News & Events

• 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

• September 23, 2019
  

  Development of a Neonatal Adverse Event Severity Scale Through a Delphi Consensus Approach