Asked by: Amrani Canut
asked in category: General Last Updated: 30th May, 2020

What is FDA Form 3500a?

Form FDA 3500A - Mandatory Reporting and Instructions for Completing Form FDA 3500A. Mandatory reporting For use by IND reporters, manufacturers, distributors, importers, user facilities personnel.

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Hereof, 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.

Beside above, 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.

Likewise, 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.

How do I report to the FDA?

Report a problem with FDA-regulated products

  1. Call 1-888-INFO-FDA (1-888-463-6332).
  2. Call the FDA Consumer Complaint Coordinator for your state or region.

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