Approval Criteria Research Articles

Food Products with High Antioxidant and Antimicrobial Activities and Their Sensory Appreciation

(1) Background: The demand for healthy and nutritious food is growing worldwide. Fermented dairy products are highly valued by consumers for their health benefits. Kefir is a fermented dairy product that brings many benefits to the consumer due to its antioxidant, anticancer, antidiabetic, antihypertensive and antimicrobial properties. Extracts from various plants in the form of volatile oils have a beneficial efct on consumer health. Following the research, their antioxidant and antimicrobial activities were demonstrated. (2) Methods: In the present study, the main purpose was to obtain a fermented dairy product with a high nutritional value; therefore, kefir, enriched with three types of volatile oils, namely, volatile mint oil, volatile fennel oil and volatile lavender oil, was made. The kefir samples obtained were sensory and texturally analyzed. The beneficial effect on health must also be studied in terms of the acceptability of these products by consumers from a sensory point of view. A non-numerical method based on several multi-personal approval criteria was used to interpret the results obtained in the sensory analysis. In the textural analysis, the consistency, cohesiveness and firmness of the kefir samples were analyzed. (3) Results: The samples enriched with volatile oils obtained superior results compared to the control sample in both conducted examinations. Kefir samples with volatile oils retained their sensory and textural characteristics for a longer time during storage. (4) Conclusions: The volatile oils added to kefir positively influenced the sensory and textural characteristics of the finished product.

Exploring the Relationship between Project Selection and Approval Criteria and Infrastructure Sustainability

This research aimed at compiling project selection criteria and modelling a robust criterion for infrastructure project selection and approval to enhance sustainability. The decision to select and approve sustainable infrastructure project for development must base on a robust criterion. To handle this properly, first, decision-makers must adopt a robust criterion that aid infrastructure sustainability. The study employed a systematic literature review, methodology and thematic analysis procedure to identify infrastructure project selection and approval criteria from literature. A total of 34 project selection criteria were identified and grouped into five categories. Besides, four approval requirements and four sustainable indicators have been discussed. To avoid any ambiguous and unclear questions in the criterion, 40 professionals were selected purposively for the pilot survey. Descriptive and inferential statistical analyses were employed, and findings were used to improve the criteria. The quantitative phase of the study was conducted on 320 stakeholders who were either project selectors, approvers, advisors, or designers responsible for government projects. S.E.M. were adopted for the analysis and testing of the hypothesis. Moreover, the study has proposed a structure model that integrates identified criteria and indicators to enhance infrastructure selection and approval. Continuous professional development training is vital for all stakeholders to understand and adopt the proposed project selection and approval criteria model to improve infrastructure sustainability performance and to enhance project selection and approval practices. And it was also included in the design brief as a deliverable factor. This outcome serves as preliminary and exploratory research to aid further study on the project selection and approval criteria model for infrastructure sustainability.]

Heart Transplant System of Korea

The Korean Ministry of Drug and Food Safety approved the clinical use of durable left ventricular assist devices (LVADs) in 2014. However, Korean Health Insurance and Assessment service had not covered durable LVADs until October 2018[1]. Implantation of durable LVADS has increased from 31 for 7 years before insurance coverable to 230 for 40 months after insurance coverage. The criteria for insurance coverage are quite distinct which requires both institutional heart transplantation experience and approval for each case before surgery. The popularization of durable LVADs resulted in changing main bridge therapy from extracorporeal membrane oxygenation (ECMO) to durable LVADs in most centers. However, a few hospitals which do not meet institutional approval criteria still use ECMO as a bridge therapy. Waiting list mortality, post-transplant survival, and cost-effectiveness of durable LVADs in Korea are under evaluation by academic society. The Korean Ministry of Drug and Food Safety approved the clinical use of durable left ventricular assist devices (LVADs) in 2014. However, Korean Health Insurance and Assessment service had not covered durable LVADs until October 2018[1]. Implantation of durable LVADS has increased from 31 for 7 years before insurance coverable to 230 for 40 months after insurance coverage. The criteria for insurance coverage are quite distinct which requires both institutional heart transplantation experience and approval for each case before surgery. The popularization of durable LVADs resulted in changing main bridge therapy from extracorporeal membrane oxygenation (ECMO) to durable LVADs in most centers. However, a few hospitals which do not meet institutional approval criteria still use ECMO as a bridge therapy. Waiting list mortality, post-transplant survival, and cost-effectiveness of durable LVADs in Korea are under evaluation by academic society.

