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Latest report   November 2022

Safety Observer 194

ICH E19 Guideline on optimization of Safety Data Collection finalised and subsequently adopted by EMA for Europe.

Released 08-Nov-2022

Pages 36
Highlights

Past Reports

The FDA has published the final guidance on RWD and RWE Documents Submissions for Drugs and Biological Products.
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Highlights
A new FDA draft guidance explains how generic sponsors will be able to submit electronic Safety Reports to FAERS.
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Highlights
The EMA has published a list of metadata describing Real-World Data (RWD) sources and studies.
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Highlights

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