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July 2023

Safety Observer 202

CIOMS has published the draft report of Working Group XII on Benefit-Risk Assessment.

Released 07-Jul-2023
Pages 36
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Report 202 — Highlights

CIOMS XII: BRA

CIOMS has launched a public consultation on the draft report of Working Group XII, which provides an overview of Benefit-Risk Assessment (BRA) methods.

ICH consults on RWE

ICH is calling for comments on a Reflection Paper for the International Harmonisation of Real-World Evidence (RWE) Terminology.

FDA Guidance for DTC ads

The FDA has published the final guidance entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements”.

New FDA Draft Guidance

The FDA has published for comments a new draft guidance entitled “Psychedelic Drugs: Considerations for Clinical Investigations”.

Egypt GVP Guideline

The EDA (Egyptian Drug Authority) has published a new version of the Guideline on Good Pharmacovigilance Practice (GVP) in Egypt.

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