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Pharmaceutical Digital Health Innovators Take Note: FDA Public Hearing on an Innovative Approach to Devices Referencing Drugs
  • Covington & Burling LLP
  • USA
  • November 15 2017

On November 16, 2017, the Food and Drug Administration ("FDA" or the "Agency") will hold a public hearing on a proposed approach for sponsors seeking

The Internet of Pills: The FDA’s Approval of Digital Smart Pills Takes the Internet of Things to New Levels
  • Gordon Rees Scully Mansukhani
  • USA
  • November 15 2017

If your insurance company knew that you did not take your medication as prescribed, could it deny future coverage? Could your physician refuse to

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

Louisiana Adopts Price Reporting Law
  • Kelley Drye & Warren LLP
  • USA
  • November 13 2017

A new law in Louisiana requires drug manufacturers to report wholesale acquisition cost (WAC) information directly to the state. Louisiana law defines

Ready to Release a New Pharmaceutical? What to Think About When Selecting Your Drug Name
  • Foley & Lardner LLP
  • USA
  • November 8 2017

Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and

CNN Investigates Expanding Use of Nuedexta in Nursing Homes
  • Stark & Stark
  • USA
  • October 16 2017

A recent investigation by CNN brought to light the expanding and allegedly inappropriate use of the prescription drug Nuedexta in nursing homes

Clinical trials in China
  • Ropes & Gray LLP
  • China, Global
  • October 12 2017

A structured guide to clinical trials in China

California Governor Considers Drug Price Reporting Bill and Ban on Discounts and Rebates for Branded Pharmaceutical Products
  • Cooley LLP
  • USA
  • September 18 2017

The California State Legislature sent two new pharmaceutical pricing measures, S.B. 17 and A.B. 265, to Governor Jerry Brown on September 13th. S.B

FDA Clarifies Trading Partners Under the DSCSA
  • Reed Smith LLP
  • USA
  • September 14 2017

The Federal Food and Drug Administration ("FDA") recently published a draft guidance to assist industry and State and local governments in

The legal and regulatory challenges of getting a biosimilar product to market
  • CMS
  • 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