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What is a Serious Adverse Event? | FDA
- https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event
- Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes. Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, seri… See more
Medical Product Safety Information | FDA
- https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/medical-product-safety-information
- MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The …
Expedited Safety Reporting Requirements for Human …
- https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/expedited-safety-reporting-requirements-human-drug-and-biological-products
- In the Federal Register of June 3, 1993 (58 FR 31596), FDA announced the availability of a new form for reporting single cases of adverse events and product problems with …
IND Application Reporting: Safety Reports | FDA
- https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-reporting-safety-reports
- Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.32
- The following definitions of terms apply to this section: Adverse event means any untoward medical occurrence associated with the use of a drug in humans, …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=600.80
- Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse experience when, based …
Instructions for Completing Form FDA 3500 | FDA - U.S.
- https://www.fda.gov/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500
- Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality …
Inclusion/exclusion criteria for the “Important Medical …
- https://www.ema.europa.eu/en/documents/other/inclusion-exclusion-criteria-important-medical-events-list-meddra_en.pdf
- “important medical event” as noted below: A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: * results in death, * is life …
European Medicines Agency
- https://www.ema.europa.eu/en/documents/other/meddra-important-medical-event-terms-list-version-250_en.xlsx
- PT Head crushing injury was added in V25.0 and meets the ICH definition of seriousness and of an “important medical event”: "A serious adverse event (experience) or reaction …
Important Medical Events list – version 23.1 – Updates
- https://allaboutpharmacovigilance.org/important-medical-events-list-version-23-1-updates/
- Important Medical Events list - version 23.1 - Updates | Pharmacovigilance The EudraVigilance Expert Working Group (EV-EWG) has coordinated the development …
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