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BioPharmaceutical United States Regulation

FDA Informed Consent Guidance Under Development; HIV Studies Present Unique Challenges

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Executive Summary

When early “cure” research is unlikely to lead to study participants’ own HIV cure, the informed consent hurdle is high, patients told FDA. But will new guidance offer sufficient help and a successful path forward?

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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