Rigorous Approval Process Research Articles

Enhancing Animal Nutrition and Sustainability: The Vital Role of Genetically Modified Crops in Animal Feeding

Agriculture and livestock are fundamental to the economies of developing countries. A substantial portion of crop harvests is allocated for animal feed. Thus, more technological advancements are necessary to enhance agricultural productivity and provide affordable feed. Future biotech crops are expected to play a crucial role in this area. The goal is often to introduce traits into plants that do not naturally occur in these species. These new traits may include resistance to pests, diseases, or environmental conditions, or the production of specific nutrients or pharmaceutical agents. GM crops have indirectly benefited the livestock sector by increasing the yield of feed ingredients and improving quality traits. These crops are primarily used in livestock feed rations as energy and/or protein sources. Numerous animal feeding studies have been conducted to demonstrate that genetically modified crops are as nutritious and wholesome as compared to their conventional counterparts. No biological relevant differences in animal performance, health, or animal product (meat and milk) composition had been observed in various studies conducted. Overall, no significant differences in gain, intake, and feed conversion have been reported. Since the GM crop’s composition is not different from its conventional counterpart [except for the introduced transgene(s) and expressed protein(s)] and the expressed transgenic protein is rapidly digested in the digestive system, one would not expect any unintended effects. The introduction of genetically modified (GM) crops into the market undergoes extensive testing and a rigorous approval process to ensure food, feed, and environmental safety. This process includes thorough analyses before GM crops are deemed safe for commercial use. GM livestock feed is assessed for its nutritional composition and digestibility by comparing it with conventional crops. Therefore, while GM crops have the potential to enhance the efficiency of animal agriculture by improving nutritional content, reducing pesticide use, and increasing crop yields, it is essential to approach their adoption with caution.

Effective stewardship strategies to enhance appropriateness of refer-out test requests in a Canadian tertiary centre laboratory

ObjectivesSpecialized testing conducted in reference laboratories is costly and often not optimally directed. Since 2016, our institution has worked to ensure the appropriateness of refer-out (RO) tests. We examine the impact of utilization initiatives on the patterns of requests and completed tests. Design and methodsIn 2016, 81 RO tests were selected for a more rigorous approval process. Physicians not pre-approved for testing received a prompt to consult with laboratory subject matter experts (SMEs) for further detail. After review, SMEs provided responses, approving or rejecting requests based on clinical relevance. Stewardship activities also included: repatriating tests locally, preferring Canadian over foreign institutions, unbundling tests, distributing educational memos, and introducing staged testing. We collected data on the number of requested (NoR) and number of completed (NoC) tests in 2015, before the implementation of the new vetting procedures, and for the post-implementation phase from 2016−2022. ResultsFor 62 targeted RO tests (including trace metals, vitamins, antibodies, and endocrine-related tests), there was a 33% reduction in NoR and a 51% reduction in NoC in 2022 compared to 2015. The total savings for the study period based on NoC was $807,736. The NoC rate for Neuronal antibody tests decreased to 48.6% in 2022, with cost savings of $17,123, and an additional $50,000 saved by changing the testing site. Insourcing apolipoprotein B and fecal calprotectin tests resulted in cost savings of $3,380 and $3,371, respectively, in 2022. ConclusionsAutomated messaging followed by a formal review of RO test requests is an effective utilization strategy that prevents redundant or clinically unjustified testing. This approach leads to significant economic savings and is expected to improve the efficiency of patient care.

Blood glucose monitoring devices for type 1 diabetes: a journey from the food and drug administration approval to market availability.

Blood glucose monitoring constitutes a pivotal element in the clinical management of Type 1 diabetes (T1D), a globally escalating metabolic disorder. Continuous glucose monitoring (CGM) devices have demonstrated efficacy in optimizing glycemic control, mitigating adverse health outcomes, and augmenting the overall quality of life for individuals afflicted with T1D. Recent progress in the field encompasses the refinement of electrochemical sensors, which enhances the effectiveness of blood glucose monitoring. This progress empowers patients to assume greater control over their health, alleviating the burdens associated with their condition, and contributing to the overall alleviation of the healthcare system. The introduction of novel medical devices, whether derived from existing prototypes or originating as innovative creations, necessitates adherence to a rigorous approval process regulated by the Food and Drug Administration (FDA). Diverse device classifications, stratified by their associated risks, dictate distinct approval pathways, each characterized by varying timelines. This review underscores recent advancements in blood glucose monitoring devices primarily based on electrochemical sensors and elucidates their regulatory journey towards FDA approval. The advent of innovative, non-invasive blood glucose monitoring devices holds promise for maintaining stringent glycemic control, thereby preventing T1D-associated comorbidities, and extending the life expectancy of affected individuals.

