AUSTIN, Texas--(BUSINESS WIRE)--CDISC is proud to announce a research collaboration with the U.S. Food and Drug Administration’s Office of Translational Sciences in the Center for Drug Evaluation and ...

The US Food and Drug Administration (FDA) will begin supporting updated versions of clinical data interchange standards in the areas of reproductive toxicology and study data tabulation, effective 15 ...

Critical Path Institute (C-Path) and The Clinical Data Interchange Standards Consortium (CDISC) announce the open availability of a Duchenne Muscular Dystrophy Therapeutic Area User Guide ( TAUG-DMD ...

TUCSON, Ariz. and AUSTIN, April 16, 2019 -- The Critical Path Institute (C-Path) and CDISC are pleased to announce the release of a global Therapeutic Area Standard that specifies how to structure ...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday said it will conduct a small pilot project to test the processing and analysis of nonclinical study ...

The Huntington's Disease Regulatory Science Consortium (HD-RSC), launched in March 2018 by the Critical Path Institute (C-Path) and CHDI Foundation, today, along with the Clinical Data Interchange ...

The Clinical Data Interchange Standards Consortium ( is a global, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and ...

The Critical Path Institute (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 ...

As always, CDISC begins the year with a flurry of activity (do keep an eye on the website for regular updates and news on the standards). In addition to the CDISC standards themselves, the CDISC Board ...

AUSTIN, Texas--(BUSINESS WIRE)--The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has released the requirements of clinical trial data submission in the ...