Log in
RegisterSAE Reporting [Regulatives / Guidelines]
Dear Sir,
Recently we had a BE study in India for USFDA submission in which one subject had a SAE. As per Indian regulation we had reported SAE to Sponsor and Indian regulatory Authority within the stipulated timeline. My question is that as my BE reference product is from US and BE study submission is to USFDA, can I have to report the SAE to USFDA regulatory Authority also.
Kindly give your suggestions.
Regards,
Santosh
Recently we had a BE study in India for USFDA submission in which one subject had a SAE. As per Indian regulation we had reported SAE to Sponsor and Indian regulatory Authority within the stipulated timeline. My question is that as my BE reference product is from US and BE study submission is to USFDA, can I have to report the SAE to USFDA regulatory Authority also.
Kindly give your suggestions.
Regards,
Santosh
Complete thread:
- SAE Reportingsantosh 2013-01-16 08:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- SAE Reporting drgunasakaran1 2013-01-17 04:02
- SAE Reporting luvblooms 2013-01-17 05:49
Ing. Helmut Schütz