Usp Monograph Download
Irmela Caccavale
A monograph is a specialist written work (in contrast to reference works)[1] or exhibition on one subject or one aspect of a usually scholarly subject, often by a single author or artist. Although a monograph can be created by two or more individuals, its text remains a coherent whole and it keeps being an in-depth academic work that presents original research, analysis, and arguments. As a focused, in-depth and specialised written work in which one or more authors develop a uniform and continuous argument or analysis over the course of the book, a monograph is essentially different from an edited collection of articles. In an edited collection, a number of original and separate scholarly contributions by different authors are edited and compiled into one book by one or more academic editors.
In library cataloguing, monograph has a broader meaning: a non-serial publication complete in one volume (book) or a definite number of books. Thus it differs from a serial or periodical publication such as a magazine, academic journal, or newspaper.[2] In this context only, books such as novels are considered monographs.
The English term "monograph" is derived from modern Latin "monographia", which has its root in Greek.[3] In the English word, "mono-" means "single" and "-graph" means "something written".[4] Unlike a textbook, which surveys the state of knowledge in a field, the main purpose of a monograph is to present primary research and original scholarship. This research is presented at length, distinguishing a monograph from an article. For these reasons, publication of a monograph is commonly regarded as vital for career progression in many academic disciplines. Intended for other researchers and bought primarily by libraries, monographs are generally published as individual volumes in a short print run.[5]
In Britain and the U.S., what differentiates a scholarly monograph from an academic trade title varies by publisher, though generally it is the assumption that the readership has not only specialized or sophisticated knowledge but also professional interest in the subject of the work.[6]
In biological taxonomy, a monograph is a comprehensive treatment of a taxon. Monographs typically review all known species within a group, add any newly discovered species, and collect and synthesize available information on the ecological associations, geographic distributions, and morphological variations within the group.
In the context of Food and Drug Administration (FDA) regulation, monographs represent published standards by which the use of one or more substances is automatically authorized. For example, the following is an excerpt from the Federal Register: "The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products."[8] Such usage has given rise to the use of the word monograph as a verb, as in "this substance has been monographed by the FDA".
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act; P.L. 116-136) was signed into law. The CARES Act added section 505G to the Federal Food, Drug and Cosmetic (FD&C) Act. Section 505G reforms and modernizes the framework for the regulation of OTC monograph drugs.
OTC monograph drugs may be marketed without an approved drug application under section 505 of the FD&C Act if they meet the requirements of section 505G of the FD&C Act, including the OTC drug monograph (OTC monograph) and other applicable requirements.
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.
Under the process set forth in section 505G(b) of the FD&C Act, FDA has the authority to issue an administrative order (proposed and final) that adds, removes, or changes generally recognized as safe and effective (GRASE) conditions for an OTC drug monograph. Either FDA or a requestor can initiate the administrative order process.
The administrative order process to add, remove, or change a monograph can be initiated by either industry (any person or group of persons marketing, manufacturing, processing, or developing a drug) or FDA.
Industry can request that FDA issue an administrative order by submitting an OTC monograph order request (OMOR) to FDA. FDA will determine if the OMOR is acceptable for filing. If FDA accepts the OMOR for filing, FDA will the review the OMOR and issue a proposed order. The public will receive at least 45 calendar days to submit comments on the proposed order. After reviewing and considering the comments, FDA will issue a final order which is the final OTC monograph. All final orders are subject to dispute resolution, an administrative hearing, and judicial review.
FDA issues a proposed order. The public will receive at least 45 calendar days to submit comments on the proposed order. After reviewing and considering the comments, FDA will issue a final order which is the final OTC monograph. All final orders are subject to dispute resolution, an administrative hearing, and judicial review.
This monograph is an outcome of the Healthcare Leadership Initiative on Maintenance of Power, a project of ASHE and Powered for Patients aimed at furthering discussion around safeguarding emergency power for U.S. health care facilities. This monograph summarizes lessons learned from previous disasters, explains how to assess vulnerabilities, and suggests new ways to safeguard emergency power through new technologies, innovative protocols, and information sharing.
