![]() ![]() List the brand and generic name of approved drugs, date of approval for NME labeling and the most recent approval date for efficacy supplements. The definition of underground storage tank at 40 CFR 280.12 exempts tanks used to store heating oil for consumptive. Tools listed in Column 3 were found in labeling for all drugs listed in Column 5, with the exception of those denoted with a superscript Answer: The 2015 UST regulation discusses partial and complete exclusions from applicability in 40 CFR 280.10 and definitional exemptions in 40 CFR 280.12 (see the definition of underground storage tank). COA Type (i.e., a patient-reported outcome, observer-reported outcome, clinician-reported outcome, or performance outcome tool).COA as listed in labeling or the qualification statement.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 useĭescribes circumstance under which the COA has been used (i.e., labeled) or has been qualified (for qualified tools under CDER’s DDT Qualification program)ĭescribes the concept that the COA measures It does not include the endpoint definition of labeled COAs It does not include measures of survival with the exception of use in composite endpoints ![]() It does not include biomarkers with the exception of biomarkers used in composite endpoints 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 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) Users may access the Laboratory Compendium from anywhere using a secure Internet connection. This definition of the word compendium is from the Wiktionary, where you can also find the etimology, other senses, synonyms, antonyms and examples. Visit to browse the Web site and complete the online registration. Do you know the meaning of compendium A short, complete summary an abstract. 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., during pre-IND meetings) update-your-member-lab-compendium-data to learn more about how to enter your lab’s information into the Laboratory Compendium. Limitations of the COA Compendium include, but are not limited to: This is irrespective of whether the disease, condition, indication, claim, or COA is included in the COA Compendium.ĭrug sponsors are strongly encouraged to check the repository of guidance documents for the most current disease specific FDA guidances, which may contain additional information related to COA selection. The inclusion of a COA in the COA Compendium does not equate to an endorsement by FDA and does not represent agency guidance.ĭrug sponsors are strongly encouraged to seek advice from the relevant Office of New Drug (OND) review division early in drug development to discuss the selection and implementation of COAs specific to their program. It is the hypothetical source of/evidence for its existence is provided by: Latin pendere "to hang, to cause to hang," pondus "weight" (perhaps the notion is the weight of a thing measured by how much it stretches a cord), pensare "to weigh, consider " Greek ponos "toil," ponein "to toil " Lithuanian spendžiu, spęsti "lay a snare " Old Church Slavonic peti "stretch, strain," pato "fetter," pina "I span " Old English spinnan "to spin," spannan "to join, fasten stretch, span " Armenian henum "I weave " Greek patos "garment," literally "that which is spun " Lithuanian pinu "I plait, braid," spandau "I spin " Middle Welsh cy-ffiniden "spider " Old English spinnan "draw out and twist fibers into thread," spiðra "spider," literally "spinner.The Clinical Outcome Assessment (COA) Compendium is a communication tool and it is intended to serve as a starting point when considering a COA for use in clinical trials. It forms all or part of: append appendix avoirdupois compendium compensate compensation counterpoise depend dispense equipoise expend expense expensive hydroponics impend painter (n.2) "rope or chain that holds an anchor to a ship's side " pansy penchant pend pendant pendentive pending pendular pendulous pendulum pension pensive penthouse perpendicular peso poise ponder ponderous pound (n.1) "measure of weight " prepend prepense preponderate propensity recompense span (n.1) "distance between two objects " span (n.2) "two animals driven together " spangle spanner spend spider spin spindle spinner spinster stipend suspend suspension. ![]() Proto-Indo-European root meaning "to draw, stretch, spin." ![]()
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