From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information
FDA Law Blog
OCTOBER 24, 2023
Firm-generated communications must meet the general recommendations in the Draft Guidance and “should be truthful, non-misleading, factual and unbiased and provide all information necessary for HCPs to interpret the strengths and weaknesses and validity and utility of the presented information.”
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