scholarly journals US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised

2018 ◽  
Vol 142 (11) ◽  
pp. 1383-1387 ◽  
Author(s):  
Andrew J. Evans ◽  
Thomas W. Bauer ◽  
Marilyn M. Bui ◽  
Toby C. Cornish ◽  
Helena Duncan ◽  
...  
Keyword(s):  
United States ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Digital Pathology ◽  
The United States ◽  
Primary Diagnosis ◽  
Clinical Applications ◽  
Whole Slide Imaging ◽  
The Us ◽  
Available Information

April 12, 2017 marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology. Although this event is expected to facilitate more widespread adoption of whole slide imaging for clinical applications in the United States, it also raises a number of questions as to the means by which pathologists might choose to incorporate this technology into their clinical practice. This article from the College of American Pathologists Digital Pathology Committee reviews frequently asked questions on this topic and provides answers based on currently available information.

Allegron and aventyl - nortriptyline

1963 ◽  
Vol 1 (15) ◽  
pp. 57-58
Keyword(s):  
United States ◽  
Drug Administration ◽  
Wide Spectrum ◽  
Food And Drug Administration ◽  
The United States ◽  
Methyl Group ◽  
The Us ◽  
Drug Promotion ◽  
Depressant Drug

Nortriptyline, a new anti-depressant drug, has just been launched simultaneously as a “potent multi-phasic psychotrope, highly predictable in action” (Allegron - Dista), and as a “wide spectrum mood enhancer” (Aventyl - Lilly). Connoisseurs of drug promotion will note that Dista is a subsidiary of Lilly. Nortriptyline has not so far been marketed in the United States, where it was discovered; it has not yet been approved by the US Food and Drug Administration. Chemically the drug closely resembles amitriptyline, differing from it by only one methyl group.

scholarly journals Use of Flavored E-Cigarettes and the Type of E-Cigarette Devices Used among Adults and Youth in the US—Results from Wave 3 of the Population Assessment of Tobacco and Health Study (2015–2016)

2019 ◽  
Vol 16 (16) ◽  
pp. 2991 ◽  
Author(s):  
Liane M. Schneller ◽  
Maansi Bansal-Travers ◽  
Maciej L. Goniewicz ◽  
Scott McIntosh ◽  
Deborah Ossip ◽  
...  
Keyword(s):  
United States ◽  
Smoking Cessation ◽  
Drug Administration ◽  
Smoking Status ◽  
Food And Drug Administration ◽  
The United States ◽  
Health Study ◽  
Population Assessment ◽  
The Us

The United States (U.S.) Food and Drug Administration has expressed concern about flavored e-cigarettes (e.g., JUUL brand) because they are appealing to youth who may be unaware that the product is addictive. The Population Assessment of Tobacco and Health Study Wave 3 provided data on flavor categories, type of e-cigarette product, and smoking status among past 30-day youth and adult e-cigarette users in the US. Most past 30-day youth and adult users reported using only one flavor category, with fruit (53% youth, 31% adult) being the most commonly reported category. Adults were far more likely to report using tobacco flavor alone, compared to any other individual flavor category or flavor category combinations (OR: 21.08, 95%CI: 5.92, 75.12). Whereas, youth were more likely to report using multiple flavor categories (OR: 2.03, 95%CI: 1.55, 2.65), with the most reported pairing being fruit and candy (36%). The variety of flavors on the market appeals to consumers of all ages. Although most past 30-day e-cigarette users reported only one flavor category, non-tobacco flavors were far more common among youth. Differences in flavor preferences among adult versus youth vapers may have implications for the role of flavors in both the initiation of youth vaping and adult vaping for smoking cessation.

scholarly journals Low-Calorie Sweetened Beverages and Cardiometabolic Health: A Science Advisory From the American Heart Association

Circulation ◽  
2018 ◽  
Vol 138 (9) ◽  
Author(s):  
Rachel K. Johnson ◽  
Alice H. Lichtenstein ◽  
Cheryl A.M. Anderson ◽  
Jo Ann Carson ◽  
Jean-Pierre Després ◽  
...  
Keyword(s):  
United States ◽  
Drug Administration ◽  
High Intensity ◽  
Food And Drug Administration ◽  
The United States ◽  
Cardiometabolic Health ◽  
Low Calorie ◽  
Writing Group ◽  
Sweetened Beverages ◽  
The Us

In the United States, 32% of beverages consumed by adults and 19% of beverages consumed by children in 2007 to 2010 contained low-calorie sweeteners (LCSs). Among all foods and beverages containing LCSs, beverages represent the largest proportion of LCS consumption worldwide. The term LCS includes the 6 high-intensity sweeteners currently approved by the US Food and Drug Administration and 2 additional high-intensity sweeteners for which the US Food and Drug Administration has issued no objection letters. Because of a lack of data on specific LCSs, this advisory does not distinguish among these LCSs. Furthermore, the advisory does not address foods sweetened with LCSs. This advisory reviews evidence from observational studies and clinical trials assessing the cardiometabolic outcomes of LCS beverages. It summarizes the positions of government agencies and other health organizations on LCS beverages and identifies research needs on the effects of LCS beverages on energy balance and cardiometabolic health. The use of LCS beverages may be an effective strategy to help control energy intake and promote weight loss. Nonetheless, there is a dearth of evidence on the potential adverse effects of LCS beverages relative to potential benefits. On the basis of the available evidence, the writing group concluded that, at this time, it is prudent to advise against prolonged consumption of LCS beverages by children. (Although water is the optimal beverage choice, children with diabetes mellitus who consume a balanced diet and closely monitor their blood glucose may be able to prevent excessive glucose excursions by substituting LCS beverages for sugar-sweetened beverages [SSBs] when needed.) For adults who are habitually high consumers of SSBs, the writing group concluded that LCS beverages may be a useful replacement strategy to reduce intake of SSBs. This approach may be particularly helpful for persons who are habituated to a sweet-tasting beverage and for whom water, at least initially, is an undesirable option. Encouragingly, self-reported consumption of both SSBs and LCS beverages has been declining in the United States, suggesting that it is feasible to reduce SSB intake without necessarily substituting LCS beverages for SSBs. Thus, the use of other alternatives to SSBs, with a focus on water (plain, carbonated, and unsweetened flavored), should be encouraged.

