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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

Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 6
  • Jones Day
  • USA, United Kingdom, European Union
  • August 3 2016

FDA recently released, as a part of President Obama's Precision Medicine Initiative, two draft guidance documents proposing what the Agency is

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

FDA Approves First MRI-Guided Ultrasound Device to Treat Essential Tremor
  • Knobbe Martens
  • USA
  • July 12 2016

The FDA recently approved INSIGHTEC's Premarket Approval ("PMA") application for ExAblate Neuro, a device designed to treat essential tremor

If you don't eat your medicine, you can’t have any pudding!
  • Venable LLP
  • USA
  • August 29 2013

On August 13th, the Food and Drug Administration (FDA) released a second version of its draft guidance on medical foods. The draft guidance

Health care professionals and certificates of medical necessity under FDA consent decrees
  • Foley & Lardner LLP
  • USA
  • April 19 2011

Hospital legal counsel and compliance officers are familiar with the legal ramifications of certifying to medical necessity in the context of Medicare, Medicaid, and other payor reimbursement rules.

Off-label uses held "medically accepted" as a matter of law
  • Dechert LLP
  • USA
  • March 18 2011

Could the FDA prosecute a drug manufacturer for sending a copy of a judicial opinion to its customers?

Premature development causes unease in China
  • Shook Hardy & Bacon LLP
  • USA, China
  • August 20 2010

Chinese health experts have reportedly estimated that "at least 30,000 children developed early maturity" in Shanghai alone, raising concerns about food additives and pesticides allegedly laden with sex hormones.

Two off-label marketing pharmaceutical company settlements
  • Bricker & Eckler LLP
  • USA
  • June 7 2010

On May 4, 2010, the DOJ announced another off-label drug settlement, this one with Novartis.

The case for regulating laboratory-developed tests
  • Epstein Becker Green
  • USA
  • December 1 2009

For years, the IVD industry, clinical laboratories, and patient groups have debated the appropriate regulatory scheme for laboratory-developed tests (LDTs).