How Does Monetary Policy Uncertainty Influence Firms’ Dynamic Adjustment of Capital Structure

This study employs high-dimensional factors model to depict the development of monetary policy uncertainty (MPU) in China over the past decades and develops a logical analytical framework to analyze the effect of MPU on the dynamic adjustment of a firm’s capital structure through bank risk-taking channels. We investigate how MPU affects dynamic adjustment of a firm’s capital structure using a panel data set of China public manufacturers between 2007 and 2018 and find that the higher the MPU, the more detrimental it is to the dynamic adjustment of firm’s capital structure. Further, bank risk-taking plays the role of a financial stabilizer. In addition to the willingness to take risks in on-balance sheet operations and the scale of loans, the risk-taking of our banks may also be reflected in the adjustment of the off-balance-sheet shadow banking scale. This study also finds that in terms of on-balance sheet business, heighten MPU decreases the scale of bank credit and tightens loan approval criteria, in terms of off-balance sheet business, heighten MPU decreases the scale of shadow banking, thereby leading to a lower dynamic adjustment of firm’s capital structure. JEL classification C13, C36, E50, G21

Development and implementation of a national online application system for cross-jurisdictional linked data.

The Population Health Research Network (PHRN) is an Australian national data linkage infrastructure that links a wide range of health and human services data in privacy-preserving ways. The data linkage infrastructure enables researchers to apply for access to routinely collected, linked, administrative data from the six states and two territories which make up the Commonwealth of Australia, as well as data collected by the Australian Government. The PHRN is a distributed network where data is collected and managed at the respective jurisdictional and/or cross-jurisdictional levels. As a result, access to linked data from multiple jurisdictions requires complex approval processes. This paper describes Australia's approach to enabling access to linked data from multiple jurisdictions. It covers the identification of, and agreement to, a minimum set of data items to be included in a unified national application form, the development and implementation of a national online application system and the harmonisation of business processes for cross-jurisdictional research projects. Utilisation of the online application system and the ongoing challenges of data linkage across jurisdictions are discussed. Changes to the data custodian and ethics committee approval criteria were out of scope for this project.

Technical Considerations for Development of Policy and Approvals for In-Water Cleaning of Ship Biofouling

Submerged ship surfaces are often inhabited by diverse sessile and sedentary marine organisms, which can directly impact vessel operations and increase the likelihood of non-indigenous species (NIS) establishment and impacts. Ship in-water cleaning (IWC) systems are now being incorporated into biofouling policy, and rigorous, transparent, and predictive verification testing is vital to regulatory success. Performance criteria for IWC approval should focus on environmental protection goals by including: qualified and independent testing; quantitative, robust, and statistically sound data, rather than qualitative observations; water sampling at all critical control points to characterize the release of harmful materials, including dissolved and particulate biocides; measurable and protective endpoints, rather than percent reductions; determinations of presence or absence of macro-organisms, irrespective of species origins or physiological state; and appropriately trained IWC operators.

1019. Clinical Impact of a Rapid Cerebrospinal Fluid Diagnostic Stewardship Program for Suspected Central Nervous System Infections in Children

