Business Wire

CDISC is Proud to Announce a Research Collaboration to Incorporate FDA Business Rules into CDISC’s Open Rules Engine (CORE)

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 ...
Houston Chronicle

(BW) FDA Announces CDISC Will Lead Industry Collaborators to Define Standards for Clinical Data Collection

AUSTIN, Texas--(BUSINESS WIRE)--July 11, 2006--On Wednesday, 21 June 2006, Janet Woodcock, FDA Deputy Commissioner for Operations and Chief Operating Officer, announced during her DIA presentation, ...
RAPS

FDA sets CDISC implementation timeline

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 ...
Medical Xpress

C-Path and CDISC announce therapeutic area user guide for Duchenne Muscular Dystrophy

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 ...
EurekAlert!

C-Path, CDISC develop therapeutic area standard to foster meaningful research for HIV

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 ...
RAPS

CDER Plots Pilot Project to Test CDISC Standard

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 ...
Business Wire

China’s Center for Drug Evaluation of the National Medical Products Administration Commits to CDISC Standards

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 ...