Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The informa-tion on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale,application procedure, and maintenance. Results: FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion Each expedited program requiresa different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innova-tive medication development.

Purpose: Patients experience severe physical trauma every year. However, studies on survivors’ experiences after severe injury are limited. Previous studies have mainly focused on time spans of trauma treatment. This study aimed to comprehensively explore survivors’ experiences to improve the current quality of trauma treatment and highlight the importance of patient-centered care. Materials and Methods: Structured, face-to-face interviews with six domains were conducted on survivors aged ≥18 years who were previously hospitalized in an intensive care unit due to traumatic injuries. Self-reported questionnaires were administered for a multidimensional assessment of participants’ conditions. Transcripts of each narrative were analyzed per grounded theory. Results: Fourteen participants were assessed. The median injury severity score was 25.5. The median elapsed time from injury to interview was 17.3 months. The physical and psychiatric difficulties of the participants remained unresolved even after completing rehabilitation. The main theme derived from the narratives were struggle with injury, consequences, and contributing factors, with the following subthemes: 1) suffering from injury and treatment, 2) psychological adaptation to the changed self and life after the accident, 3) significant family support, 4) gratitude to medical staff despite inadequacies in the healthcare system, and 5) legal and economic issues that impede recovery. Conclusion Increased efforts focusing on enabling survivors of severe injury to return to society and improve their quality of life are needed, including the establishment of patient-centered care in the trauma field, extended care for the survivors’ families, multidisciplinary treatment, and the collection of quantitative post-discharge data.

Purpose: Patients experience severe physical trauma every year. However, studies on survivors’ experiences after severe injury are limited. Previous studies have mainly focused on time spans of trauma treatment. This study aimed to comprehensively explore survivors’ experiences to improve the current quality of trauma treatment and highlight the importance of patient-centered care. Materials and Methods: Structured, face-to-face interviews with six domains were conducted on survivors aged ≥18 years who were previously hospitalized in an intensive care unit due to traumatic injuries. Self-reported questionnaires were administered for a multidimensional assessment of participants’ conditions. Transcripts of each narrative were analyzed per grounded theory. Results: Fourteen participants were assessed. The median injury severity score was 25.5. The median elapsed time from injury to interview was 17.3 months. The physical and psychiatric difficulties of the participants remained unresolved even after completing rehabilitation. The main theme derived from the narratives were struggle with injury, consequences, and contributing factors, with the following subthemes: 1) suffering from injury and treatment, 2) psychological adaptation to the changed self and life after the accident, 3) significant family support, 4) gratitude to medical staff despite inadequacies in the healthcare system, and 5) legal and economic issues that impede recovery. Conclusion Increased efforts focusing on enabling survivors of severe injury to return to society and improve their quality of life are needed, including the establishment of patient-centered care in the trauma field, extended care for the survivors’ families, multidisciplinary treatment, and the collection of quantitative post-discharge data.

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The informa-tion on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale,application procedure, and maintenance. Results: FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion Each expedited program requiresa different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innova-tive medication development.

Purpose: Patients experience severe physical trauma every year. However, studies on survivors’ experiences after severe injury are limited. Previous studies have mainly focused on time spans of trauma treatment. This study aimed to comprehensively explore survivors’ experiences to improve the current quality of trauma treatment and highlight the importance of patient-centered care. Materials and Methods: Structured, face-to-face interviews with six domains were conducted on survivors aged ≥18 years who were previously hospitalized in an intensive care unit due to traumatic injuries. Self-reported questionnaires were administered for a multidimensional assessment of participants’ conditions. Transcripts of each narrative were analyzed per grounded theory. Results: Fourteen participants were assessed. The median injury severity score was 25.5. The median elapsed time from injury to interview was 17.3 months. The physical and psychiatric difficulties of the participants remained unresolved even after completing rehabilitation. The main theme derived from the narratives were struggle with injury, consequences, and contributing factors, with the following subthemes: 1) suffering from injury and treatment, 2) psychological adaptation to the changed self and life after the accident, 3) significant family support, 4) gratitude to medical staff despite inadequacies in the healthcare system, and 5) legal and economic issues that impede recovery. Conclusion Increased efforts focusing on enabling survivors of severe injury to return to society and improve their quality of life are needed, including the establishment of patient-centered care in the trauma field, extended care for the survivors’ families, multidisciplinary treatment, and the collection of quantitative post-discharge data.

