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Results: 1-10 of 1,577

OIG Report Assesses Accuracy of Manufacturer-Reported Medicaid Rebate Program Data
  • Reed Smith LLP
  • USA
  • December 21 2017

The OIG recently issued a report evaluating the accuracy of pharmaceutical manufacturer-reported Medicaid drug rebate program data, including pricing


Breaking News: TH v. Novartis - California Supreme Court Recognizes New Tort Duties as Traditional Limits Slide into the Sea
  • Reed Smith LLP
  • USA
  • December 21 2017

We posted our 2017 "Worst 10 decisions" list a day too soon, because the California Supreme Court issued its anticipated decision in TH v. Novartis


FDA finalizes 3D printing guidance
  • Hogan Lovells
  • USA
  • December 20 2017

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its "leapfrog guidance" entitled, "Technical


Guest post - Observations on FDA 3D Printing Guidance
  • Reed Smith LLP
  • USA
  • December 7 2017

This guest post is by Reed Smith‘s Matthew Jacobson. It discusses the FDA’s recent guidance on the hot topic of 3D printing as a manufacturing


Unavoidably Unsafe PMA Medical Devices
  • Reed Smith LLP
  • USA
  • November 30 2017

When it comes to design defect claims and FDA pre-market approved (“PMA”) medical devices, “preemption” is our reflexive reaction. That’s entirely


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


FDA Publishes Supplemental Guidance on Menu Labeling for Chain Restaurants
  • McDermott Will & Emery
  • USA
  • November 20 2017

On November 7, the US Food and Drug Administration (FDA) published the latest in a series of industry draft guidance documents to help implement menu


FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices
  • Reed Smith LLP
  • USA
  • November 15 2017

FDA recently released guidance ("Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request") finalizing its


Non-News: Warnings Claims For A Generic Drug Preempted (Still)
  • Reed Smith LLP
  • USA
  • November 15 2017

We can be inundated with news. Old news. New news. Fake news. Breaking news. News that makes you want to break something. News that makes you want to


FDA Actions Smooth Pathway to Market for Genetic Health Risk Tests and Vitamin D Tests
  • Venable LLP
  • USA
  • November 13 2017

On November 6, 2017, the U.S. Food and Drug Administration (FDA or the Agency) announced a series of actions it is taking with regard to certain in