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7th Feb 2019, 03:32 PM
#1
Completing a 1572
Lots of non-USA investigators are completing a 1572 thereby committing themselves to comply with US Code of Federal Regulations, aspects of which are not possible to follow outside of the USA. FDA Guidance on this subject, published in 2010 indicates the need for foreign investigators working under an IND to apply to the FDA for a waiver. Is anyone aware of this happening and if so, what is the process for submitting a waiver and the timeline for response? What is MHRA's view on UK investigators signing a 1572?
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