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    Together this information can establish the clinical validity of a biomarker for a specified COU. When you leave our website, we encourage you to read the privacy notice of every website you visit. An appendix may appear at the section, subpart, or part level.

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    FDA evaluates when determining areas of nonclinical flexibility include the pharmacological and chemical characteristics of the drug, the design and objectives of the proposed clinical investigations, the anticipated risks to humans, and the existing accumulated nonclinical toxicology and human data.

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    Alternative trial designs and statistical techniques are critical in maximizing data from a small, potentially heterogeneous group of participants, as is often the case for rare diseases.

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    The draft guidance also does not incorporate all the principals that the Agency has publicly communicated elsewhere with regard to innovative approaches to clinical trial design and regulatory flexibility in this space.

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    It is therefore left to investigators to perform studies to demonstrate the relationship of these endpoints to outcomes that are considered to be clinically relevant by regulators, investigators, and the patient community.

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    Learn about key points of FDA's updated guidance for rare diseases including natural history studies clinical outcomes assessments and patient engagement.

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11 Ways to Completely Sabotage Your Fda Natural History Guidance

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