News & Events

• June 19, 2020
  

  Method of Blood Pressure Measurement in Neonates and Infants: A Systematic Review and Analysis

  The latest INC manuscript, courtesy of the Hemodynamic Adaptation Workgroup, is now published in The Journal of Pediatrics. Access ‘Method of Blood Pressure Measurement in Neonates and Infants: A Systematic Review and Analysis’ (Volume 221, June 2020, Pages 23-31.e5) here.

• November 18, 2019
  

  Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials

• October 22, 2019
  

  Evaluation of multiple sclerosis disability outcome measures using pooled clinical trial data

• October 9, 2019
  

  On September 25th, the FDA published a Personal Viewpoint in the American Journal of Transplantation

  This Personal Viewpoint is in response to a whitepaper published by the TTC titled “The Importance of Drug Safety and Tolerability in the Development of New Immunosuppressive Therapy for Transplant Recipients”.

  This article provides a FDA perspective on the whitepaper, the overall TTC effort, and public-private partnerships with authors from the Office of New Drugs, Office of Translational Sciences, and Clinical Outcome Assessment staff in CDER.

• September 25, 2019
  

  Assessment of Long-term Neurodevelopmental Outcome Following Trials of Medicinal Products in Newborn Infants