Asked by: Yifei Silverioasked in category: General Last Updated: 9th February, 2020
What is a MedWatch Form 3500?
Besides, what should I report to MedWatch?
If you need information or if you have questions or comments about a medical product, please call the FDA's toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2 to report into MedWatch or for instructions.
Beside above, who oversees the Faers program? The Food and Drug Administration (FDA), a regulatory agency within the Department of Health and Human Services, regulates the safety and effectiveness of drugs sold in the United States. FDA divides that responsibility into two phases.
Just so, which type of form is used by health professionals to report adverse drug events to the FDA?
FDA Form 3500 should be used by healthcare professionals and FDA Form 3500B should be used by patients or consumers for voluntary reporting of adverse events noted spontaneously in the course of clinical care.
Does FDA accept Cioms forms?
FDA has decided, based on comments to its postmarketing safety reporting regulations (see section IV. F of this document), to amend Sec. 312.32(c)(1) to permit use of the CIOMS I form for reporting foreign events without prior approval.