Therapeutic innovation & regulatory science最新文献_第4页

Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information. 测试数字医疗点解决方案的可行性，以实现新颖且信息丰富的不良事件信息的可信近实时双向交流。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2025-01-01 Epub Date: 2024-11-17 DOI: 10.1007/s43441-024-00711-9

Greg Powell, Vijay Kara, Daniel Naranjo, Mangesh Kulkarni, Kerri Best-Sule, Trinka Coster, Machaon Bonafede, Shruti Gangadhar, Lee Kallenbach, Andrew Bate

{"title":"Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information.","authors":"Greg Powell, Vijay Kara, Daniel Naranjo, Mangesh Kulkarni, Kerri Best-Sule, Trinka Coster, Machaon Bonafede, Shruti Gangadhar, Lee Kallenbach, Andrew Bate","doi":"10.1007/s43441-024-00711-9","DOIUrl":"10.1007/s43441-024-00711-9","url":null,"abstract":"A digital point-of-care solution was implemented to test the feasibility of near-real-time bi-directional communication between pharmacovigilance experts (PVEs) and healthcare professionals (HCPs) for exchanging unique and informative adverse event (AE) information. The solution was implemented in a commercially available electronic health record (EHR) system/platform, no direct contact between PVEs and the HCPs was possible. The Clinical Affairs team of the EHR vendor was used as an intermediary to ensure appropriate information was exchanged while protecting HCP and patient privacy. The study yielded 9 drug-event pairs of interest (AEI), 2 of which were confirmed as AEs by the HCP. On average it took 20.6 h to receive initial AEI information and 58.8 h to receive follow-up information, which represents a 96% reduction in time compared to current methods. Both interactions provided unique data that would not have been collected otherwise leading to the PVE being able to appropriately determine a potential causal association. This study successfully demonstrated the feasibility of using a compliant, bi-directional, digitally enabled clinical communication channel at the point of care to complement existing pharmacovigilance activities.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"124-134"},"PeriodicalIF":2.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706924/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142648745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of Borrowing Methods for Incorporating Historical Data in Single-Arm Phase II Clinical Trials. 单臂 II 期临床试验中纳入历史数据的借用方法比较。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2025-01-01 Epub Date: 2024-11-21 DOI: 10.1007/s43441-024-00723-5

Sara Urru, Michela Verbeni, Danila Azzolina, Ileana Baldi, Paola Berchialla

{"title":"Comparison of Borrowing Methods for Incorporating Historical Data in Single-Arm Phase II Clinical Trials.","authors":"Sara Urru, Michela Verbeni, Danila Azzolina, Ileana Baldi, Paola Berchialla","doi":"10.1007/s43441-024-00723-5","DOIUrl":"10.1007/s43441-024-00723-5","url":null,"abstract":"Background: Over the last few years, many efforts have been made to leverage historical information in clinical trials. Incorporating historical data into current trials allows for a more efficient design, smaller studies, or shorter duration and may potentially increase the relative amount of information on efficacy and safety. Despite these advantages, it is crucial to select external data sources appropriately to avoid introducing potential bias into the new study. This is where borrowing methods become useful. We illustrate and compare the latest methods of borrowing historical data in a single-arm phase II clinical trial setting, examining their impact on statistical power and type I error.Methods: We implemented static and dynamic versions of the power prior method, incorporating overlapping coefficient and loss functions and meta-analytic predictive priors. These methods were compared with standard and pooling approaches, in which none or all historical data are used.Results: Dynamic borrowing methods achieve lower type I error inflation than pooling. The power prior approach, integrated with overlapping coefficient, allowed for measuring the similarity of the subjects considering their baseline characteristics, thus the likelihood of the data contains information about both confounders and outcome. Using a discounting function to estimate the power parameter guarantees the similarity of historical information and current trial data.Conclusion: We provided a comprehensive overview of borrowing methods, encompassing frequentist and Bayesian approaches as well as static and dynamic technique, to guide researchers in selecting the most appropriate strategy.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"20-30"},"PeriodicalIF":2.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142688883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation - A Case Study of the DINAMO Trial. 用于儿科外推的药物计量学增强贝叶斯借法--DINAMO 试验案例研究。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2025-01-01 Epub Date: 2024-10-07 DOI: 10.1007/s43441-024-00707-5

