News & Events
News & Events
October 15, 2019
C-Path, CDISC Develop Standard to Represent Data for Animal Rule Studies
C-Path and CDISC are pleased to announce the release of a global Foundational Standard that describes how to represent data for the natural history and efficacy studies conducted in animals submitted to applications under the U.S. Food and Drug Administration (FDA) regulations commonly known as the Animal Rule.
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 30, 2019
The Critical Path for Parkinson’s Consortium (CPP) welcomes PMD Alliance as newest memberThe Critical Path for Parkinson’s Consortium (CPP) is thrilled to welcome the PMD Alliance (Parkinson & Movement Disorder Alliance) as our newest member. The PMD Alliance is an independent, national nonprofit organization that provides opportunities for people impacted by Parkinson’s and other movement disorders to learn, live life more fully, and connect with others. Their...
- September 25, 2019
- September 23, 2019