BackgroundDespite widespread use, the optimal implementation and clinical impact of FilmArray Meningitis Encephalitis Panel (MEP; Table 1) multiplex PCR testing of cerebrospinal fluid (CSF) in children with suspected (CNS) infections is unknown.Table 1: FilmArray Meningitis Encephalitis Panel Test Characteristics MethodsA pre-post quasi-experimental cohort study to investigate the impact of implementing MEP using a rapid CSF diagnostic stewardship program was conducted at Children’s Hospital Colorado (CHCO). MEP was implemented with EMR indication selection to guide testing to children meeting approved use criteria: i. infants < 2mo, ii. immunocompromised, iii. encephalitis, iv. > 5 WBCs in CSF. Positive results were communicated with antimicrobial stewardship real-time decision support (Fig 1). All cases with CSF obtained by lumbar puncture (LP) sent to the CHCO microbiology laboratory meeting any of the 4 criteria above were included with pre-implementation controls (2015-2016) compared to post-implementation cases (2017-2018). Primary outcome was time-to-optimal antimicrobials (time from LP to 1st dose of antimicrobials targeted to identified pathogen, or cessation when no treatable pathogen identified).Figure 1: Rapid Cerebrospinal Fluid Diagnostic Stewardship Program Intervention Design ResultsPost-implementation (n=1127) and pre-implementation (n=1124) group characteristics are in Table 2. Following implementation, MEP was sent in 72% of cases, largely replacing pathogen-specific singleplex CSF testing (Table 3). Time-to-optimal antimicrobials decreased by 10 hours (p< 0.0001; Fig 2). There were no differences in time-to-effective antimicrobials, hospital admissions, antimicrobial starts or length of stay. Time-to-positive CSF results was faster (4.8 vs. 9.6 hrs, p< 0.0001), IV antimicrobial duration was shorter (24 vs 36 hrs, p=0.004) with infectious neurologic diagnoses more frequently identified (15% vs. 10%, p=0.03). Overall, 3% had bacterial and 9% viral CNS infection identified. Enterovirus (n=128) was most common, then HSV (n=28) and parechovirus (n=17) with similar detection rates between groups ConclusionImplementation of MEP with a rapid CNS diagnostic stewardship program improved antimicrobial use with faster results shortening empiric therapy. Routine MEP testing in high-yield cases rapidly detects common viral causes and rules out bacterial targets to enable antimicrobial optimizationDisclosures Samuel R. Dominguez, MD, PhD, BioFire Diagnostics (Consultant, Research Grant or Support)DiaSorin Molecular (Consultant)Pfizer (Grant/Research Support) Samuel R. Dominguez, MD, PhD, BioFire (Individual(s) Involved: Self): Consultant, Research Grant or Support; DiaSorin Molecular (Individual(s) Involved: Self): Consultant; Pfizer (Individual(s) Involved: Self): Grant/Research Support

Real-World Applicability of Commercial Chimeric Antigen Receptor T Cell Therapy Among Older Adults with Relapsed and/or Refractory Multiple Myeloma

Introduction: In 2021, the US FDA approved idecabtagene vicleucel, the first Chimeric Antigen Receptor-T cell (CAR-T) therapy for patients with relapsed/refractory multiple myeloma (MM) who had received at least four prior lines of therapy. Approval was based on phase II KARMMA trial of this drug showing a response rate of 73% and median progression free survival of 8.8 months; efficacy parameters considered transformative in this setting. Other CAR-T cell therapies are being tested in similar population. However, it is unknown what proportion of real world MM patients, particularly older adults, would be eligible for this treatment.Methods: We used the Flatiron Health Electronic Health Record (EHR) derived de-identified database to select patients newly diagnosed with MM from January 2011 to December 2016. We limited our cohort to those who received ≥1 line of myeloma treatment within 90 days of diagnosis. Lines of therapy (LoT) were ascertained using Flatiron oncologist-defined rules based on the addition of new anti-myeloma agents and gap periods during which no treatment was received. All patients were followed up to the initiation of fifth-line therapy, death or their last structured visit, whichever came earlier. We computed the cumulative incidence of initiating LoT therapy with death prior to fifth-line as the competing risk, remaining patients were censored at their last structured activity in the EHR. For patients initiating fifth LoT, we assessed their CAR-T eligibility using the following key inclusion criteria per the KARMMA trial (ECOG 0-1, GFR >45 ml/min, ANC > 1250 /mm3, Platelet >75k/mm3, ALT/AST <2.5 x upper limit, Bilirubin <2x upper limit, and active treatment for secondary cancer) extracting relevant variables within 90 days of the start of fifth line therapy. Differences in cumulative incidence rates were compared using univariate Fine-Gray's test. All p-values were two sided and the level of significance was 0.05.Results: A total of 4522 eligible patients were identified. The cohort was representative of population of MM patients and patterns of MM therapy in the US with a median age at diagnosis of 69 y (IQR 61-77) and 49% with age 70y or older, 54% males, and 63% non-Hispanic whites. Overall, 20% had ISS III disease, with 11% high risk cytogenetics 31% receiving initial therapy with proteasome inhibitor and immunomodulatory-based triplet therapy and 28% receiving stem cell transplant. In the overall cohort, the cumulative incidence of starting fifth LoT 8y from diagnosis was 28%, while the cumulative risk of death before initiating 5 th LoT was 53% (Figure). However, achievement of 5 th line therapy at 8y was much lower for older adults (35% for age<70y vs 20% for age ≥70y; p value <0.01, Figure), while the risk of death before achieving 5 th line therapy was higher among older patients (37% for age<70y vs 69% for age≥70y; p value <0.01). Among the patients reaching 5 th line therapy, only 44% would be eligible for CAR-T therapy based on the aforementioned eligibility criteria, which translates to about 8.9% of all newly diagnosed older adults ≥70y.Conclusion: Less than 10% of newly diagnosed older adults with MM are expected to be eligible for CAR-T therapy based on the current FDA approval and eligibility criteria. Meanwhile a much higher proportion of patients die before reaching CAR-T eligibility. These findings highlight the need to explore CAR-T cell therapy in earlier lines of disease and in a population that better represents real world patients to expand the applicability of this novel treatment. [Display omitted] DisclosuresGiri: CareVive: Honoraria, Research Funding; PackHealth: Research Funding. Costa: BMS: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Karyopharm: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria, Speakers Bureau; Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau.

