FDA qualifies C-Path s Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) eurekalert.org - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from eurekalert.org Daily Mail and Mail on Sunday newspapers.
Critical Path Institute and global partners establish Ataxia Consortium
Critical Path Institute (C-Path) today announced the launch of the Critical Path to Therapeutics for the Ataxias (CPTA) Consortium, a public-private partnership focused on optimizing clinical trials for inherited ataxias.
CPTA is a collaborative effort between C-Path, Ataxia Global Initiative, the National Ataxia Foundation, Ataxia UK and key partners in the industry and academic research communities, including Biohaven Pharmaceuticals, Ionis Pharmaceuticals, Roche Pharmaceuticals, Servier Group, Triplet Therapeutics, uniQure, and Vico Therapeutics. CPTA s mission is to bring together experts from across different fields of ataxia research, advocacy and medical product development to create regulatory tools and strategies that will catalyze the development of therapeutics for the ataxias, said Jane Larkindale, D.Phil., Executive Director of the Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA
C-Path and Global Partners launch Ataxia Consortium eurekalert.org - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from eurekalert.org Daily Mail and Mail on Sunday newspapers.
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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, is proud to announce the System of Hospitals for Innovation in Pediatrics - Medical Devices (SHIP-MD) Virtual Workshop to be held on February 9-11, 2021. The workshop will focus on the acceleration of medical device development for the unique needs of children.
The SHIP-MD Pre-Consortium, funded by a cooperative agreement through the FDA, is a collaboration between multiple key stakeholders including academic investigators, pediatric medical society representatives, pediatric patient advocates, the medical device industry, pediatric health system leaders and financing and reimbursement experts. The initiative is aimed at innovating the pediatric medical device ecosystem, streamlining developme
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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.