 trillion Budget blueprint includes several proposals

FDA’s Proposed New Pathway for Devices Referencing Drugs (DRDs)
  • Hogan Lovells
  • USA
  • January 19 2018

The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable

California Passes Two Drug Pricing Transparency Laws
  • Quarles & Brady LLP
  • USA
  • November 20 2017

Last month, California Governor Jerry Brown signed two new bills aimed at curtailing rising prescription drug costs, joining other states like

FTC Holds Public Workshop to Consider If Hatch-Waxman Is Working for Prescription Drug Competition
  • Arent Fox LLP
  • USA
  • November 13 2017

On November 8, 2017, the Federal Trade Commission held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply

Anticipated Acts of Infringement May Establish Venue for Hatch-Waxman
  • McDermott Will & Emery
  • USA
  • October 31 2017

Addressing venue in the context of Hatch-Waxman litigation, the US District Court for the District of Delaware held that venue is proper in Delaware

The legal and regulatory challenges of getting a biosimilar product to market
  • CMS Cameron McKenna Nabarro Olswang LLP
  • USA, European Union
  • August 30 2017

The global biosimilars market is expected to reach $10.9 billion by 2021, according to the Biosimilars Global Forecast

Opportunity - FDA encouraging manufacture and distribution of new generic drugs
  • Innofy
  • USA
  • July 21 2017

The U.S. Food and Drug Administration (FDA) are desperately seeking to increase competition for prescription drugs. The reasons for this are of no

FDA Holds Public Meeting on Innovation in Drug Development and Accelerating Access to Generic Medicines
  • Arent Fox LLP
  • USA
  • July 20 2017

On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and Accelerating the access

FDA Issues Draft Guidance on Pre-Submission Facility Correspondence - A Way to Reduce FDA Action Times for Priority ANDAs
  • Duane Morris LLP
  • USA
  • July 14 2017

FDA has set a goal to review and act on priority ANDAs two months faster if the submission meets all PFC requirements. The U.S. Food and Drug

User Fee Reauthorization Picks Up Steam
  • Cooley LLP
  • USA
  • July 11 2017

In preparation for a vote this week, the House of Representatives Committee on Energy and Commerce yesterday released a new draft of the user fee