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CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.32
- Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may...
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803&showFR=1
- (c) Caused or contributed means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have …
European Medicines Agency
- https://www.ema.europa.eu/en/documents/other/designated-medical-event-dme-list_en.xlsx
- Designated Medical Event (DME) list Note: As a help to prioritise the review of reports of suspected Adverse Drug Reactions (ADRs) in the framework of the day to day …
FDA Publishes List of Essential Medicines, Medical …
- https://www.fda.gov/news-events/press-announcements/fda-publishes-list-essential-medicines-medical-countermeasures-critical-inputs-required-executive
- Over the past several weeks, the FDA has worked, in consultation with other federal partners, to develop a list of 227 drug and biological product essential medicines …
Signal management | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management
- The designated medical event list is one of the tools the European medicines regulatory network uses and is not intended as a comprehensive list of terms for signal …
Department of Health and Human Services Public …
- https://www.fda.gov/media/111561/download
- labeled events were related to skin events, gastrointestinal disorders, specific seizure types, and central nervous system effects. These adverse events are adequately described in …
Definitions and difference in PVG terms: Designated …
- https://www.linkedin.com/pulse/definitions-difference-pvg-terms-designated-medical-dr-aditi
- • This IME list aims to facilitate: 1- The classification of suspected adverse reactions 2- The analysis of aggregated data 3- Assessment of ICSRs in the framework …
EMA Releases List of Medical Events for …
- https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2016/8/ema-releases-list-of-medical-events-for-pharmacovigilance-monitoring
- The European Medicines Agency (EMA) has released a list of standardized terms describing medical events it says will be used by the agency and other …
Important Medical Events list – version 23.1 – Updates
- https://allaboutpharmacovigilance.org/important-medical-events-list-version-23-1-updates/
- 8. Surgical and medical procedures terms that imply that an IME has occurred are excluded 9. “Elective abortion” terms are excluded 10. Nonspecific …
Designated Medical Event (DME) list - VigiServe …
- https://www.vigiservefoundation.org/inopp/topic/designated-medical-event-dme-list/
- As a help to prioritise the review of reports of suspected Adverse Drug Reactions (ADRs) in the framework of the day to day pharmacovigilance activities the …
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