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CMS considers linking Medicare drug payment rates to international prices
  • Hogan Lovells
  • USA
  • October 30 2018

On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an Advance Notice of Proposed Rulemaking (ANPRM) describing a potential

Ohio Attorney General Sues Pharmaceutical Companies Over Opioid Marketing - Yet Another Sign of Government Focus on Recovering Financial Cost of Opioid Epidemic
  • Pietragallo Gordon Alfano Bosick & Raspanti LLP
  • USA
  • June 9 2017

Last week, Ohio Attorney General Mike DeWine filed a lawsuit against multiple pharmaceutical companies, including Purdue, Teva, Johnson & Johnson

New FDA Commissioner Hits the Ground Running
  • Foley & Lardner LLP
  • USA
  • May 30 2017

Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and

Third Circuit Affirms Dismissal of FCA Suit Against Genentech Based on Supreme Court’s Materiality Standard
  • McDermott Will & Emery
  • USA
  • May 10 2017

On May 1, 2017, the US Court of Appeals for the Third Circuit affirmed the dismissal of United States ex rel. Petratos, et al. v. Genentech, Inc., et

Three Senators Urge Health and Human Services Secretary to Use Statutory Authority to Allow Drugs from Canada
  • Sidley Austin LLP
  • USA
  • February 17 2017

On Feb. 14, Sens. Charles Grassley, R-Iowa, John McCain, R-Ariz., and Amy Klobuchar, D-Minn., issued a letter to Health and Human Services Secretary

FDA Addresses Off-Label Promotion in Last Week of Obama Administration
  • Baker McKenzie
  • USA
  • January 24 2017

In the last week of the Obama administration, the Food and Drug Administration (FDA or Agency) released a document titled "Memorandum: Public Health

Personalized Medicine: Insights Into Current Legal Issues
  • Foley & Lardner LLP
  • USA
  • September 18 2016

In his January 20, 2015 State of the Union Address, President Obama brought to the nation’s attention the promise of personalized medicine when he

Congress Enacts Comprehensive Addiction and Recovery Act of 2016
  • Hogan Lovells
  • USA
  • August 3 2016

On July 22, 2016, the President signed the Comprehensive Addiction and Recovery Act of 2016 (Pub. L. No. 114-198) (CARA), an expansive law intended

FDA Releases Flurry of Compounding-Related Documents
  • Quarles & Brady LLP
  • USA
  • July 19 2016

Busy, busy, busy! That is the only way to describe the FDA over the past few weeks, issuing multiple draft guidance documents affecting both 503A and

Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 5
  • Jones Day
  • USA
  • July 13 2016

On June 2, 2016, FDA announced the availability of three final guidance documents aimed at simplifying and clarifying expanded access for