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Life Sciences: product regulation and liability in China
  • Ropes & Gray LLP
  • China, Global
  • July 31 2018

A structured guide to product regulation and liability laws in China


Clinical trials in China
  • Ropes & Gray LLP
  • China, Global
  • July 31 2018

A structured guide to clinical trials in China


Pharmacovigilance in China
  • Ropes & Gray LLP
  • China, Global
  • July 31 2018

A structured guide to Pharmacovigilance in China


FDA aims to foster gene therapy developments with six new draft guidance documents
  • Hogan Lovells
  • USA
  • July 11 2018

This morning, FDA’s Center for Biologics Evaluation and Research (CBER) published six draft guidances relating to gene therapy, three of which cover


New Federal Right To Try Act Poses Practical and Ethical Dilemmas for Physicians
  • Dykema Gossett PLLC
  • USA
  • June 29 2018

On May 30, 2018, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (“Right To Try Act,” or “Act”)


Pharma Plays the Medical Card: How Will The DEA Respond?
  • Lane Powell PC
  • USA
  • June 26 2018

Due to some interesting developments in health science, the future of the industrial hemp industry may be in the hands of the DEA once again. For the


A new right for American patients: The Right to Try
  • Hogan Lovells
  • USA
  • May 25 2018

On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the "Right to Try Act of 2017" by a vote of 250-169. The


Citing Lack of Standing, D.D.C. Tosses Challenge to FDA Denial of Citizen Petition
  • Reed Smith LLP
  • USA
  • May 9 2018

If clients get sued by someone where physical or financial injury seems remote, unclear, or speculative, consider raising the defense of lack of


FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials
  • Hogan Lovells
  • USA
  • April 18 2018

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies


Additional Discovery of Clinical Trial Data in Inter Partes Review
  • Baker & Hostetler LLP
  • USA
  • March 30 2018

In Apotex, Inc. et al. v. Novartis AG (IPR 2017-00854, paper 47 dated Feb. 5, 2018), petitioner Apotex sought, and was granted, discovery of a Phase