CDISC updates this page with announcements from regulatory authorities (FDA, PMDA, EMA, etc.). We encourage readers to check for new announcements directly with the appropriate agency.
Announcements
From FDA:
- Data Standards Catalog (September 2016) specifies using CDISC Controlled Terminology, SEND, SDTM, ADaM, and Define-XML standards.
- Study Data Technical Conformance Guide (March 2017) specifies rules for using CDISC standards on submissions to FDA CDER and CBER.
- Study Data Standards: What You Need to Know (June 2016)
- Section 5 of Prescription Drug User Fee Act (PDUFA) VI Proposed Commitment Letter addresses “Enhancing Capacity to Support Analysis Data Standards for Product Development and Review.”
- Guidance on Providing Regulatory Submissions in Electronic Format (December 2014) requires submissions in an electronic format specified by the agency beginning 24 months from the issuance of this document.
From PMDA:
- FAQs in English on Electronic Study Data Submission (February 2017)
- Advanced Review with Electronic Data Promotion Group
- Notification on Practical Operations of Electronic Study Data (April 2015)
- Question and Answer Guide Regarding Notification on Practical Operations of Electronic Study Data Submissions (April 2015)
- Technical Conformance Guide on Electronic Study Data Submissions (April 2015)
- PMDA Data Standards Catalog (March 2017)
From China FDA (CFDA):
- CFDA has endorsed CDISC standards in their Clinical Trial Data Management Technology Guide (July 2016)