Martin Oliver Sailer, Dietmar Neubacher, Curtis Johnston, James Rogers, Matthew Wiens, Alejandro Pérez-Pitarch, Igor Tartakovsky, Jan Marquard, Lori M Laffel

{"title":"Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation - A Case Study of the DINAMO Trial.","authors":"Martin Oliver Sailer, Dietmar Neubacher, Curtis Johnston, James Rogers, Matthew Wiens, Alejandro Pérez-Pitarch, Igor Tartakovsky, Jan Marquard, Lori M Laffel","doi":"10.1007/s43441-024-00707-5","DOIUrl":"10.1007/s43441-024-00707-5","url":null,"abstract":"Bayesian borrowing analyses have an important role in the design and analysis of pediatric trials. This paper describes use of a prespecified Pharmacometrics Enhanced Bayesian Borrowing (PEBB) analysis that was conducted to overcome an expectation for reduced statistical power in the pediatric DINAMO trial due to a greater than expected variability in the primary endpoint. The DINAMO trial assessed the efficacy and safety of an empagliflozin dosing regimen versus placebo and linagliptin versus placebo on glycemic control (change in HbA1c over 26 weeks) in young people with type 2 diabetes (T2D). Previously fitted pharmacokinetic and exposure-response models for empagliflozin and linagliptin based on available historical data in adult and pediatric patients with T2D were used to simulate participant data and derive the informative component of a Bayesian robust mixture prior distribution. External experts and representatives from the U.S. Food and Drug Administration provided recommendations to determine the effective sample size of the prior and the weight of the informative prior component. Separate exposure response-based Bayesian borrowing analyses for empagliflozin and linagliptin showed posterior mean and 95% credible intervals that were consistent with the trial results. Sensitivity analyses with a full range of alternative weights were also performed. The use of PEBB in this analysis combined advantages of mechanistic modeling of pharmacometric differences between adults and young people with T2D, with advantages of partial extrapolation through Bayesian dynamic borrowing. Our findings suggest that the described PEBB approach is a promising option to optimize the power for future pediatric trials.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"112-123"},"PeriodicalIF":2.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706882/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142381690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody Drugs. 新模式开发中的开放式创新和监管挑战：合同开发和制造组织在推动抗体药物发展中的关键作用。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2025-01-01 Epub Date: 2024-10-28 DOI: 10.1007/s43441-024-00701-x

Hiromu Yoshiura, Yayoi Kawata, Shintaro Sengoku

{"title":"Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody Drugs.","authors":"Hiromu Yoshiura, Yayoi Kawata, Shintaro Sengoku","doi":"10.1007/s43441-024-00701-x","DOIUrl":"10.1007/s43441-024-00701-x","url":null,"abstract":"Background: Ensuring regulatory-compliant manufacturing capability is an essential challenge for new treatment modalities, but its internalisation is not easy for pharmaceutical companies, especially start-ups. This study examines the functions and requirements of contracted development and manufacturing organisations (CDMOs) using the development process of antibody medicines as a case study.Methods: Utilizing PubMed, Cortellis and Patent Integration databases, this study delves into publication and contractual trends in monoclonal antibody drugs (mAbs) development, alongside an analysis of patent filings by CDMOs, offering a comprehensive overview of the evolving landscape in mAbs innovation.Results: In the early stages of mAbs development, dedicated bio firms (DBFs) led R&D with superior drug discovery technology but lacked manufacturing capability, which was complemented by CDMOs. This collaboration was an opportunity for CDMOs to expand their capabilities beyond manufacturing technology into antibody drug candidate discovery and structural optimisation technology. From mid-development onwards, it established a technology platform based on these capabilities and developed and established partnerships with existing pharmaceutical companies, including mega pharma.Conclusions: The impact of institutions and regulations on the innovation process was assessed during this development process. These findings are expected to provide valuable insights into the innovation system for new modalities.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"63-70"},"PeriodicalIF":2.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142523191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College Students. 超越Juul：未成年人尼古丁成瘾的新面孔——一项对大学生的调查。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-12-28 DOI: 10.1007/s43441-024-00735-1

