EXTEDO Blog | EXTEDO

The EMA published the FHIR Conceptual Data Model (CDM)

US FDA Adverse Event Reporting System (FAERS) Electronic Submissions

EMA Publishes New Timeline For DADI Project

US FDA Adopts ICH Clinical Trials Guideline with Exclusive Reference to E2B(R3) Standards

CMDh Updates Guidelines to Implement Northern Ireland Protocol (Brexit relevant information)

US FDA announces that DTD version 3.3 will be made mandatory for eCTD submissions

Use of E2B(R3) Becomes Mandatory June 2022 - How to Prepare

EU Clinical Trials Regulation Now in Effect

EMA Updates Technical Guidance for eCTD Submissions in the EU

MHRA updates Guidance for Centrally Authorized Products (CAPs) to UK Marketing Authorization (MAs)

New EU Guidance on Data Submission for Investigational Medicines

Australia readies itself for eCTD only