FDA - new regulation governing foreign clinical trials
According to the 2008 revision of 21 CFR 312.120 which criteria must apply for FDA to accept data from a non-IND foreign clinical trial in support of an IND or NDA?
Drug sourced from US and trial conducted to GCP
IEC constituted according to IRB regulations and trial conducted to GCP
Information for subjects approved by FDA and trial conducted to GCP
FDA able to inspect on-site if required and trial conducted to GCP
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