Annals for Educators - November 2021.

Annals for Educators - November 2021.

U.S. Food and Drug Administration Reasoning in Approval Decisions When Efficacy Evidence Is Borderline, 2013-2018.

The U.S. Food and Drug Administration (FDA) has substantial flexibility in its approval criteria in the context of life-threatening disease and unmet therapeutic need. To understand the FDA's evidentiary standards when flexible criteria are employed. Case series. Applications submitted between 2013 and 2018 that went through multiple review cycles because the evidence for clinical efficacy was initially deemed insufficient. Information was obtained from the approval package (available on Drugs@FDA), including advisory committee minutes, FDA reviews, and complete response letters. Of 912 applications reviewed, 117 went through multiple review cycles; only 22 of these faced additional review primarily because of issues related to clinical efficacy. Concerns about the end point, the clinical meaningfulness of the observed effect, and inconsistent results were common bases for initial rejection. In 7 of the 22 cases, the approval did not require new evidence but rather new interpretations of the original evidence. No FDA decisions cited reasoning used in previous decisions. The conclusions rely on the authors' interpretation of the FDA statements and on a series of "close calls." The FDA has no mechanism to find or tradition to cite similar cases when weighing evidence for approvals, resulting in standalone, bespoke decisions. These decisions show highly variable criteria for "substantial evidence" when flexible evidential criteria are used, highlighted by the recent approval of aducanumab. A precedential tradition and suitable information system are required for the FDA to improve institutional memory and build upon past decisions. These would increase the FDA's decisional transparency, consistency, and predictability, which are critical to preserving the FDA's most valuable asset, the public's trust. U.S. Food and Drug Administration.

Synthesis and Evaluation of Local De-emulsifiers with Field Assessment in Iraqi Oil Fields

De-emulsifiers are one of the important industrial additives used commonly in petroleum industry in order to separate the salt water from crude oil essential the wet crude oil fields in south oil company (B.O.C) in Iraqi fields. De-emulsifiers activities due to the ability of these additives for breaking the thin film between dispersed phase and continuous phase globules in order to obtain two immiscible phase via the adsorption mechanism of the surfactants. In the present study has prepared local demulsifies by synthesis Gemini surfactants bis (Quaternary ammonium salt). The local de-emulsifier was assess in the laboratories of South Oil Company (B.O.C) Comparison with the results of commercial de-emulsifier (A), where the local material efficiency was higher than the important commercial (A) adopted in the B.O.C by bottle Test and later was produced (26) barrels of material prepared and evaluated in AL-SHAMIA Degassing station in Iraqi South Rumaila in (B.O.C). Where, evaluated the local de-emulsifier in the fields and show the positive results, this describes the evaluation of field emulsifying the local material in this study with lost cost of preparation of a one barrel about 500$ in the time that the cost of one barrel of commercial de-emulsifier is 1000$. The assessment was in the conditions of commercial de-emulsifier, depending on the natural of Dehydrator and Desalter in addition of the effective Dose is 25ppm and by 100% separation efficiency in same fresh oil source. The efficiency of local de-emulsifier studied Varity of parameters like: Temperature and the time required to separation function of the Dose. The field evaluation conditions of local de-emulsifier were under control outside of the oils (fresh) of D2 (Desalter) of isolation units to examine all of the water and salt content of crude oil. This was prepared for export according to the approved evaluation criteria compared with the commercial de-emulsifier imported and used in the oil sector.

An open science pathway for drug marketing authorization-Registered drug approval.

Florian Naudet and co-authors propose a pathway involving registered criteria for evaluation and approval of new drugs.

