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This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After providing a brief introduction of the role of the FDA and the scope of the products regulated by the agency, the chapter outlines the common characteristics of premarket controls for drugs, medical devices, and biological products, including how clinical trials of these medical products are conducted with humans as part of the premarket approval process. The chapter then provides a detailed examination of the particular regulatory scheme for each product category. The chapter concludes with an analysis of how FDA regulates emerging medical technologies, such as cellular and tissue-engineered products. FDA regulates a variety of products intended to diagnose, cure, mitigate, treat, or prevent diseases or conditions under a legal scheme established in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and regulations promulgated by FDA. How a product is classified (drug, device, or biologic) forecasts the regulatory approval pathway that must be followed to bring the product to market. This chapter provides education and direction regarding regulatory requirements that must be met to market medical products in the United States.

Purpose – This chapter examines the literature on the dangers of methylmercury exposure and the 2004 Food and Drug Administration/Environmental Protection Agency (FDA/EPA) Advisory on fish consumption. It analyzes the extent to which particular groups of people living in the United States are vulnerable to toxic food consumption and the extent to which the advisories put them at risk.

Design/methodology/approach – The authors conducted a review of the literature related to methylmercury. In addition, they used archival information from government documents. They also analyzed the fish advisories and educational information posted on websites of each state's Women, Infants, and Children (WIC) program.

Findings – Methylmercury is a potent neurotoxin that can seriously affect fetal brain growth and development. Although the federal government promotes canned tuna as an inexpensive, beneficial protein source, recent reports indicate that a large proportion of America's favorite fish contains unsafe levels of methylmercury. Populations at risk for overconsumption include minorities and low-income groups, particularly recipients of federal subsidies such as WIC.

Practical implications – The FDA uses a “nuanced” message to offer consumers information about both the risks and benefits of eating fish. However, the advisory is not widely distributed and information on mercury levels in fish is not available at the point of sale. Minority populations are less likely to be aware of fish advisories and to change consumption habits. Thus, the target population remains largely uninformed and possibly misled about the risks and benefits of eating canned tuna.

Social implications – Based on new data, the federal government should recognize mercury as a hazard, update its consumption guidelines, and better monitor the mercury content in canned tuna. Outreach and educational programs should target minority and at-risk groups. The authors recommend an alternative precautionary approach in dealing with the health threats posed by methylmercury in tuna fish.

Food waste in the hospitality sector has emerged as a global concern. Various technology-driven online food services such as the food delivery apps (FDA) contribute to hospitality food waste. FDA users might behave irresponsibly by ordering more foods than required which may lead to food waste generation. To date, limited studies have been attempted to understand how consumers’ over-ordering behavior through FDA result in hospitality food waste.

The authors used partial least squares structural equation modeling (PLS-SEM) to analyze survey data from 248 FDA users.

The results indicated that perceived convenience and trust positively influence consumers' attitude toward FDA, which in turn promotes over-ordering behavior. Interestingly, the anticipated positive relationship between price advantage and attitude toward FDA was not supported by the data. Furthermore, the authors confirmed that over-ordering behavior contributes to food waste, an outcome that has crucial implications for both the hospitality sector and sustainability efforts.

The current study employs the stimulus-organism-behavior-consequence (SOBC) theory to investigate the catalysts and consequences of over-ordering behavior via FDA. This study thus highlights the importance of the SOBC model in understanding consumer behavior.

A food delivery app (FDA) is a technological advancement connecting restaurants and consumers, making it possible to deliver food home conveniently. The current study seeks to identify the factors affecting consumers' continuance intention and sharing intention toward the FDA in the USA and Canada using an integrated framework built using trust transfer theory and a variety of constructs.

The authors collected data/inputs from 476 respondents in the USA and Canada who had used FDAs in the past and analyzed them using the structural equation modeling technique.

The results indicate that trust in FDA, trust in the user community and commitment affect continuance intention and sharing intention. Interestingly, trust in the seller does not influence commitment, continuance intention and sharing intention. Additionally, the trust disposition and reputation of the FDA play an important role in building trust in FDA.

The present study combines the trust transfer theory with various important constructs such as commitment, trust disposition and reputation of the FDA to build an integrated framework to elucidate the continuance intention and sharing intention toward FDAs.

This study facilitates the FDA providers to understand how trust disposition, the reputation of the FDA and trust in the Internet build trust among FDA consumers. The study also helps them to fine-tune their trust-building strategy by considering several trust targets. It further enables them to appreciate how commitment results in continuance intention and sharing intention toward FDA.

It is an original study investigating the role of various constructs and trust transfer theory in shaping the consumers' continuance intention and sharing intention toward the FDA.

