In recognition of the morbidity and mortality associated with human immunodeficiency virus (HIV), the Joint United Nations Programme on HIV/acquired immunodeficiency syndrome (AIDS) (UNAIDS) aims to end the epidemic by setting and striving to achieve the ambitious 95-95-95 targets. However, Singapore is still not performing well in the first UNAIDS target. The National HIV Programme (NHIVP) developed this set of recommendations based on an adaptation of major international guidelines from the World Health Organization and the US Centers for Disease Control and Prevention. The goals of this recommendation are: (1) to increase the uptake of HIV testing; (2) to allow earlier detection and identification of individuals with unrecognised HIV infection; (3) to facilitate linkage to clinical services; and (4) reduce further transmission of HIV infection in Singapore.
Humans ; Singapore/epidemiology* ; HIV Infections/epidemiology* ; United States ; HIV Testing ; Mass Screening ; World Health Organization ; Practice Guidelines as Topic ; Centers for Disease Control and Prevention, U.S. ; National Health Programs

Signal detection is a critical task in drug safety regulation. However, it inevitably generates irrelevant or false signals, posing challenges for resource allocation by marketing authorization holders. To reasonably assess these signals, different countries have established various principles for prioritizing the evaluation of risk signals. This study systematically compares these principles and finds that the U.S. Food and Drug Administration(FDA) focuses on practical issues, such as identifying drug confusion or drug interactions. However, China's Good Pharmacovigilance Practices and the European Medicines Agency(EMA) emphasize a comprehensive evaluation framework. The Council for International Organizations of Medical Sciences(CIOMS) emphasizes the consistency of multiple data sources, highlighting the reliability of signal evaluation. China practices a multidisciplinary approach combining traditional Chinese and western medicine, and the risk signals related to traditional Chinese medicine(TCM) have unique characteristics, including complex components, cumulative toxicity, specific theoretical foundations, and drug interactions. The different priorities in risk signal evaluation principles across countries suggest that China should strengthen clinical trial research, emphasize corroboration with evidence of multiple sources, and pay particular attention to the risks of drug interactions in the TCM regulatory science. Establishing the risk signal prioritization principles that align with the characteristics of TCM enables more precise and efficient scientific regulation of TCM.
Humans ; Medicine, Chinese Traditional/standards* ; China ; Drugs, Chinese Herbal/adverse effects* ; United States ; United States Food and Drug Administration

Brain-computer interface (BCI) technology is an innovative and cutting-edge medical advancement that enables direct interaction between the brain and external devices, facilitating the reconstruction of daily functions for patients or serving as a method for neuro-regulation therapy. Although this technology offers a broad range of clinical applications, there are problems as potential risks, individual variations, and the need for long-term monitoring of its effects during utilization. Consequently, the comprehensive evaluation of its safety and effectiveness poses a considerable challenge for regulatory agencies. This study provides a concise introduction to the development history and various types of BCI technology, followed by a summary of the regulatory situation for different types of BCI medical devices in the United States. Furthermore, the regulatory requirements imposed by the US FDA on this product category are analyzed. Finally, the article concludes by presenting a summary and future perspective on the current development of BCI technology, with the aim of offering beneficial insights and guidance for the regulation of BCI medical devices.
Brain-Computer Interfaces ; United States ; United States Food and Drug Administration ; Humans ; Electroencephalography

In recent years, with the development of big data application technology, the real-world data and the corresponding generated real-world evidence have attracted the attention of healthcare regulatory authorities around the world. Regulators recognize that real-world research with specific purposes using real-world data can provide important evidence for regulatory decisions. A total of 90 instances of publicly released on the application of real-world evidence to support regulatory decisions of U. S. Food and Drug Administration are explored, and the positioning and value of real-world evidence in U. S. Food and Drug Administration regulatory decisions are summarized and analyzed, providing references for the use of real-world data and real-world evidence to promote medical devices whole cycle regulation in China.
United States ; United States Food and Drug Administration ; Equipment and Supplies ; Device Approval ; China

OBJECTIVE: This study explored the job choice preferences of Center for Disease Prevention and Control (CDC) workers to provide CDC management information and recommendations for optimizing employee retention and motivation policies. METHODS: A discrete choice experiment was conducted in nine provinces across China. Seven key attributes were identified to analyze the job preferences of CDC workers. Mixed logit models, latent class models, and policy simulation tools were used. RESULTS: A valid sample of 5,944 cases was included in the analysis. All seven attributes significantly influenced the job choices of CDC workers. Heterogeneity analyses identified two main groups based on different levels of preference for attribute utility. Income-prioritizers were concerned with income and opportunities for career development, whereas bianzhi-prioritizers were concerned with bianzhi and welfare benefits. The policy simulation analysis revealed that income-prioritizers had a relatively higher sensitivity to multiple job preference incentives. CONCLUSION Income and bianzhi were the two key attributes influencing the job choices and retention preferences of CDC workers. Heterogeneity in job preferences was also identified. Based on the preference characteristics of different subgroups, policy content should be skewed to differentiate the importance of incentives.
China ; Humans ; Male ; Female ; Adult ; Centers for Disease Control and Prevention, U.S. ; Middle Aged ; Choice Behavior ; Career Choice ; Motivation

