RWD & RWE in FDA submissions
New Draft Guideline on Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
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ICH E8 under revision
The ICH Guideline “General Considerations for Clinical Trials” is under revision and has been issued for public comments
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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
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Significant advancements in global harmonization efforts at ICH’s largest biannual meeting to-date
Sixteen Members and twenty-eight Observers met in Amsterdam
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EMA eSource Direct Data Capture (DDC) qualification opinion issued
the regulatory acceptability to use an eSource Direct Data Capture in Clinical Trials
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