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RegisterSAE Reporting [Regulatives / Guidelines]
Dear Mr Santosh,
Yes, We need to report the SAE to FDA. Usually, it is the responsibility of the Sponsor to report the SAE to the USFDA since the BE study was meant for US FDA submission. However, the CRO can also report the SAE to US FDA.
❝ 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.
Yes, We need to report the SAE to FDA. Usually, it is the responsibility of the Sponsor to report the SAE to the USFDA since the BE study was meant for US FDA submission. However, the CRO can also report the SAE to US FDA.
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Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Complete thread:
- SAE Reporting santosh 2013-01-16 08:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- SAE Reportingdrgunasakaran1 2013-01-17 04:02
- SAE Reporting luvblooms 2013-01-17 05:49
Ing. Helmut Schütz