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Project Orbis was initiated in May 2019 by the Oncology Center of Excellence to facilitate faster patient access to innovative cancer therapies by providing a framework for concurrent submissions and review of oncology products among international partners. Since its inception, Australia's Therapeutic Goods Administration (TGA), Canada's Health Canada (HC), Singapore's Health Sciences Authority (HSA), Switzerland's Swissmedic (SMC), Brazil's National Health Surveillance Agency (ANVISA), United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA), and most recently Israel's Ministry of Health (IMoH) Medical Technologies, Health Information, Innovation and Research (MTIIR) Directorate, have joined Project Orbis. While each country has its own expedited review pathways to bring promising therapies to patients, there are some similarities and differences in pathways and timelines. FDA's fast-track designation and MHRA's marketing authorization under exceptional circumstances (MAEC) allow non-clinical and limited clinical evidence to support approval under these programs. HC's Extraordinary Use New Drug (EUND) pathway allows granting exceptional use authorization with limited clinical evidence. ANVISA, HSA, MTIIR, and TGA do not have standard pathways that allow non-clinical evidence and limited clinical evidence. While there is no definite regulatory pathway for HSA, the current framework for approval does allow flexibility in the type of data (non-clinical or clinical) required to demonstrate the benefit–risk profile of a product. HSA may register a product if the agency is satisfied that the overall benefit outweighs the risk. All Project Orbis Partner (POP) countries have similar programs to the FDA accelerated approval program except ANVISA. Although HSA and MTIIR do not have defined pathways for accelerated approval programs, there are opportunities to request accelerated approval per these agencies. All POP countries have pathways like the FDA priority review except MHRA. Priority review timelines for new drugs range from 120 to 264 calendar days (cd). Standard review timelines for new drugs range from 180 to 365 cd. [ABSTRACT FROM AUTHOR]

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Introduction: Various obstacles to and facilitators of collaboration between an interdisciplinary work rehabilitation team and the stakeholders (workers, insurers, physicians, and employers) exist, but are not well characterized. Methods: An observational study was conducted, using videotapes of interdisciplinary team discussions of ongoing cases involving 22 workers absent from work due to musculoskeletal disorders. The actions taken and strategies adopted by the team in an effort to overcome the obstacles to collaboration were studied. Results: Various factors influence collaboration between the rehabilitation team and the stakeholders. In general, stakeholder endorsement of the team's therapeutic principles and confidence in their approach emerged as particularly important factors. Diverse strategies, most often, education and awareness-raising, were used by the team to foster collaboration among the parties. Conclusions: This study provides greater insight into the factors affecting collaboration among a rehabilitation team, an injured worker and other stakeholders. The results may improve understanding of the actions taken by rehabilitation teams and help to optimize their practices. [ABSTRACT FROM AUTHOR]