A wide range of fluorescent dyes and reagents exist for labeling organelles in live and fixed cells. Choosing between them can lead to confusion, and optimization for many of them can be challenging. Presented here is a discussion on the commercially available reagents that have shown the most promise for each organelle of interest, including endoplasmic reticulum/nuclear membrane, Golgi apparatus, mitochondria, nucleoli, and nuclei, with an emphasis on localization of these structures for microscopy. Included is a featured reagent for each structure with a recommended protocol, troubleshooting guide, and example image. © 2023 Wiley Periodicals LLC. Basic Protocol 1: Endoplasmic reticulum and nuclear membrane labeling using ER-Tracker reagents Basic Protocol 2: Labeling Golgi apparatus using dye-labeled ceramides Basic Protocol 3: Labeling mitochondria using MitoTracker Red CMXRos Basic Protocol 4: Labeling nucleoli using SYTO RNASelect Green.

Toddler milk is an ultra-processed beverage consisting primarily of powdered milk, caloric sweeteners, and vegetable oil. Pediatric health authorities do not support the use of toddler milk, and emerging evidence suggests that toddler-milk marketing practices may mislead consumers. However, studies have not synthesized the extent of toddler-milk marketing practices or how these practices affect parents\' decisions about whether to serve toddler milk. We aimed to summarize the literature about toddler milk to identify what is known about: (1) parents\' toddler-milk purchasing and feeding behaviors, (2) toddler-milk marketing, and (3) how marketing practices influence parents\' beliefs and perceptions about toddler milk. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR), we systematically searched 8 databases (PubMed, APA PsycINFO, Scopus, Cochrane Central, Embase, CINAHL, Communication & Mass Media Complete, and Business Source Premier). We identified 45 articles about toddler milk. Studies were conducted in 25 countries across 6 continents. Five types of findings emerged: (1) consumption and feeding behaviors, (2) demographic correlates of toddler-milk purchasing and consumption, (3) misperceptions and beliefs, (4) increased sales, and (5) increased marketing and responses to marketing. The included articles suggested that toddler-milk sales are growing rapidly worldwide. Findings also revealed that toddler-milk packages (eg, labels, branding) resemble infant formula packages and that toddler-milk marketing practices may indirectly advertise infant formula. Purchasing, serving, and consumption of toddler milk were higher in Black and Hispanic populations than in non-Hispanic White populations, and parents with higher educational attainment and income were more likely to offer toddler milk to their children. Findings suggest a need for policies to prevent cross-marketing of toddler milk and infant formula, reduce provision of toddler milk to infants and toddlers, and prevent caregivers from being misled about toddler-milk healthfulness.

UNASSIGNED: Despite wide use of PRO tools in clinical development, resulting data is rarely incorporated into the US label. This study reviewed oncology product labels approved by the Food and Drug Administration (FDA) between 2006 and 2020 to determine if the number of PRO included in labeling has meaningfully changed. Sponsors were assessed to identify demographic trends in achieving PRO label success.
UNASSIGNED: FDA-approved drugs were searched utilizing the Drugs@FDA database by month from January 2015 to December 2020 for novel drug and biologic approvals. Products approved between 2006-2014 were identified utilizing the Gnansakthy et al., 2012 and 2016 publications. Labels were reviewed for inclusion of PRO data in the label and product summary basis of approval (SBA). Sponsor size and experience were measured for each year of product approval.
UNASSIGNED: 155 oncology products received initial approval between 2006-2020, of which only 7 contained PRO data in the label. More than half (53.5%) of products had PRO data described in the SBA. Over time, PRO information has increasingly been included in the product marketing application. Sponsors utilizing PRO data tend to be experienced in oncology development and larger in size.
UNASSIGNED: There has been a small increase in inclusion of PRO data in oncology product labeling over the past 15 years. Utilization and analysis of appropriate PRO tools and data remains a challenge to sponsors. Further collaboration with FDA is needed for the development of disease specific PRO tools that provide meaningful data to the targeted patient population.

