Regulatory Open Forum

Hi All,

Does any one have experience on , "FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND "fda 

We have clinical study performed in EU , we want to file 505b2 application in US.

If all ICH and GCP criteria followed, FDA agree with EU clinical study for USA application or we need to perform bridge study ?

Regards,

sapna.

------------------------------
sapna rathi
Regulatory specialist
AHME
India
------------------------------

Hi, Sapna

There is a FDA guidance relevant to your question: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions. Depending on the intended use and user of the drug, you might need to justify how the foreign data are applicable to the U.S. population and U.S. medical practice.

Best regards

May

------------------------------
May Meng, PhD, RAC
Senior Consultant
Oxford
United Kingdom
------------------------------

Original Message:
Sent: 23-Feb-2023 13:31
From: sapna rathi
Subject: EU clinical study acceptance by FDA for USA drug application

Hi All,

Does any one have experience on , "FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND "fda 

We have clinical study performed in EU , we want to file 505b2 application in US.

If all ICH and GCP criteria followed, FDA agree with EU clinical study for USA application or we need to perform bridge study ?

Regards,

sapna.

------------------------------
sapna rathi
Regulatory specialist
AHME
India
------------------------------