Certification nationale pour la chirurgie des cancers gynécologiques

In France, we are lacking an identified pathway for training in gynaecological cancer surgery. The four competent French learned societies: the SFOG, the CNGOF, the SFCO and the SCGP supported by the CNU of Obstetrics & Gynaecology, and UNICANCER agreed to materialize this course and attest it by a certification awarded by a national jury. The national committee of certification in gynaecological oncology made up of ten members, representing the 6 concerned organizations, set itself five objectives: the definition of the eligibility criteria for training centres; the determination of a check-list to be filled by the candidate; the determination of a targeted curriculum for the training in gynecological oncological surgery; the determination of the assets necessary for the certification of a candidate already in practice; and the practical organization of the certification. Criteria for approval of centres for training included 150 gynaecological cancer cases per year, among which 100 excisional surgeries, including twenty advanced-stage ovarian cancers. For certification of candidate who followed the curriculum established by the committee or by validation of prior experience for an actual practitioner, a candidate must validate a logbook and fill out a checklist including four parts: theoretical and practical training; research and publications; teaching and subscription to a continuing education program. The accomplished elements of the logbook and the checklist will be evaluated by a score. The first certification session is planned for the end of 2021.

Role of cefditoren in the treatment of community skin and soft tissue infections: revisiting the evidence

RESUMENCefditoreno pivoxilo es una cefalosporina oral de tercera generación de espectro ampliado con eficacia frente a gram-negativos, grampositivos y algunos anaerobios, incluyendo a aquellos microorganismos más frecuentes causantes de infecciones de piel y tejidos blandos (IPTB). Pese a que todavía no se dispone de puntos de corte de sensibilidad, multitud de estudios farmacocinéticos y farmacodinámicos reafirman el uso de cefditoreno para las IPTB. En pacientes con IPTB, incluyendo aquellas causadas por Staphylococcus aureus y Streptococcus pyogenes, cefditoreno ha demostrado tasas elevadas de curación clínica tras compararse con otras cefalosporinas orales.

Improving the Quality and Performance of Institutional Review Boards in the U.S.A. Through Performance Measurements.

Performance measurement leads to quality improvement, because performance measurement can identify areas of vulnerability to guide quality improvement activities. Recommendations from empirical institutional review board (IRB) performance measurement data on research approval criteria, expedited review protocols, exempt protocols, and IRB continuing review requirements published over the past 10 years are reviewed here to improve the quality and efficiency of IRBs. Implementation of these recommendations should result in improvements that can be evaluated by follow-up performance measurements.

Investigating Green Hospital Criteria Using Delphi Method for Fars Province, Southwest of Iran, 2019

Introduction: Designing and constructing hospitals using green approach, renewable resources reduce energy consumption and carbon emissions, and improve environmental air quality. The purpose of the present study was to determine Green hospital's criteria in Fars province, Southwest of Iran, 2019. Methods: In the Qualitative study, first, the criteria were identified systematically. Then, the criteria for establishing a green hospital were determined by content analysis and software methods. Then, for localization, using the Delphi method, the effective criteria for establishing a green hospital in Fars province were selected. Thirty experts in the field were selected using purposive sampling. Excel 2016 software was used for analysis. This study was a mixed-method study that was conducted from 2018 to the first half of the year 2019. At first, the criteria were identified by the systematic review method, and then the data extraction was analyzed using the content method. Finally, the criteria identified by the questionnaire were provided to 30 health experts. Experts were selected by purposeful sampling. In the present study, Excel 2016 software was used for analysis. Results: Green Hospital's criteria were 72 criteria out of 21 common angles in the systematic review stage. In Fars province, 34 criteria in 13 dimensions of site stability, construction stage (architecture), environmental quality, management, resources, bio purchase, Experts selected energy efficiency, water, wastewater, waste and waste recycling, transportation, healthcare, and innovation. The most important aspects for Fars province are the management costs. Conclusion: The approved criteria for Fars province, as well as other valid models in the field of the green hospital, management, water efficiency, and energy, were approved. In general, the reasons for choosing approved dimensions can be due to the various models emphasizing these dimensions and the relevance of dimensions to hospitals' challenges.

Quality, efficacy, safety-it is not enough!

There is a need of comparative studies to understand the differences in term of efficacy and safety of drugs with different mechanisms of action but similar therapeutic indications. This requires changes in the European Legislation of criteria for drug approval.

