Hi all,
I'm wondering if anyone has any experience with requesting permission from the FDA to use a CIOMS I form for domestic safety reporting instead of a MedWatch 3500A form. Specifically with respect to the timing of response to these requests.
Per 21 CFR 312.32(c)(1)(v): "
The sponsor may submit foreign [emphasis added] suspected adverse reactions on a Council for International Organizations of Medical Sciences (CIOMS) I Form instead of a FDA Form 3500A." Associated guidance documents state that the CIOMS I can be used for foreign reports without the need for prior submission from the FDA. However, it is still expected that domestic safety reports will be submitted on a MedWatch 3500A form.
For sponsors conducting a study in the US and at least one other country, my understanding is that it's possible to request permission from the FDA to submit domestic safety reports on a CIOMS I in order to avoid duplication of data across two forms. Otherwise we'd have to capture the same info for each domestic SAR onto two different forms in order to submit to the different health authorities.
Does anyone have experience with requesting permission from the FDA to use the CIOMS I form for domestic safety reports? If so, how long did it take the FDA to respond? Were you successful in your request?
Thanks!------------------------------
Marissa Berry, Ph.D., RAC
Manager, Global Regulatory Affairs
Cary, NC
United States
------------------------------