Sharing Experiences in Selecting Clinical Outcome and Approving Validated Questionnaires : Insights from an Elderly Registry Study

Objectives: Underpinned by the context of a Korean traditional medicine cohort study on healthy aging, this research primarily aims to guide the selection of Clinical Outcome Assessments (COAs) for elderly healthy aging patient registry research, offering insights into the selection process; and secondly, to streamline the resource-intensive process of obtaining permissions for validated COAs, benefiting future traditional Korean medicine clinical researchers.Methods : In this study, we identified outcomes through a review of previous studies, followed by a process involving expert consultations to select the final outcomes. Subsequently, for the selected outcomes that were Clinical Outcome Assessments (COAs) developed tools, we searched in commercial databases to confirm the availability of Korean versions and the necessity of obtaining permissions. Finally, we obtained permissions for their utilization and, when needed, acquired the original instrument questionnaire through payment.Results: Through a literature review of existing observational studies, a total of 57 outcomes were selected, with 19 of them identified as COA instruments. Upon verifying usage permissions for these 19 instruments, it was found that 17 required author-specific permissions, and among these, 2 needed a purchase as they were commercially available.Conclusion: This study provides a detailed overview of outcome selection and permission acquisition for elderly patient registry research. It underscores the importance of Clinical Outcome Assessment (COA) tools and the rigorous approval process, aiming to enhance research reliability. Continuous verification of COA information is essential, and future research should explore Core Outcome Set (COS) development through consensus-building approaches like Delphi studies.

An exploration of simulation-based education from other health professionals, to create an informed and effective simulation delivery in a new diagnostic radiography programme

IntroductionThe recent validation of three Diagnostic Radiography programmes in the south of England involved a rigorous approval process with multiple Professional and Statutory Regulatory Bodies (PSRB's). Part of the validation process was evidencing that approximately 50% of each programme is spent undertaking practice-based learning. As well as clinical placements, practice-based learning includes simulation-based education (SBE). MethodologyFrom May 2022 to June 2022, a questionnaire was sent to all 22 simulation education facilitators from health courses belonging to the University School Simulation Group. Ethical approval was reviewed and approved by the Learning and Teaching Hub Research Ethics Panel. ResultsOf the initial 22 participants invited, the response rate was 59% (13 participants). The main themes arising from the analysis was the use of a theoretical or conceptual framework, a breakdown of the simulation session components and the role of simulation training. ConclusionThis questionnaire study demonstrated that there was a need for a standardised guide on how to deliver SBE. There is also a lack of feedback, training, and reassurance for facilitators. However, facilitators would welcome training or further training and HEE and the University have taken steps to prioritise SBE. Implications for practiceThe study highlighted how health professionals are delivering SBE within their subjects in innovative and creative ways. These ideas have helped to structure SBE within the new diagnostic radiography courses at the University.

Rating analysis and BERTopic modeling of consumer versus regulated mHealth app reviews in Germany

Germany introduced prescription-based mobile health (mHealth) apps in October 2020, becoming the first country to offer them fully reimbursed by health insurance. These regulated apps, known as DiGAs, undergo a rigorous approval process similar to pharmaceuticals, including data protection measures and sometimes clinical trials. This study compares the user experience of DiGAs with non-prescription mHealth apps in Germany, analyzing both average app store ratings and written reviews. Our study pioneers the use of BERTopic for sentiment analysis and topic modeling in the mHealth research domain. The dataset comprises 15 DiGAs and 50 comparable apps, totaling 17,588 German-language reviews. Results reveal that DiGAs receive higher contemporary ratings than non-regulated apps (Android: 3.82 vs. 3.77; iOS: 3.78 vs. 3.53; p < 0.01; non-parametric Mann–Whitney–Wilcoxon test). Key factors contributing to positive user experience with DiGAs are customer service and personalization (15%) and ease of use (13%). However, challenges for DiGAs include software bugs (24%) and a cumbersome registration process (20%). Negative user reviews highlight concerns about therapy effectiveness (11%). Excessive pricing is the main concern for the non-regulated group (27%). Data privacy and security receive limited attention from users (DiGAs: 0.5%; comparators: 2%). In conclusion, DiGAs are generally perceived positively based on ratings and sentiment analysis of reviews. However, addressing pricing concerns in the non-regulated mHealth sector is crucial. Integrating user experience evaluation into the review process could improve adherence and health outcomes.

Safety Messaging Boosts Parental Vaccination Intention for Children Ages 5-11.

