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FDA to Hold Public Hearing on Youth E-Cigarette Cessation
  • Troutman Sanders LLP
  • USA
  • November 13 2018

On December 5, 2018, FDA will hold a public hearing to discuss its efforts to eliminate youth e-cigarette and other tobacco product use. One of the

Putative Securities Class Action Dismissed Against Biopharmaceutical Company Where Statements Regarding Clinical Trials Were Not Actionable And Plaintiffs Failed To Plead Scienter
  • Shearman & Sterling LLP
  • USA
  • November 6 2018

On October 26, 2018, Judge Thomas D. Schroeder of the United States District Court for the Middle District of North Carolina dismissed a putative

Demand for Marijuana About to Heat Up?
  • Bennett & Philp Lawyers Pty Ltd
  • Australia
  • October 24 2018

Marijuana (also known as cannabis and by several other names) has been used throughout most of recorded history for medicinal, spiritual and

Clinical trials in France: improved designation process of the competent ethical committees (CPPs)
  • Bird & Bird
  • France
  • October 24 2018

In France, the conduct of clinical trials requires a prior express favourable opinion of a Comité de protection des personnes (CPP), in English

Clinical Trial Liability Revisited, Briefly
  • Reed Smith LLP
  • USA
  • October 17 2018

There was a time when we paid quite a bit of attention to the circumstances under which a participant in a clinical trial could impose liability on

New Draft Guidance on Adaptive Designs for Clinical Trials
  • Epstein Becker Green
  • USA
  • October 16 2018

Two draft guidances issued together late last month seek to increase both clinical trial efficiency and the amount of information that is available

Does your clinical trial pass the GDPR test?
  • Loyens & Loeff
  • European Union
  • October 11 2018

Since 25 May 2018, the General Data Protection Regulation ("GDPR") is applicable throughout Europe. Strictly regulating the processing of health data

MHRA opens consultation on ‘no deal’ contingency legislation for the regulation of medicines and medical devices
  • Baker McKenzie
  • United Kingdom, European Union
  • October 10 2018

On 4 October 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) opened a consultation on how its legislation and regulatory

Deal or No Deal - Government opens the (first) box
  • Cooley LLP
  • United Kingdom, European Union
  • October 9 2018

The UK Government has been publishing technical notices, setting out its plans in the event that the UK and the EU fail to reach agreement before

California Consumer Privacy Act: The Challenge Ahead - Four Key Considerations for Health and Life Sciences Companies
  • Hogan Lovells
  • USA
  • October 8 2018

The California Consumer Privacy Act of 2018 (CCPA) adds another set of privacy requirements for health and life sciences companies. Managing the