Biomarkers and Subparts Rules and Exceptions. James Witter MD, PhD Analgesic, Anti-inflammatory, and Ophthalmologic Drug Products HFD-550/ODEV/CDER/FDA. FDA and Medical Care. The FDA approves drug and biologic therapeutics for interstate commerce The FDA does not regulate medical care
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James Witter MD, PhD
Analgesic, Anti-inflammatory, and Ophthalmologic Drug Products
FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible mortality.
Clinically Meaningful Outcome Drug for Human Use (Form FDA 356H)