The FDA has published the final guidance to explain how to submit information on postmarketing requirements (PMRs) and postmarketing commitments (PMCs).
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.
The FDA has published a new draft guidance describing how confirmatory evidence may suffice to complement a single clinical investigation to demonstrate effectiveness.
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.
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