The COVID-19 vaccination rate among children ages 5–11 is low in the U.S., with parental vaccine hesitancy being the primary cause. Current work suggests that safety and side effect concerns are the primary reasons for such vaccine hesitancy. This study explores whether this hesitancy can be mitigated with information interventions. Based on theories of health decision making and persuasion, we designed four information interventions with varying contents and lengths. We wrote two messages on vaccine safety (a detailed safety-long message and a succinct safety-short message), explaining the vaccine’s lower dosage, low rate of side effects, and the rigorous approval process. We also had two messages on protection effects (protect-family, protect-child). We combined these four messages with a vaccine-irrelevant control message and compared their effects on parental vaccine intention. We measured the parental vaccination intention using a 0–6 Likert scale question. Among the four intervention groups, we found that the short version of the safety message increased the average vaccination intention by over 1 point compared to the control arm, while the other three interventions failed to show significance. Specifically, these effects are particularly pronounced (around 2 points) for Republican parents who had a much lower initial intention to vaccinate their children. Our study highlights the importance of concise and to-the-point information rendering in promoting public health activities and therefore has important policy implications for raising vaccination intentions among parents, especially those leaning towards more conservative political affiliation.

E-Governance Systems: A Case Study of the Development of a Small-Scale Farmer Database

Use of enhanced Information Communication Technology is among the key targets set forth in the 7th National Development Plan. Absence of a rigorous approval process has seen an increase in the number of ghost farmers benefiting from the Farmer Input Support Programme. The lack of a single pool of farmer and marketing information for technocrats makes decision making a near impossible task. This paper proposes a system for the capturing and management of farmer information using cloud infrastructure. Having this information will bring efficiency to the activities of farmer-facing bodies such as the Farmer Input Support Programme and the Food Reserve Agency.

To See or NOsee: The Debate on the Nocebo Effect and Optimizing the Use of Biosimilars.

In addition to the general clinical benefit offered, biosimilars may not only generate savings for healthcare budgets but also improve patient access to biologic products. Since the first biosimilar was approved in Europe in 2006, a further 36 different biosimilar drugs have been approved for several indications. Despite the wealth of experience gained and the reported data supporting the use of biosimilars, both in naïve and biologic-experienced patients, some healthcare professionals continue to express doubt regarding the rigorous approval process for biosimilars and uncertainty with how to incorporate them into daily clinical practice. These opinions can be transferred to patients through poor or lack of communication, meaning that patients may lack confidence in treatment quality and, as a result, be susceptible to the nocebo effect. At the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting, during a debate the question was asked as to whether the nocebo effect was in fact being used to describe “any result you don’t agree with”. Here, we detail that the nocebo effect has been demonstrated in a number of clinical trials, and that this effect may negatively affect acceptance in patients switching from an originator product to a biosimilar. Awareness of the potential for the nocebo effect and adoption of enhanced communication techniques may be useful in mitigating the nocebo effect. Effective healthcare professional–patient dialogue is key in transferring confidence to the patient, and has been shown to reduce nocebo effects in patients when switching from an originator to a biosimilar.FundingBiogen International GmbH.

002 Simulated Over-the-counter use of Tamsulosin by Men with Urinary Symptoms

Lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) are common in men, however, many remain undertreated. Hence, self-management with over-the-counter (OTC) drugs is helpful. The FDA requires a rigorous approval process for prescription (Rx)-to-OTC switches. Currently, tamsulosin is being evaluated for OTC use in men with bothersome urinary symptoms. In a simulated OTC setting, we assessed the ability of men interested in a self-management option to appropriately follow instructions in a proposed Drug Facts Label (label). We conducted a 6-month, open-label, uncontrolled study of tamsulosin 0.4mg capsules in men who responded to advertisements on an OTC treatment for bothersome urinary symptoms. The label included product purpose, directions for use, and instructions on when to stop use/ask a doctor. Primary endpoint was compliance with “Stop use and ask a doctor if” directions, with 2 a priori performance thresholds (upper bound of 95%CI ≤10% or ≤5%). Secondary endpoint was behavior of men who reported a symptom/condition in the “Ask a doctor before use” section. Pre-mitigated responses comprised as-observed responses from men who failed to heed the “Stop use and ask a doctor if” instruction. These cases were reviewed and the decisions switched to ‘appropriate’ if deemed so by 2 of 3 urologists; post-mitigated (post) responses comprised urologist-reviewed responses.

Stem cells and respiratory disease

Stem cells and respiratory disease

Clinical experience with Zarzio® in Europe: what have we learned?

Biosimilars are similar, but non-identical, versions of existing biological drugs for which patents have expired. Despite the rigorous approval process for biosimilars, concerns have been expressed about the efficacy and safety of these products in clinical practice. Biosimilars of filgrastim, based on the originator product Neupogen®, have been available since 2008 and are now in widespread clinical use in Europe and elsewhere. Three biosimilar G-CSFs have been approved based on a combination of physicochemical and biological protein characterisation, pharmacokinetic and pharmacodynamic assessment in healthy volunteers and efficacy and safety data in patients with cancer. To assess whether biosimilars are effective in the real-world clinical practice setting, a pooled analysis of five post-approval studies of biosimilar G-CSF (Zarzio®) that included 1,302 adult patients who received at least one cycle of chemotherapy with G-CSF support for the prevention of neutropenia was conducted. A total of 36 % of patients had a febrile neutropenia risk of >20 %, while 39.6 % had a risk of 10–20 % based on chemotherapy regimen. The occurrence of severe or febrile neutropenia was within the range of that observed in previous studies of originator G-CSF. In addition, the safety profile of Zarzio® was consistent with that reported for originator G-CSF and the known safety profile of G-CSF. Initial concerns about the use of biosimilars, at least with regard to biosimilar G-CSFs, appear to be unfounded. Adoption of cost-effective biosimilars should help reduce healthcare costs and improve patient access to biological treatments.