This is a list of Report on Carcinogens monographs (cancer health effects) and NTP monographs (noncancer health effects). You can search by type of monograph, and year published, with the "filter by type" and "filter by year" pulldown menus.
"This IAHR Water Monograph offers a comprehensive overview of the hydraulics of swirling flows commonly encountered in vortex dropshafts, reservoir intakes, and pump intakes. It encompasses significant advancements in our understanding of swirling flows over the past few decades, attributed to the progress in numerical modelling and laboratory measurement technology. The monograph provides valuable guidance for researchers, hydraulic modellers, and engineers engaged in studying and working with swirling flows and vortex intake design."
USP has embarked on a global initiative to modernize many of our existing monographs across all compendia. Having current monographs is tantamount to our mission of providing high-quality public standards. The links below provide information and resources related to our modernization efforts.
Monograph Modernization Web Meeting: The USP live web meeting on the monograph modernization initiative was held on February 25, 2011. There were over 100 participants representing about 70 organizations from the US and around the world. The meeting featured speakers from USP, FDA and CHPA and covered the following topics:
Call for Candidates: USP is issuing a call for candidates to serve on an Acetaminophen Expert Panel to be established by May 1, 2011. The members of the Panel will review, evaluate and generate proposals, procedures and data for the modernization of acetaminophen-containing dosage form monographs (e.g., tablets, capsules, oral solutions) and provide recommendations to the relevant Expert Committee(s).
USP received an October 12, 2010 letter from FDA emphasizing th importance of up-to-date monographs and encouraging USP to continue its monograph modernization efforts. A subsequent November 16, 2010 letter to USP from FDA listed USP monographs for acetaminophen and diphenhydramine and for several related dosage forms as high priority for FDA for updating. Most of these monographs assist in controlling the quality of over-the-counter (OTC) medications. The letter also identified as high priority NF monographs for copovidone, crospovidone, povidone and talc for updating. The October 12, 2010 and November 16, 2010 FDA letters and USP's November 23, 2010 and December 20, 2010 responses are available below.
To accomplish our mission we believe it is essential to change the way monograph publishing is funded. The reality is that university presses can no longer cover the costs of publishing specialized monographs through sales alone. Likewise, it is unreasonable to expect humanities and social sciences fields to adopt a STEM-style author-pays system. For these reasons, we believe that the only rational solution to the scholarly monograph dilemma is a system of institutionally funded faculty book subsidies that retains the same commitment to editorial excellence while guaranteeing global access through open access editions.
Peter Potter, ARL visiting program officer for TOME and director of publishing at Virginia Tech Publishing, and Sara Grimme, senior director of operations at Digital Science, consider the following question on the Digital Science Blog: What comes next for open access monographs as we cautiously start to envision life beyond COVID-19?
This monograph was originally published in 2013. While much of the content remains relevant, users should be aware that it has not been updated. The Joint Commission project staff is solely responsible for the content of this toolkit. This toolkit is informed by the research conducted by the project staff and the recommendations of our technical advisory panel. Published literature as well as information referred by project advisors, reviewers, and collaborating organizations was considered. However, toolkit project staff did not conduct a systematic literature review after the monograph was published. We hope this toolkit contains useful information, but it is not intended to be a comprehensive source for all relevant information. The Joint Commission and its collaborating organizations are not responsible for any claims or losses arising from the use of, or from any errors or omissions in this toolkit. The inclusion of any reference or example or of an organization name, product, or service in a Joint Commission publication should not be construed as an endorsement by The Joint Commission, or by the project technical advisory panel or any of its members, of any specific method, product, treatment, practice, program, service, vendor, or resource or of such organization, product, or service, nor is failure to include an organization name, product, or service to be construed as disapproval. 2013 The Joint Commission
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