Safety Observer 202
CIOMS has published the draft report of Working Group XII on Benefit-Risk Assessment.
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New FDA Draft Guidance
The FDA has published for comments a new draft guidance entitled “Psychedelic Drugs: Considerations for Clinical Investigations”.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.