scholarly journals Regulatory Considerations for Hemodiafiltration in the United States

2018 ◽  
Vol 13 (9) ◽  
pp. 1444-1449 ◽  
Author(s):  
Richard A. Ward ◽  
Jörg Vienken ◽  
Douglas M. Silverstein ◽  
Stephen Ash ◽  
Bernard Canaud
Keyword(s):  
United States ◽  
Drug Administration ◽  
Large Scale ◽  
Food And Drug Administration ◽  
The United States ◽  
Management Process ◽  
High Flux ◽  
Clinical Use ◽  
The Us ◽  
Testing Protocols

Online hemodiafiltration provides greater removal of higher molecular weight uremic retention solutes than conventional high-flux hemodialysis. However, online hemodiafiltration is used sparsely in the United States in part because of a paucity of delivery systems cleared for clinical use by the US Food and Drug Administration. Although a pathway for regulatory approval exists in the United States, concerns remain, particularly regarding online production of the large volumes of sterile, nonpyrogenic substitution fluid infused directly into the bloodstream to maintain fluid balance. Clearly defined testing protocols, acceptable to Food and Drug Administration, will be useful to show that an online hemodiafiltration system is capable of routinely achieving a sterility assurance level of 10−6 and nonpyrogenic levels of endotoxin. Large-scale clinical experience has shown that systems providing this level of performance when combined with certain design features, such as redundancy, and an appropriate quality management process can routinely and safely produce substitution fluid for online hemodiafiltration.

scholarly journals A Practical Guide to Whole Slide Imaging: A White Paper From the Digital Pathology Association

2018 ◽  
Vol 143 (2) ◽  
pp. 222-234 ◽  
Author(s):  
Mark D. Zarella ◽  
Douglas Bowman; ◽  
Famke Aeffner ◽  
Navid Farahani ◽  
Albert Xthona; ◽  
...  
Keyword(s):  
Practical Knowledge ◽  
Digital Pathology ◽  
Executive Leadership ◽  
The United States ◽  
White Paper ◽  
Primary Diagnosis ◽  
Basic Function ◽  
Whole Slide Imaging ◽  
Interinstitutional Collaboration ◽  
Glass Slides

Context.— Whole slide imaging (WSI) represents a paradigm shift in pathology, serving as a necessary first step for a wide array of digital tools to enter the field. Its basic function is to digitize glass slides, but its impact on pathology workflows, reproducibility, dissemination of educational material, expansion of service to underprivileged areas, and intrainstitutional and interinstitutional collaboration exemplifies a significant innovative movement with far-reaching effects. Although the benefits of WSI to pathology practices, academic centers, and research institutions are many, the complexities of implementation remain an obstacle to widespread adoption. In the wake of the first regulatory clearance of WSI for primary diagnosis in the United States, some barriers to adoption have fallen. Nevertheless, implementation of WSI remains a difficult prospect for many institutions, especially those with stakeholders unfamiliar with the technologies necessary to implement a system or who cannot effectively communicate to executive leadership and sponsors the benefits of a technology that may lack clear and immediate reimbursement opportunity. Objectives.— To present an overview of WSI technology—present and future—and to demonstrate several immediate applications of WSI that support pathology practice, medical education, research, and collaboration. Data Sources.— Peer-reviewed literature was reviewed by pathologists, scientists, and technologists who have practical knowledge of and experience with WSI. Conclusions.— Implementation of WSI is a multifaceted and inherently multidisciplinary endeavor requiring contributions from pathologists, technologists, and executive leadership. Improved understanding of the current challenges to implementation, as well as the benefits and successes of the technology, can help prospective users identify the best path for success.

Letters to the Editor

PEDIATRICS ◽  
1981 ◽  
Vol 68 (3) ◽  
pp. 473-473
Author(s):  
David B. Nelson ◽  
Renate D. Kimbrough ◽  
Philip S. Landrigan ◽  
A. Wallace Hayes ◽  
George C. Yang ◽  
...  
Keyword(s):  
United States ◽  
Drug Administration ◽  
Food Supply ◽  
Food Industry ◽  
The United States ◽  
Letters To The Editor ◽  
Department Of Agriculture ◽  
The Us ◽  
The World ◽  
Food Commodities

Dr Wray's comments are, of course, very appropriate and encouraging. Aflatoxin was first detected in food commodities from other parts of the world. As concentrations in other parts of the world have usually been higher, little attention has been paid to the possibility of aflatoxin exposure in humans in the United States except by those who are directly involved in monitoring the human food supply (US Department of Agriculture, the food industry, and the US Food and Drug Administration).

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