Griffin Riggs, Terry David Church

{"title":"Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College Students.","authors":"Griffin Riggs, Terry David Church","doi":"10.1007/s43441-024-00735-1","DOIUrl":"https://doi.org/10.1007/s43441-024-00735-1","url":null,"abstract":"Background: Youth nicotine addiction is a major public health concern in the United States. Disposable Electronic Nicotine Delivery Systems (ENDS), or disposable vapes, are commonly sought out by youth despite not having received premarket authorization from the FDA. The objective of this study was to identify factors contributing to underage consumption of disposable ENDS.Methods: An anonymous survey was deployed to college students to understand young adults' perceptions and patterns of use of disposable ENDS.Results: Disposable ENDS are very popular among youth. The results of this study revealed the popular brands, flavors, modes of access, and attractive aspects of disposable ENDS. Survey results combined with information from the literature reveal that disposable ENDS gained popularity in the years following the decline in the popularity of pod-based ENDS, such as JUUL, following strict regulatory action from the FDA.Conclusion: To ultimately address underage nicotine addiction, the FDA must hold disposable ENDS to the same regulatory standards as other tobacco products and produce regulations specifically targeted at disposable ENDS. The results of this study emphasize the importance of making effective regulatory reform and functional educational resources to prevent young people from initiating the use of disposable ENDS.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142898308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Correction: A Global Industry Survey on Post-Approval Change Management and Use of Reliance. 更正：一项关于批准后变更管理和信赖使用的全球行业调查。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-12-28 DOI: 10.1007/s43441-024-00733-3

Andrew Deavin, Aliyah Hossain, Isabelle Colmagne-Poulard, Kum Cheun Wong, Mónica Perea-Vélez, Sonia Cappellini, Susanne Ausborn, Sylvie Meillerais, Céline Bourguignon

引用次数: 0

Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities. 赞比亚药品监管局监管审查程序的评估：挑战和机遇。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-12-27 DOI: 10.1007/s43441-024-00730-6

Constance Sakala Chisha, Makomani Siyanga, Stephanie Leigh, Adem Kermad, Stuart Walker

{"title":"Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities.","authors":"Constance Sakala Chisha, Makomani Siyanga, Stephanie Leigh, Adem Kermad, Stuart Walker","doi":"10.1007/s43441-024-00730-6","DOIUrl":"https://doi.org/10.1007/s43441-024-00730-6","url":null,"abstract":"Purpose: This study aimed to assess the current regulatory review process of the Zambia Medicines Regulatory Authority (ZAMRA) by identifying the key milestones and target timelines achieved for products approved from 2020 to 2023, as well as good review and quality decision-making practices implemented in the review process.Methods: A standardised, validated questionnaire; Optimising Efficiencies in Regulatory Agencies (OpERA) and the OpERA Data Collection Template were completed by the author.Results: Three review models are used by ZAMRA to review new active substances (NASs) and generic products: verification, for products prequalified by the World Health Organization or approved by a stringent regulatory authority (SRA); abridged, for well-established molecules or SRA-approved products; or full, for products not otherwise prequalified. Good review practices and quality decision-making processes were followed but could be improved.Conclusion: This study assessed the overall ZAMRA operation and identified the key milestones in the review process for products approved from 2020 to 2023, target timelines achieved and the compliance to standard good review and quality decision-making practices.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142898311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Descriptive Analysis of Good Clinical Practice Inspection Findings from the Saudi Food and Drug Authority. 沙特食品和药物管理局良好临床规范检查结果的描述性分析。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-12-26 DOI: 10.1007/s43441-024-00731-5

Omaima O Arab, Mohammed Aldayan, Khalid Almowaizri, Ahmad Alghamdi, Jahad Alghamdi, Adel Alharf

{"title":"Descriptive Analysis of Good Clinical Practice Inspection Findings from the Saudi Food and Drug Authority.","authors":"Omaima O Arab, Mohammed Aldayan, Khalid Almowaizri, Ahmad Alghamdi, Jahad Alghamdi, Adel Alharf","doi":"10.1007/s43441-024-00731-5","DOIUrl":"https://doi.org/10.1007/s43441-024-00731-5","url":null,"abstract":"Introduction: The Saudi Food and Drug Authority (SFDA) conducts inspections in accordance with Good Clinical Practice (GCP) to safeguard clinical trial integrity and protect the rights, safety, and welfare of study participants. These inspections ensure that trials are conducted in compliance with GCP and applicable laws.Objectives: The study aims to provide a description of GCP inspection findings, analyze their impact on the clinical trial ecosystem, and provide recommendations to improve clinical trial conduction in Saudi Arabia.Methods: A review was conducted on inspection reports, with two senior independent inspectors examining, collecting, and categorizing the data. Descriptive statistics were used to summarize the categorical variable via frequency distributions.Results: A total of 131 GCP inspections were performed between 2017 and 2023, totaling 722 observations from 116 (88.5%) inspection visits. The remaining 15 (11.5%) inspection visits recorded no observations. The highest number of visits were conducted in contract research organizations (CRO) (n = 50; 38.2%) with 118 observations, followed by clinical investigator sites (n = 46; 35.1%) with 313 observations, then bioequivalence (BE) centers (n = 33; 25.2%) with 256 observations, and the last 2 (1.5%) visits were conducted in phase I clinical trial units with 35 observations.Conclusion: This study assesses GCP inspection reports and examines the types of deficiencies and their grades in each area. Observation categories and grades were found to vary by organization type, which indicates the need for specific action plans addressing each organization type separately. This report provided recommendations based on the most common findings to assist researchers and sponsors when conducting clinical trials in Saudi Arabia.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142898310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety Information. 基于日本安全信息的药品安全信号检测参考集的研制。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-12-21 DOI: 10.1007/s43441-024-00729-z

