ABSTRACT
The U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science (DARS) moves new science into the drug review process and addresses emergent regulatory and public health questions for the Agency. By forming interdisciplinary teams, DARS conducts mission-critical research to provide answers to scientific questions and solutions to regulatory challenges. Staffed by experts across the translational research spectrum, DARS forms synergies by pulling together scientists and experts from diverse backgrounds to collaborate in tackling some of the most complex challenges facing FDA. This includes (but is not limited to) assessing the systemic absorption of sunscreens, evaluating whether certain drugs can convert to carcinogens in people, studying drug interactions with opioids, optimizing opioid antagonist dosing in community settings, removing barriers to biosimilar and generic drug development, and advancing therapeutic development for rare diseases. FDA tasks DARS with wide ranging issues that encompass regulatory science; DARS, in turn, helps the Agency solve these challenges. The impact of DARS research is felt by patients, the pharmaceutical industry, and fellow regulators. This article reviews applied research projects and initiatives led by DARS and conducts a deeper dive into select examples illustrating the impactful work of the Division.
ABSTRACT
Moving homes is a common experience for older adults in later life. Concomitant with moving is the transition process of adapting to the new home and developing a sense of place. When older adults change residences they experience disruption in place and risk losing identities. Leisure engagement has been known to help older adults adapt to new transitions in their life, such as death of a spouse, health decline and retirement. Leisure engagement has been linked to the development of sense of home and maintaining identity when moving to residential care settings and congregate living, however, these processes are not well understood. To date no literature has focused on the role of leisure in older adults moving to private dwellings. This study focused on the role of leisure in older adults moving to new homes in the context of London, Ontario. This study used an ethnographic approach involving interviews, activity diaries and mental maps. A total of 12 older adults participated in this study. Data were analyzed using holistic content and thematic analysis. The findings were divided into two integrated manuscripts, chapter 4, focusing on how leisure played a role in adapting to new homes during COVID-19 and chapter 5, which focused on negotiating place after moving homes. Chapter 4 describes how older adults used leisure to maintain identity and establish and maintain social connections after moving homes. Chapter 5 describes how the participants negotiated place using leisure differed for older adults who were single and older adults who were married. The findings also revealed that having shared characteristics with others and the tone of the social environment shaped the participants' leisure engagement after moving to London. Implications for this research include the need for practitioners and policymakers to establish leisure programs that recognize the factors affecting older adults in communities that could challenge their ability to establish a sense of place, such as experiencing a move along with other transitions, such as losing a spouse. The findings also have implications for city planners to develop social spaces for older adults to engage in leisure in their neighbourhoods. (PsycInfo Database Record (c) 2023 APA, all rights reserved)