In early 2007, President Bush issued Executive Order 13,422, extending executive review to significant guidance documents, requiring the designation of a politically-appointed Regulatory Policy Officer (RPO) within each agency, and strengthening the review and consultation role of the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA). Almost simultaneously, the OMB issued its Final Bulletin for Good Guidance Practices (GGP) to address the growing agency practice of using non-binding guidance documents in lieu of rulemaking procedures to direct the conduct of regulated entities. This paper describes the evolution of executive review of rulemaking and guidance, the impetus for the current changes, and the possible implications of the executive order and OMB's Final Bulletin on Good Guidance Practices for the health law arena.
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Res Social Adm Pharm
January 2025
Laboratory of Teaching and Research in Social Pharmacy (LEPFS), Department of Pharmacy, Federal University of Sergipe, Cidade Universitária "Prof. José Aloísio Campos", Jardim Rosa Elze, São Cristóvão, SE, CEP: 49100- 000, Brazil. Electronic address:
Background: Worldwide, hospitals are responsible for restoring health. However, poorly executed processes in these institutions can lead to risks and harm to patients, especially in identifying drug related problems. This fact justifies the proposal of tools to support the diagnosis, management and resolution of these problems.
View Article and Find Full Text PDFBMC Health Serv Res
January 2025
Department of Health Policy and Management, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Background: Family physician program is one of the effective reforms of the health system in Iran, but despite the implementation of this program in rural areas and the passage of ten years since its implementation in two provinces of Fars and Mazandaran, its implementation has faced problems. The aim of this study is to identify and prioritize implementation solutions related to the challenges of the family physician program in Iran.
Methods: This is a qualitative study using semi-structured interviews with 22 snowball-sampled experts and managers of basic health insurers to extract problems and executive solutions through coding and data analysis using Atlas Ti software and content analysis in the first stage.
Lancet Neurol
February 2025
Department of Clinical Neurological Sciences, University of Western Ontario, London, ON, Canada; Department of Cognitive Neurology, St Joseph's Health Care London, London, ON, Canada. Electronic address:
Background: No treatments exist for apathy in people with frontotemporal dementia. Previously, in a randomised double-blind, placebo-controlled, dose-finding study, intranasal oxytocin administration in people with frontotemporal dementia improved apathy ratings on the Neuropsychiatric Inventory over 1 week and, in a randomised, double-blind, placebo-controlled, crossover study, a single dose of 72 IU oxytocin increased blood-oxygen-level-dependent signal in limbic brain regions. We aimed to determine whether longer treatment with oxytocin improves apathy in people with frontotemporal dementia.
View Article and Find Full Text PDFPharmaceuticals (Basel)
January 2025
Department of Drug Form Technology, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, Poland.
Introduction: The official implementation of pharmaceutical-grade cannabis raw materials for medicinal use has permitted doctors to prescribe and pharmacists to prepare cannabis-based formulations. The objective of the pharmaceutical development and manufacturing process optimization work was to propose a suppository formulation containing doses of 25 mg and 50 mg of tetra-hydrocannabinol (∆-9-THC) as an alternative to existing inhalable or orally administered formulations. The formulation could be used for rectal or vaginal administration, thereby providing dosage control in the treatment of endometriosis and other conditions involving pain.
View Article and Find Full Text PDFCommun Biol
January 2025
Sony Computer Science Laboratories Inc. (Sony CSL), Tokyo, Japan.
Complex motor skills involve intricate sequences of movements that require precise temporal coordination across multiple body parts, posing challenges to mastery based on perceived error or reward. One approach that has been widely used is to decompose such skills into simpler, constituent movement elements during the learning process, thereby aligning the task complexity with the learners' capacity for accurate execution. Despite common belief and prevalent adoption, the effectiveness of this method remains elusive.
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