Safety Observer 204
New requirements for the Medical Assessment of cases reported to Swissmedic.
Report 204 — Highlights
FDA: PMRs and PMCs
The FDA has published the final guidance to explain how to submit information on postmarketing requirements (PMRs) and postmarketing commitments (PMCs).
FDA & Clinical Trial Disruptions
The FDA has published a new final guidance describing approaches that can be considered when there is a major disruption to clinical trial conduct due to public health emergencies or disasters.
New FDA Draft Guidance
The FDA has published a new draft guidance describing how confirmatory evidence may suffice to complement a single clinical investigation to demonstrate effectiveness.
Switzerland ADR Reporting
The Swiss Agency has updated its Pharmacovigilance guidance, which bring new requirements for the Medical Assessment of cases reported to Swissmedic from 01-Jan-2024.
