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It is not a comprehensive list of COAs and is not intended to replace either existing disease-specific guidance or key interactions with FDA concerning drug development (e.g., pre-IND meetings) Inclusion of a COA in the COA Compendium does not necessarily indicate that the measure is or should be the primary or sole determinant of effectiveness in a clinical trial nor is it indicative of endpoint positioning (e.g., primary or secondary) The COA Compendium presents information that was available at the time it was compiled and updated; it may not include newer COAs that could be recommended for a drug development program, or more recent scientific and regulatory thinking It does not include biomarkers with the exception of biomarkers used in composite endpoints It does not include the endpoint definition of labeled COAs Some of the COAs listed in the COA Compendium may be protected by proprietary rights and, in some cases, a royalty and fee may be charged by the copyright owners for their authorized use. He says his department is regularly confiscating pot from Colorado. Food and Drug Administration, etc.) Additionally, TerraSave took in children who were orphaned by Bio-Terrorism as its wards. Lorrie and Dennis Brewer have been in the furniture business for years but will attend their first High Point Market this month.
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