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Results:1-10 of 142

Life sciences companies and free $& speech
  • Arnall Golden Gregory LLP
  • USA
  • August 19 2015

Irish and NI life sciences companies operating in the US likely are familiar with the concept of "off-label" promotion-providing information about


Another One Bites the Dust: FDA doesn’t like the fishy smell of the latest court decision on off-label dissemination
  • Arnall Golden Gregory LLP
  • USA
  • August 19 2015

The Food and Drug Administration has lost yet another court decision challenging its ability to restrict a company's commercial free speech rights


FDA issues guidance to streamline review of 510(k) submissions. A clear path forward?
  • Arnall Golden Gregory LLP
  • USA
  • August 18 2015

On August 4, 2015, the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health released a new guidance document intended


The OIG applauds FDA’s progress in inspections of generic drug manufacturers but recommends more to be done
  • Arnall Golden Gregory LLP
  • USA
  • July 23 2015

The Department of Health and Human Services' Office of Inspector General has recently recommended that the Food and Drug Administration continue to


Georgia Senator introduces the Combination Product Regulatory Fairness Act of 2015
  • Arnall Golden Gregory LLP
  • USA
  • July 21 2015

On July 17, 2015, Georgia's U.S. Senator Johnny Isakson (R-GA), along with co-sponsors, Robert Casey (D-PA), and Pat Roberts (R-KS), introduced a


US FDA updates for Irish and Northern Irish companies
  • Arnall Golden Gregory LLP
  • USA, Ireland
  • June 26 2015

AGG produces a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative


States seek to expand access to investigational drugs, biological products, and devices through “Right to Try” laws
  • Arnall Golden Gregory LLP
  • USA
  • June 24 2015

Since early 2014, at least forty states have introduced "Right to Try" laws, and twenty-two of those states have passed "Right to Try" laws. The goal


Off-label promotion, state-level injury lawsuits, and preemption
  • Arnall Golden Gregory LLP
  • USA
  • June 23 2015

The issue of preemption in product liability cases involving medical device products continues to evolve. Recently, the U.S. Court of Appeals for the


House Energy and Commerce Committee passes the 21st Century Cures Act
  • Arnall Golden Gregory LLP
  • USA
  • June 1 2015

On May 21, 2015, the House Energy and Commerce Committee unanimously approved the 21st Century Cures Act (H.R. 6). The bill aims to expand patients'


Break on through to the other side: an update on Breakthrough Therapy designation requests
  • Arnall Golden Gregory LLP
  • USA
  • May 27 2015

A recent public meeting on Breakthrough Therapy (BT) Designation after 2 years from implementation provided some interesting insight and trend