Out-of-programme experience in UK neurosurgery trainees: optimising the transition back into clinical practice

INTRODUCTION Out of programme (OOP) experience from training increases the skill pool of the neurosurgical workforce and drives innovation in the specialty. OOP approval criteria are well defined but transition back to clinical work can be challenging with a paucity of data published on trainee perspectives. Our study aimed to investigate factors influencing transition from OOP back to clinical work among neurosurgical trainees in the UK. METHODS An online survey was sent to all members of the Society of British Neurological Surgeons. Questions pertained to details of OOP and factors influencing transition back to clinical work. RESULTS Among the 73 respondents, 7 were currently on OOP and 27 had completed OOP in the past. Research was the most common reason for OOP (28/34, 82%) and this was generally motivated by the aspiration of an academic neurosurgery career (17/34, 50%). Although the majority (27/34, 79%) continued clinical work during OOP, 37% of this group (10/27) reported a reduction in their surgical skills. Fewer than half (15/34, 44%) had a return to work plan, of which only half (8/34, 24%) were formal plans. The majority of respondents who had completed OOP in the past (22/27, 81%) felt that they were able to apply the skills gained during OOP to their clinical work on return. CONCLUSIONS Skills learnt during OOP are relevant and transferable to the clinical environment but mainly limited to research with OOP for management and education underrepresented. Deterioration of surgical skills is a concern. However, recognition of this problem has prompted new methods and schemes to address challenges faced on return to work.

Beall's legacy in the battle against predatory publishers

AbstractBetween 2009 and 2012, Jeffrey Beall published four articles which analysed 18 publishers (17 of which he identified as predatory). He also introduced the term predatory in the context of scientific publishing. In 2012, he started Beall's List, which maintained a list of predatory publishers and journals. This became a valuable resource for those who wanted to know if a journal was legitimate, although others were very critical of the list. This article considers what he wrote and the list he developed and the criticisms that have been levelled against Beall's list. Beall's legacy can be considered to ensure that the problems of fraudulent or inappropriate publishing practices are highlighted and that the scientific community remains aware of the problem. Unfortunately, his legacy has not led to an eradication of predatory journals, and the problem appears to have become worse in the past decade. Although there is opportunity to build on his legacy, there have been few practical moves, and this article suggests that there is an opportunity for clearer, more universally accepted guidelines and approval criteria for quality journals.

Could have tethered: predicting the proportion of scoliosis patients most appropriate for thoracic anterior spinal tethering.

Posterior spinal fusion (PSF) has proven to be a safe, reliable technique to treat spinal deformities in adolescents. In recent early reports, vertebral body tethering (VBT) is showing promise as a method to modulate growth, driving scoliosis correction, while offering the potential added benefit of maintaining some flexibility in the instrumented segment. With recent FDA humanitarian device exemption (HDE) approval, VBT is poised to become more widely available as a treatment for a subset of current PSF candidates. Our aim was to use approved criteria from a recent FDA IDE to determine who could have been tethered in the years preceding approval. A retrospective analysis was performed of patients with idiopathic scoliosis treated with PSF or VBT at a large pediatric spine center from 1/1/2016 to 6/25/2019. Tethering indications followed the criteria outlined by an ongoing FDA IDE: age 8-16, Sanders bone age ≤ 4, primary thoracic curve between 35° and 60°, and lumbar curve < 35°. Risser sign and triradiate cartilage status were also employed to ascertain skeletal maturity in the absence of Sanders score. Of the 359 patients (78.6% female) who underwent PSF or VBT for idiopathic scoliosis, 75 (20.9%) met IDE criteria for VBT (57 had PSF and 18 had VBT). 284 were not appropriate for thoracic VBT: 77 (21.4%) had a non-thoracic primary curve, 80 (22.3%) were too mature at presentation, 36 (10.0%) had a lumbar curve > 34°, 9 (2.5%) had a main thoracic curve out of range, and 1 had a proximal thoracic curve > 40°. 81 patients (22.6%) had multiple exclusionary criteria. After decades with a successful treatment for AIS (PSF), we are at an inflection point: VBT is conditionally approved by the FDA as an HDE device, unleashing more widespread use. Many pediatric spine surgeons will want to know what proportion of PSFs will someday be VBTs. If FDA IDE criteria are used to ensure that a VBT candidate has an appropriate maturity stage and scoliosis deformity pattern, 20.9% of our 359 surgical range patients would have qualified for thoracic VBT. Level III.