News & Events
News & Events
February 9, 2021 - February 11, 2021
SHIP-MD 2021 Virtual Workshop
Join Us February 9th, 10th, 11th 2021
Free Public Virtual Meeting and Workshop
All stakeholders interested in pediatric medical device development are invited to a dynamic 3-day virtual public meeting developed and guided by a multi-stakeholder group including C-Path, the U.S. Food and Drug Administration, AdvaMed, American Academy of Pediatrics, and leaders of pediatric health systems.
January 21, 2021 - January 21, 2021
Webinar: RDCA-DAP and EATRIS Present Rare Disease Drug Development
January 21, 2021 | 5:00 p.m. – 6:30 p.m. CET
Data Sharing and Analysis to Support Rare Disease Drug Development
The European Infrastructure for Translational Medicine, EATRIS, has invited the Rare Disease Cures Accelerator-Data and Analytics Platform team to present as part of its webinar series, EATx, to introduce RDCA-DAP to the European academic and industry audience. The webinar will discuss how RDCA-DAP works with European entities and how data sharing within Europe, and between Europe and other countries, can be achieved with RDCA-DAP.
January 14, 2021
C-Path Announces SHIP-MD 2021 Virtual WorkshopMulti-stakeholder event will focus on national innovation ecosystem for pediatric medical device development TUCSON, Ariz., January 14, 2021 — The Critical Path Institute (C-Path) in collaboration with the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) AdvaMed, the American Academy of Pediatrics (AAP) and multiple pediatric health system leaders,...
January 8, 2021
Effective Data Sharing as a Conduit for Advancing Medical Product DevelopmentPatient-level data sharing has the potential to significantly impact the lives of patients by optimizing and improving the medical product development process. In the product development setting, successful data sharing is defined as data sharing that is actionable and facilitates decision making during the development and review of medical products. This often occurs through the...
January 7, 2021
Diary for Irritable Bowel Syndrome Symptoms-Constipation is the First Patient-Reported Outcome Consortium Measure Used to Support an FDA-approved Label Claim
TUCSON, Ariz., January 7, 2021 — Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces that clinical study results using the Consortium’s Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) were recently included in the expanded label for the drug LINZESS® (linaclotide). The DIBSS-C was developed by the PRO Consortium’s Irritable Bowel Syndrome (IBS) Working Group to support the evaluation of both primary and key secondary endpoints related to improvements in IBS-C signs and symptoms within the context of clinical trials and is currently in FDA’s Clinical Outcome Assessment Qualification Program. Although the DIBSS-C was not specifically mentioned, results from its abdominal symptom scale were included in the updated label for LINZESS®. This is the first time a PRO Consortium measure has been used to support a label claim.