The common fluorescent conjugated materials present weak or quenching luminescent phenomena in the solid or aggregate state (ACQ), which limits their applications in medicine and biology. In the last two decades, certain materials, named aggregation-induced emission (AIE) fluorescent materials, have exhibited strong luminescent properties in the aggregate state, which can overcome the ACQ phenomenon. Due to their intrinsic properties, the AIE materials have been successfully used in biolabeling, where they can not only detect the species of ions and their concentrations in organisms, but can also monitor the organisms\' physiological activity. In addition, these kinds of materials often present non-biological toxicity. Thus, AIE materials have become some of the most popular biofluorescent probe materials and are attracting more and more attention. This field is still in its early infancy, and several open challenges urgently need to be addressed, such as the materials\' biocompatibility, metabolism, and so on. Designing a high-performance AIE material for biofluorescent probes is still challenging. In this review, based on the molecular design concept, various AIE materials with functional groups in the biofluorescent probes are introduced, including tetrastyrene materials, distilbene anthracene materials, triphenylamine materials, and hexaphenylsilole materials. In addition, according to the molecular system design strategy, the donor-acceptor (D-A) system and hydrogen-bonding AIE materials used as biofluorescent probes are reviewed. Finally, the biofluorescent probe design concept and potential evolution trends are discussed. The final goal is to outline a theoretical scaffold for the design of high-performance AIE biofluorescent probes that can at the same time further the development of the applications of AIE-based biofluorescent probes.

A review of new oncology indications approved by the European Medicines Agency (EMA) for 2012-2016 showed that 33% of new drugs had labeling based on patient-reported outcomes (PROs). We reviewed labeling text based on PRO endpoints for new oncology indications approved during 2017-2021.
New oncology drugs approved by EMA to treat indications of cancers during 2017-2021 were identified from the EMA website. PRO-related language reported in EMA summaries of product characteristics (SmPCs) were summarized and compared with similar findings reported for oncology indications approved during 2012-2016.
Review documents by the EMA during 2017-2021 were available for 49 new oncology drugs for 70 cancer indications. Submissions for 52 (74.3%) of the 70 indications included PRO data for EMA review. Of all submissions, 14 (20.0%) approvals contained PRO-related language in the SmPC. Broad concepts such as health-related quality of life were most common and found in 8 of 14 (57.1%) PRO-related labels.
PRO-related language appeared in SmPCs for 20% of all indications of new oncology drugs approved by EMA during 2017-2021 compared with approximately 33% of EMA approvals during 2012-2016. PRO-related labeling during the same periods showed a greater decline (from 47% to 27%) for indications of new oncology drugs that also included PRO data. One possible reason for this decline may be the increase in open-label studies from 62% between 2012 and 2016 to approximately 79% between 2017 and 2021.

The global market for plant-based products is increasing at a faster rate than the market for traditional dairy products. Current regulations provide standards for those traditional dairy products but lack the same regulations for similar plant-based products. Resulting from this difference in regulation is consumer confusion over the differences between the 2 types of products. The purpose of this review paper was to understand how the differences between traditional dairy and plant-based dairy-like products could affect litigation by consumer and dairy manufacturers against potential misleading labeling. A review of the available literature found 4 relevant articles for analysis. Consumers and manufacturers can pursue claims against potentially misleading product labeling but must provide sufficient evidence to prove deception or injury. Past litigation against plant-based products for being misleading has ruled in favor of the plant-based defendants. These rulings were based on the notion that reasonable consumers would not be misled. Consumer and manufacturing advocates for dairy products should focus more resources on the education of consumers rather than litigation if the goal is to promote dairy products. Long-term regulatory changes could be made through the Defending Against Imitations and Replacements of Yogurt, Milk, and Cheese to Promote Regular Intake of Dairy Everyday Act, which is currently under legislative review.

