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jonjones325:This is a brilliant contribution. More study required

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nidan7500   Thursday, 05/30/19 08:38:42 AM
Re: Jonjones325 post# 194786
Post # of 232454 
jonjones325:This is a brilliant contribution. More study required to get it all but it does fit what we are puzzled over. The concept and rules are clearly understood here. Cannot help but wonder how FDA-BP feel about losing control. Is this what Dr.G saw?

taken from stack...did not compile well..regrets
Quote:
Following ICH-E51, FDA does not require studies that are conducted solely outside the U.S. to be performed under an Investigational New drug Application (IND) In the U.S., CFR 21.314.106 governs which foreign data are acceptable. • local data is not needed if three criteria are met: – The foreign data must be “relevant and applicable” to the US population. – The foreign studies must be performed by competent investigators. – The FDA must have confidence in and the ability to validate or verify the data. 3
– An application based solely on foreign clinical data may be approved if data are applicable to the US population and medical practice. – The FDA may require a “bridging study” if it is concerned about the applicability of a study’s results to its population. 4



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