Asked by: Shani Ekmanasked in category: General Last Updated: 13th March, 2020
Who can report an adverse event AE?
Keeping this in view, what government agencies should adverse events be reported to?
ADEs can be reported directly by the HCP or consumer to the FDA using MedWatch, or they can be reported to the manufacturer who in turn reports them to the FDA (FIGURE 1).
Also Know, when Should non serious adverse events AEs be reported to the sponsor? Related and unexpected fatal or life–threatening AEs (severity grade 4 or 5) that are associated with the use of the drug must be reported to FDA by telephone or fax no later than 7 calendar days after the sponsor first learns of the event.
Hereof, how do I report an adverse drug event to the FDA?
Submitting Adverse Event Reports to FDA
- Report Online.
- Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission.
- Call FDA at 1-800-FDA-1088 to report by telephone.
- Reporting Form FDA 3500 commonly used by health professionals. View Instructions for Form FDA 3500.
What is considered an adverse event?
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.