Satoru Ito, Mamoru Narukawa

{"title":"Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety Information.","authors":"Satoru Ito, Mamoru Narukawa","doi":"10.1007/s43441-024-00729-z","DOIUrl":"https://doi.org/10.1007/s43441-024-00729-z","url":null,"abstract":"Introduction: One of the main objectives of pharmacovigilance activities is to confirm unknown adverse drug reactions (ADRs), and data-mining methods have been developed to detect signals that are candidates for ADRs. Reference sets have been developed to evaluate the performance of the data-mining methods. However, reference sets generated in previous studies are not based on Japanese safety information; therefore, they are not suitable for use in evaluation studies in Japan because some drugs have not been approved or marketed for a long time in Japan. This study aimed to develop a reference set using drug safety information marketed in Japan and to evaluate its performance.Methods: A reference set was developed for 43 drugs and 15 events. For each combination of the selected drug and event, those that were listed as important identified risks in the Japan Risk Management Plan (J-RMP) were set as \"positive controls\" and those that were not listed as adverse reactions in the package insert were set as \"negative controls.\" In addition, we performed data-mining using Japanese Adverse Drug Event Report database (JADER) and evaluated the results against the reference set to empirically confirm its effectiveness.Results: The reference set included 127 positive and 386 negative controls. A comparison of the signals obtained from data-mining using JADER with the reference set revealed higher correlations than those in previous studies.Conclusion: A reference set was developed using the safety information of drugs approved in Japan to promote research on data-mining methods.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Consumer Understanding of Prescription Drug Indications in Direct-to-Consumer Television Advertisements. 消费者对直接面向消费者的电视广告中处方药适应症的理解。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-12-19 DOI: 10.1007/s43441-024-00732-4

Helen W Sullivan, Kathryn J Aikin, Mihaela Johnson, Kate Ferriola-Bruckenstein

{"title":"Consumer Understanding of Prescription Drug Indications in Direct-to-Consumer Television Advertisements.","authors":"Helen W Sullivan, Kathryn J Aikin, Mihaela Johnson, Kate Ferriola-Bruckenstein","doi":"10.1007/s43441-024-00732-4","DOIUrl":"10.1007/s43441-024-00732-4","url":null,"abstract":"Background: Prescription drugs may be indicated to treat more than one medical condition, and companies may promote more than one indication in the same direct-to-consumer (DTC) ad. This study examined how presenting multiple prescription drug indications in one DTC television ad affects consumers' processing of drug information.Methods: We conducted two studies with adults diagnosed with diabetes (Study 1, N = 408) or rheumatoid arthritis (Study 2, N = 411). We randomly assigned participants to view one of three television ads: primary indication only (Study 1: diabetic peripheral neuropathy; Study 2: rheumatoid arthritis), primary plus a similar secondary indication (Study 1: fibromyalgia; Study 2: psoriatic arthritis), or primary plus a dissimilar secondary indication (Study 1: generalized anxiety disorder; Study 2: ulcerative colitis).Results: Remembering and understanding the primary indication was not significantly affected by the presence of a secondary indication (similar or dissimilar). Higher health literacy participants remembered and understood secondary indications.Conclusions: Including a second indication in DTC television ads does not appear to have detrimental effects and can increase awareness of the second indication for some participants. Industry and regulators should continue to ensure DTC promotion is truthful and non-misleading, irrespective of the number of indications presented.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142865540","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0