In recent years, emerging technology medical devices have developed rapidly. How to more scientifically and more efficiently regulate these novel medical devices so as to improve access to advanced medical technology while ensuring safety and effectiveness is a new challenge faced by regulatory authorities, and is also the core topic of regulatory science. New tools, new standards and new methods are important means to achieve regulatory science. "Medical Device Development Tool" proposed by the U.S. FDA is a novel medical device regulatory science tool, which can help medical device developers to predict and evaluate product performance more efficiently. It is also helpful for regulatory authorities to make regulatory decisions more efficiently. This study introduces the concept, qualification process, role of MDDT in medical device regulation and MDDT examples, and makes some discussion on the device evaluation from the perspective of reliability and validity. MDDT can facilitate the developing of novel medical device.
United States ; Medical Device Legislation ; Reproducibility of Results ; United States Food and Drug Administration ; Technology ; Device Approval

The Ministry of Education and other four departments jointly issued the Notice on the Construction of high-level schools of public Health, proposing that "it will take ten years to build a number of high-level schools of public health, and form a high-quality education development system to adapt to the construction of modern public health system". At present, the construction of high-level public health schools in various universities in China is in full swing. The high-level School of Public Health and the CDC have played an important role in constructing the national public health system and the human health community. The high-level public health schools are of strategic significance and important value to the development of the CDC. The review presents reflections and insights on the role of high-level public health schools in the development of the CDC and the challenges they might face.
Humans ; United States ; Schools, Public Health ; Schools ; Universities ; Public Health ; Centers for Disease Control and Prevention, U.S.

In China, the incidence rate of Hepatitis A has decreased from 56/100 000 in 1991 to 1.05/100 000 in 2020. The number of Hepatitis A outbreaks in China has decreased significantly, however, it has also happened in the last 5 years, and the risk still remains. In order to strengthen the technical guidance for the investigation and control of Hepatitis A outbreak, the Chinese Center for Disease Control and Prevention (China CDC) organized experts in related fields to compile this guideline. The main contents included outbreak definition, outbreak detecting and reporting, outbreak investigation and response, making conclusion and communication. This guideline is intended for use by staff at public health administrative departments, medical and health institutions, centers for disease control and prevention, health supervision agencies at different levels, and other relevant institutions, units and individuals. China CDC will update this guideline periodically based on the progress in this field and feedbacks during the implementation of this guideline.
Centers for Disease Control and Prevention, U.S. ; China/epidemiology* ; Disease Outbreaks/prevention & control* ; Hepatitis A/epidemiology* ; Humans ; Public Health ; United States

Objective To assess the psychological status of staff at the centers for disease control and prevention(CDC) in Sichuan during the outbreak of coronavirus disease 2019(COVID-19) and explore the influencing factors. Methods The staff at Sichuan provincial,municipal,and county(district)-level CDC were selected by convenience sampling.Their basic information,work status,training status,work difficulties,and support from the work group were collected from the self-filled questionnaires online.The Generalized Anxiety Disorder Scale and the 9-question Patient Health Questionnaire were respectively employed to measure the anxiety and depression of the staff.The stepwise Logistic regression was carried out to analyze the influencing factors of anxiety and depression in CDC staff. Results Among the 653 staff,58.35% and 50.06% presented anxiety and depression,respectively.The regression results showed that age(OR=0.95,95%CI=0.92-0.97) and mental support from the work group(OR=0.61,95%CI=0.45-0.82) were the protective factors while physical fatigue(OR=1.82,95%CI=1.20-2.74),work pressure(OR=1.61,95%CI=1.21-2.12),and insufficient protective equipment(OR=1.92,95%CI=1.06-3.49) were the risk factors for depression of CDC staff.Age(OR=0.97,95%CI=0.94-0.99),length of sleep per day(OR=0.74,95%CI=0.56-0.96),and participation in technical training(OR=0.33,95%CI=0.12-0.95) were the protective factors while mental fatigue(OR=1.68,95%CI=1.18-2.41),work pressure(OR=2.94,95%CI=2.08-4.17),and unclear incentive system for overtime(OR=1.99,95%CI=1.23-3.23) were the risk factors for the anxiety of CDC staff. Conclusion The anxiety and depression status of CDC staff during the COVID-19 outbreak were worrying,which were mainly affected by age,sleep,supply of protective equipment,incentive system,fatigue,and work pressure.
Anxiety/epidemiology* ; COVID-19 ; Centers for Disease Control and Prevention, U.S. ; China/epidemiology* ; Cross-Sectional Studies ; Disease Outbreaks ; Humans ; SARS-CoV-2 ; Surveys and Questionnaires ; United States

Single-arm trial refers to a clinical trial design that does not set up parallel control group, adopts open design, and does not involve randomization and blind method. These features, on the one hand, speed up the process of clinical trials, significantly shorten the time to market and meet the needs of patients with advanced malignancies, but also lead to the uncertainty of single-arm clinical trials themselves. Recently, the US Food and Drug Administration held a meeting of the oncologic drug advisory committee to discuss six tumor indications that have been accelerated approved, which once again triggered the discussion of single-arm trials. The basis of accelerated approval by single-arm trial is actually a compromise on the level of evidence-based medical evidence requirements after assessing the benefit risk. Therefore, the sponsor should strictly grasp the applicable conditions of single-arm trial in anti-tumor drugs and conduct single-arm trial scientifically. Post-marketing clinical trial should be implement as early as possible to ensure the benefit of patients. Based on the characteristics of single-arm trial, combined with two guidance relevant to single-arm trial issued by National Medical Products Administration recently, this article is supposed to propose and summarize the strategy of single-arm trial supporting the marketing of anti-tumor drugs.
Antineoplastic Agents/therapeutic use* ; Clinical Trials as Topic ; Humans ; Marketing ; Neoplasms/drug therapy* ; Research Design ; United States ; United States Food and Drug Administration