B
Bunny
If we are running an clinical trial in the US and a separate clinical trial in Europe and an adverse event occurs in the European trial, must we notify the US FDA?
Separate Clinical Trials in the US and the EU - When one fails - question
D
domche
With reference to the FDA CFR PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION, Subpart B--Investigational New Drug Application (IND),
Sec. 312.32 IND safety reporting. Look at the FDA website and search 312.32 IND safety reporting.
(Sorry but the Elsmar forum does not allow links for new members, even part of a link, in case a FDA link would be a spam!!)
In other words, what is known outside of the US should be reported to the US and what is known in the US should be reported in particular to Europe Authorities (EMA).
Safety reporting rules must be established, maintained and strictly applied.
Dominique
Sec. 312.32 IND safety reporting. Look at the FDA website and search 312.32 IND safety reporting.
(Sorry but the Elsmar forum does not allow links for new members, even part of a link, in case a FDA link would be a spam!!)
In other words, what is known outside of the US should be reported to the US and what is known in the US should be reported in particular to Europe Authorities (EMA).
Safety reporting rules must be established, maintained and strictly applied.
Dominique
