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Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
  • Ropes & Gray LLP
  • USA
  • April 12 2018

The rules regarding truthful, non-misleading communications by medical product manufacturers have long been unclear. In recent years, there have been


Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar
  • Skadden Arps Slate Meagher & Flom LLP
  • USA
  • March 29 2018

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused


Minnesota Court Excludes Plaintiff Expert Opinions For Lack of General Acceptance
  • Reed Smith LLP
  • USA
  • March 21 2018

All of us - defense lawyers, plaintiff lawyers, and judges - tend to assume that the federal Daubert standard for admissibility of expert testimony is


DOJ Confirms Involvement in Opioid Litigation, Sheds Light on Potential Claims
  • Sidley Austin LLP
  • USA
  • March 9 2018

In a series of speeches over the last week, DOJ has expanded on its commitment to organize enforcement efforts focused on manufacturers and


"Off-label" Cases Aren't Going Away - DOJ Sheds Light on Direction of Enforcement of Misbranding Rules Governing Medical Products
  • Venable LLP
  • USA
  • March 6 2018

On February 28, Ethan Davis, the U.S. Department of Justice's (DOJ) deputy assistant attorney general responsible for consumer protection, gave a


New DOJ Task Force to Take on Opioid Crisis Using the FCA and Other Enforcement Tools
  • McDermott Will & Emery
  • USA
  • March 2 2018

Earlier this week, the US Department of Justice (DOJ) launched a new front in its effort to combat the opioid crisis and explicitly stated that it


New DOJ Policy Restricts FDA Authority to Take Enforcement Action Based on Guidance Documents
  • Troutman Sanders LLP
  • USA
  • February 28 2018

On January 25, 2018, the United States Department of Justice (“DOJ”) announced a new policy that bars DOJ from using its enforcement authority to


DOJ Memoranda Limit the Use of Guidance Documents in Civil Actions
  • Hogan Lovells
  • USA
  • February 27 2018

As seen in news reports, two recent Department of Justice (DOJ or Department) memoranda address the role of guidance documents in civil enforcement


New DOJ Guidance Policy Limits Use of Guidance Documents in Federal Civil Actions
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • February 20 2018

On January 25, 2018, Associate Attorney General Rachel Brand issued a memorandum on behalf of the U.S. Department of Justice (DOJ) (the “Brand


New DOJ Policy Says Government Lawyers Cannot Base Enforcement Actions on Guidance Documents
  • Keller and Heckman LLP
  • USA
  • February 14 2018

As our readership is well aware, the U.S. Food and Drug Administration (FDA) frequently issues guidance documents for all areas under its regulatory