The 1990s saw rapid growth in international activity in hematopoietic cell transplantation. As national donor registries were established and international collaboration increased, a need to transfer cellular therapy products across national borders emerged. A lack of international standards for identification, terminology and labeling resulted in significant challenges for import and export. Twenty years of effort by a large group of experts supported by professional societies and accreditation bodies has today achieved a high degree of standardization. This review highlights the main landmarks in this journey and serves as a reminder of the importance of taking the \"long view\" when working toward international standardization. It demonstrates the need for continual maintenance and enhancement of standards to meet the changing needs of the cell therapy industry and highlights recent developments in ISBT 128.

Growing concern regarding non-biodegradable plastics and the impact of these materials on the environment has promoted interest in biodegradable plastics. The intensification of separate biowastes collection in most European countries has also contributed to the development of biodegradable plastics, and the subject of their end-of-life is becoming a key issue. To date, there has been relatively little research to evaluate the biodegradability of biodegradable plastics by anaerobic digestion (AD) compared to industrial and home composting. However, anaerobic digestion is a particularly promising strategy for treating biodegradable organic wastes in the context of circular waste management. This critical review aims to provide an in-depth update of anaerobic digestion of biodegradable plastics by providing a summary of the literature regarding process performance, parameters affecting biodegradability, the microorganisms involved, and some of the strategies (e.g., pretreatment, additives, and inoculum acclimation) used to enhance the degradation rate of biodegradable plastics. In addition, a critical section is dedicated to suggestions and recommendations for the development of biodegradable plastics sector and their treatment in anaerobic digestion.

Nonpriority legume allergies, which include chickpea, pea, lentil, and lupine, are frequently implicated in severe allergic reactions. Yet, studies on public health knowledge and educational needs are near-absent.
To summarize what is known from the existing literature about nonpriority legume food allergy.
Eligible, original research articles reported on both nonpriority legume food allergy and 1 or more of prevalence, burden, food labeling information, or current education strategies. Screening was performed by 2 independent reviewers. Conflicts were discussed and if consensus could not be reached, a third reviewer was consulted.
Of the 8976 titles identified, 47 were included subsequent to full-text screening. Most studies identified focused on prevalence, and were conducted in Europe, with additional studies from Asia, and North America. Although we defined burden quite broadly, few studies addressed the burden of nonpriority legume food allergens. Moreover, no studies addressed labeling or educational needs for these allergens.
Our review of the literature found current research focused on the prevalence of nonpriority legume allergy with significant gaps regarding burden, allergen labeling, and education strategies. To this end, further research on these aspects of nonpriority legume allergy is warranted.

A concern with the increasing use of prescription drugs during pregnancy is teratogenic risk. This risk is undetermined for most drugs approved in the United States (US) from 2000 to 2010. Acne and psoriasis are chronic diseases that typically occur during the child-bearing years, and as topical retinoids are recommended for both acne and psoriasis treatment, is it possible for women to be exposed to a topical retinoid during pregnancy. Pharmacokinetic studies show relatively low systemic exposure from topical retinoids, but the exposure levels that could lead to teratogenicity in humans are unknown. Tazarotene, a topical retinoid, was US Food and Drug Administration (FDA) approved for both acne and psoriasis using pharmacokinetic data from psoriasis studies, which estimated the data based on use of tazarotene on up to 20% body surface area. As such, under both the previous and current FDA pregnancy labeling, tazarotene is not recommended for use during pregnancy. The goal of this literature review was to provide historical context for the pregnancy labeling rule for tazarotene compared with other approved retinoids and gather available data on tazarotene- and retinoid-related pregnancy outcomes. While there are case reports of topical tretinoin and adapalene exposure in utero, it is unclear if either affected fetal development. In terms of topical tazarotene, there are currently limited data regarding pregnancy outcomes after in-utero exposure. Additional case reports and outcomes studies are needed to further explore the safety of topical tazarotene in pregnancy.