Purpose: Patients experience severe physical trauma every year. However, studies on survivors’ experiences after severe injury are limited. Previous studies have mainly focused on time spans of trauma treatment. This study aimed to comprehensively explore survivors’ experiences to improve the current quality of trauma treatment and highlight the importance of patient-centered care. Materials and Methods: Structured, face-to-face interviews with six domains were conducted on survivors aged ≥18 years who were previously hospitalized in an intensive care unit due to traumatic injuries. Self-reported questionnaires were administered for a multidimensional assessment of participants’ conditions. Transcripts of each narrative were analyzed per grounded theory. Results: Fourteen participants were assessed. The median injury severity score was 25.5. The median elapsed time from injury to interview was 17.3 months. The physical and psychiatric difficulties of the participants remained unresolved even after completing rehabilitation. The main theme derived from the narratives were struggle with injury, consequences, and contributing factors, with the following subthemes: 1) suffering from injury and treatment, 2) psychological adaptation to the changed self and life after the accident, 3) significant family support, 4) gratitude to medical staff despite inadequacies in the healthcare system, and 5) legal and economic issues that impede recovery. Conclusion Increased efforts focusing on enabling survivors of severe injury to return to society and improve their quality of life are needed, including the establishment of patient-centered care in the trauma field, extended care for the survivors’ families, multidisciplinary treatment, and the collection of quantitative post-discharge data.

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The informa-tion on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale,application procedure, and maintenance. Results: FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion Each expedited program requiresa different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innova-tive medication development.

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The informa-tion on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale,application procedure, and maintenance. Results: FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion Each expedited program requiresa different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innova-tive medication development.

Purpose: Patients experience severe physical trauma every year. However, studies on survivors’ experiences after severe injury are limited. Previous studies have mainly focused on time spans of trauma treatment. This study aimed to comprehensively explore survivors’ experiences to improve the current quality of trauma treatment and highlight the importance of patient-centered care. Materials and Methods: Structured, face-to-face interviews with six domains were conducted on survivors aged ≥18 years who were previously hospitalized in an intensive care unit due to traumatic injuries. Self-reported questionnaires were administered for a multidimensional assessment of participants’ conditions. Transcripts of each narrative were analyzed per grounded theory. Results: Fourteen participants were assessed. The median injury severity score was 25.5. The median elapsed time from injury to interview was 17.3 months. The physical and psychiatric difficulties of the participants remained unresolved even after completing rehabilitation. The main theme derived from the narratives were struggle with injury, consequences, and contributing factors, with the following subthemes: 1) suffering from injury and treatment, 2) psychological adaptation to the changed self and life after the accident, 3) significant family support, 4) gratitude to medical staff despite inadequacies in the healthcare system, and 5) legal and economic issues that impede recovery. Conclusion Increased efforts focusing on enabling survivors of severe injury to return to society and improve their quality of life are needed, including the establishment of patient-centered care in the trauma field, extended care for the survivors’ families, multidisciplinary treatment, and the collection of quantitative post-discharge data.

Objectives: . The recent expansion of eligibility for cochlear implantation (CI) by the U.S. Food and Drug Administration (FDA) to include infants as young as 9 months has reignited debates concerning the clinically appropriate cut-off age for pediatric CI. Our study compared the early postoperative trajectories of receptive and expressive language development in children who received CI before 9 months of age with those who received it between 9 and 12 months. This study involved a unique pediatric cohort with documented etiology, where the timing of CI was based on objective criteria and efforts were made to minimize the influence of parental socioeconomic status. Methods: . A retrospective review of 98 pediatric implantees recruited at a tertiary referral center was conducted. The timing of CI was based on auditory and language criteria focused on the extent of delay corresponding to the bottom 1st percentile of language development among age-matched controls, with patients categorized into very early (CI at <9 months), early (CI at 9–12 months) and delayed (CI at 12–18 months) CI groups. Postoperative receptive/expressive language development was assessed using the Sequenced Language Scale for Infants receptive and expressive standardized scores and percentiles. Results: . Only the very early CI group showed significant improvements in receptive language starting at 3 months post-CI, aligning with normal-hearing peers by 9 months and maintaining this level until age 2 years. During this period (<2 years), all improvements were more pronounced in receptive language than in expressive language. Conclusion . CI before 9 months of age significantly improved receptive language development compared to later CI, with improvements sustained at least up to the age of 2. This study supports the consideration of earlier CI, beyond pediatric Food and Drug Administration labeling criteria (>9 months), in children with profound deafness who have a clear deafness etiology and language development delays (<1st percentile).