
(AGENPARL) – SILVER SPRING lun 10 aprile 2023 FDA is issuing this guidance to communicate its temporary policy for certain risk evaluation and mitigation strategies (REMS) requirements for the duration of the public health emergency (PHE) declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.
Fonte/Source: http://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-certain-rems-requirements-during-covid-19-public-health-emergency-guidance-industry-and