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The definitions of an academic monograph agree that it is generally a single-authored, scholarly contribution of professional research on a specific topic or aspect of a topic. What differentiates it from a journal article is largely length as it is considerably longer.
Scholarly monographs are single-volume works (books) providing in-depth research into a specialized area of knowledge. They contribute to the ongoing scholarship in a particular discipline by offering original insight into their subjects.
However, a major difference was acknowledged: unlike package inserts or medication guides that are reviewed and approved by the FDA, a pharmacy monograph patient information sheet is not reviewed or regulated by the FDA.
A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal, safe and effective use of the drug. Product monographs: Frequently asked questions - Canada.ca canada.ca services product-monograph canada.ca services product-monograph
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An OTC drug monograph establishes conditions, such as active ingredients, uses (indications), doses, routes of administration, labeling, and testing, under which an OTC drug in a given therapeutic category (e.g., sunscreen, antacid) is generally recognized as safe and effective (GRASE) for its intended use.

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