The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation?

Medical devices, developed through physician and industry partnerships, have helped to revolutionize the treatment of disease spanning most medical disciplines. This includes such entities as deep brain stimulation implants for...

Nonnutritive Sweeteners: Where Are We Today?

Controversy continues to surround use of nonnutritive sweeteners among consumers, despite extensive premarket safety studies used in the rigorous approval process of the U.S. Food and Drug Administration (FDA). The American Diabetes Association and the National Cancer Institute hold positions that FDA-approved nonnutritive sweeteners may be safely used by consumers.1 However, people with diabetes also continue to question the use of nonnutritive sweeteners in a diabetes eating plan even with this assurance. Misinformation regarding nonnutritive sweeteners is shared routinely through multiple sources such as the Internet, print media, and electronic communications. As a result, diabetes educators and other health care professionals need to become more familiar with the safety and usage of these products to help people with diabetes discern fact from fiction. The potential benefits of nonnutritive sweeteners for people with diabetes are reductions in calories and carbohydrates for weight management and glycemic control, respectively, as well as reductions in the risk of tooth decay.2 This article reviews the history of nonnutritive sweeteners, explains FDA safety standards and definitions, and provides an overview of nonnutritive sweeteners available in the United States and practical teaching tips for counseling consumers about their use. Sweetening agents are broadly classified as nutritive sweeteners, which provide energy, and nonnutritive sweeteners, which provide little to no energy. Nonnutritive sweeteners are several hundred to several thousand times sweeter than sucrose. Although some actually provide calories, their intense sweetness means that they are used in such small amounts that they are generally considered noncaloric. Familiar nutritive sweeteners include sucrose, fructose, agave nectar, fruit juice, and honey. Each provides ~ 4 kcal/g. Nonnutritive sweeteners are different from sugar alcohols (also known as polyols) such as xylitol and sorbitol, which are considered nutritive sweeteners, providing an average of 2 kcal/g because of their incomplete digestion and absorption. …

Platform, Meet Apps: Pricing and Quality Under Cross-Sided Externalities

Our study is motivated by the observation that two-sided platforms often exercise control on access to and transactions on at least one side of the market. For example, Apple's rigorous approval process and recent policies that prohibit cross-platform app-building tools is an indication of imposing control on both access and quality of its app market. Extant literature on two-sided markets fails to accommodate platform’s interventions on participation by either side (i.e. consumers and sellers of complementary products) of the market because it typically focuses on a homogeneous population. Our work aims to bridge this gap and provides the underlying rationale for the platform firm’s governance structure and optimal pricing decisions.

Switching from Brand‐Name to Generic Psychotropic Medications: A Literature Review

Generic medications do not undergo the rigorous approval process required of original medications. Their effectiveness and safety is expected to be equal to that of their more expensive counterparts. However, several case reports and studies describe clinical deterioration and decreased tolerability with generic substitution. Pubmed was searched from January 1, 1974 to March 1, 2010. The MeSH term "generic, drugs" was combined with "anticonvulsants," "mood stabilizers," "lithium," "antidepressants," "antipsychotics," "anxiolytics," and "benzodiazepines." Additional articles were obtained by searching the bibliographies of relevant references. Articles in English, French, or Spanish were considered if they discussed clinical equivalence of generic and brand-name medications, generic substitution, or issues about effectiveness, tolerability, compliance, or economics encountered with generics. Clinical deterioration, adverse effects, and changes in pharmacokinetics are described with generic substitution of several anticonvulsants/mood stabilizers (carbamazepine, valproate, lamotrigine, gabapentin, topiramate, lithium), antidepressants (amitriptyline, nortriptyline, desipramine, fluoxetine, paroxetine, citalopram, sertraline, venlafaxine, mirtazapine, bupropion), antipsychotics (risperidone, clozapine), and anxiolytics (clonazepam, alprazolam). Generics do not always lead to the anticipated monetary savings and also raise compliance issues. Although the review is limited by publication bias and heterogeneity of the studies in the literature, we believe there is enough concern to advise generic switching on an individual basis with close monitoring throughout the transition. Health professionals should be aware of the stakes around generic substitution especially when health economics promote universal use of generics.