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Objective: Identify disease categories in which single-item global impression (GI) scales were included in product labeling of new drugs approved by the US Food and Drug Administration (FDA) in January 2009-December 2019 and review the characteristics of GIs included in product labeling of new FDA-approved drugs (January 2017-December 2019).Methods: FDA Clinical Outcome Assessment (COA) Compendium was reviewed for drug labels that included GIs for drugs approved in 2009-2016. The indication, year of approval, ICD-10 code, and GI respondent were noted. A manual review of labels of FDA-approved drugs (2017-2019) was undertaken to identify GIs included in the labels. Corresponding drug approval packages were reviewed to identify details of any regulatory reviewer comments related to GIs. GI characteristics were noted from the drug label or the review documents, including the respondent, type of measure (static or dynamic), item wording, concept assessed, and response options.Results: Product labeling containing GIs was most common in diseases related to the skin, nervous system, behavioral disorders, and the musculoskeletal system. GIs were included in 30/77 (39.0%) drug labels in the four disease categories.Conclusion: In the past 10 years, GIs have been included as endpoint measures in confirmatory clinical trials and have generated evidence of treatment benefit in diseases related to the skin, nervous system, behavioral disorders, and the musculoskeletal system. GIs frequently provide important insights into the patient experience. Before GIs are included in clinical trials to assess treatment benefit, it is important to ensure that they are valid, reliable, and responsive. [ABSTRACT FROM AUTHOR]

Alien or non-native species are defined as species living outside their natural distributional ranges. The spread of alien species is increasing globally as a result of rapid technological advances and globalization. Recent investigations have estimated global hotspots of alien established species on the basis of geopolitical boundaries, including Dawson et al. (in: Nat Ecol Evol 1:186. 10.1038/s41559-017-0186, 2017). In particular, these investigations do not consider Intra-Country Established Alien Species, i.e., successful introductions that occur among regions within the same country. In continental countries such as Brazil, the USA and China, studies excluding Intra-Country Established Alien Species (IEAS) waste essential information. Here, we argue that researchers should also consider intra-country introductions when estimating and addressing the risks of alien introductions. By using detailed data for freshwater fish including IEAS in large countries, we demonstrate that novel hotspots for IEAS have arisen worldwide. We illustrate emblematic examples of IEAS, as well as their vectors and negative impacts, to demonstrate the range of impacts that might be missed when excluding IEAS data from analysis. We recognize the need for generalizations, but generalizations based on incomplete data can misinform conservation efforts, particularly in megadiverse regions. Ignores IEAS influences how we count non-native species, invasions and perceive invisibility and impacts. Consequently, upcoming records and analysis of invasion patterns and management of aliens and EAS global hotspots must account for such biases in quantifying the IEAS portion. [ABSTRACT FROM AUTHOR]