Fda periodic safety update reports5/1/2023 ![]() PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. This page includes information on periodic safety update reports (PSURs), PSUR submission requirements, PSUR single assessment procedures (PSUSAs) and the European Union reference dates (EURD) list. Submitting a post-authorisation application.Post-authorisation efficacy studies (PAES).Direct healthcare professional communications.Changing the labelling and package leaflet (Article 61(3) notifications). ![]() ![]() Changing the (invented) name of a medicinal product. ![]()
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