China makes switch to faster approval system for imported drugs
NMPA and National Health Commission of China have established faster system to review and approve on urgently needed new drugs that have been approved in other countries
Read
EMA eSource Direct Data Capture (DDC) qualification opinion issued
the regulatory acceptability to use an eSource Direct Data Capture in Clinical Trials
Read the pdf Read
FDA Facilitates the Use of Surrogate Endpoint in Drug Development
CDER small business and industry assistance podcast news from November 2018
Read more online Read
EMA use of patient disease registries for regulatory purposes
Methodological and operational considerations by a cross-committee task force on Registries
Read more online Read
EMA Draft questions and answers on Data Monitoring Committees issues
A Supplement to the CHMP Data Monitoring Committee Guideline
Read more online Read
Copyright Widler & Schiemann AG 2015. All Rights Reserved. /