This study aims to establish a comprehensive model integrating variables from the updated unified theory of acceptance and use of technology (UTAUT), expectation-confirmation model (ECM) and trust to determine what factors influence consumers’ decision to continue using food delivery apps (FDA) after the COVID-19 outbreak in Taiwan.

Data was collected from 350 respondents living in Taiwan via Line using a Google Forms link. A total of 333 valid responses were analyzed after 17 invalid questionnaires were eliminated. To test the suggested study paradigm, partial least squares-structural equation modeling was used as the data analysis approach.

The results indicate FDA users’ continuance intention (CI) is directly significantly affected by performance expectancy, satisfaction and habit. All the constructs of the updated UTAUT theory, confirmation and trust significantly influence the satisfaction of FDA, and users’ satisfaction significantly positively impacts users’ CI.

Although consumers’ intentions toward FDA have previously been the topic of research, there is a paucity of literature that discusses the connections between the variables that influence FDA users’ CI after the COVID-19 pandemic in Taiwan. By focusing on the relationships between the multiple antecedents of FDA users’ CI, this study contributes to reducing the existing literature gap. Explanation surrounding the elements influencing FDA users’ CI is provided by examining several aspects of FDA usage, including technological and psychological postadoption issues.

本研究试图建立一个综合模型, 整合了来自统一接受和使用科技理论（UTAUT）、期望-确认模型（ECM）和信任等变量, 以确定影响消费者在COVID-19疫情爆发后继续使用食品外卖应用(FDA)的因素。

本研究针对台湾的居民通过Line平台使用Google Forms链接收集了350份问卷数据, 经过筛选后得到333份有效回复。为了验证所提出的研究范式, 本研究采用了PLS-SEM作为数据分析方法。

结果表明, FDA用户的继续使用意图受到性能预期、满意度和习惯的直接显著影响。UTAUT理论、期望确认和信任显著影响FDA用户的满意度, 而用户的满意度对用户的继续使用意图产生积极影响。

尽管消费者对FDA的意向不是新的研究的主题, 但在讨论COVID-19疫情后影响FDA用户继续使用意图的变量之间的关系方面, 文献中存在不足。通过探索FDA用户继续使用意图的多个前因关系, 本研究有助于弥补现有文献的空白。通过考察FDA使用的技术和心理因素等多个方面, 本研究提供了解释影响FDA用户继续使用意图的论述。

The food industry is continuously developing its online services called food delivery applications (FDAs). This study aims to evaluate FDA's importance–performance and identify strategies to maximize its potential gains from a business partner's perspective.

Data are collected from 208 FDA partners in Indonesia. Importance–performance analysis (IPA) is applied to evaluate the FDA feature and extended the theory of potential gain in customer value (PGCV) to achieve potential gains from FDA business partners.

This study provides a clear and measurable direction for future research to develop FDA performance. Owning customer data, revenue sharing and competitive advantage are the most potential gains from joining the FDA from the business partner perspective.

The respondents are restaurants from the micro, small, and medium enterprises levels. Further research should involve middle to upper level restaurants to discover all business partners' perceptions. This will be very helpful for FDA providers interested in improving the best performance for all their partners.

FDA providers must focus on improving and maintaining the features of owning customer data, revenue sharing, competitive advantage, stable terms and conditions, customer interface, building customer loyalty, online presence, user credit rating, promotion and offers, delivery service and sales enhancement to increase consumer satisfaction and meet the expectations desired by business partners.

This research provides a meaningful theoretical foundation for future work. It extends the theory of PGCV using the value of a partner perspective as a substitute for customer value; hence, the authors call it a potential gain in partner value.

The outbreak of the COVID-19 pandemic has led to the pervasiveness of food delivery apps (FDAs) and the increased scholars’ attention for the topic of FDA continuance usage intention. However, the limited understanding about possible segments of FDA users has hindered food retailers from providing FDAs with a personalized manner, which impairs the effectiveness of marketing strategies. Thus, this study aims to first explore key antecedents of users’ continuance intention toward FDAs and then segment and profile Taiwanese users based on the identified antecedents of FDA continuance intention and demographics.

An online survey was implemented to collect responses from FDA users in Taiwan. With a response rate of 82.4%, the final sample of 326 respondents (average age = 28.3; female = 54.9%) was analyzed by using two techniques of structural equation modeling (SEM) and cluster analysis.

The results indicate six antecedents of users’ continuance usage intention towards FDAs, including information quality, system quality, information quality, perceived usefulness, perceived enjoyment and satisfaction. Additionally, three distinct clusters of FDA users are successfully identified, labeled as “value sensitive users”, “time-sensitive users” and “security sensitive users”.

This study is one of the pioneers that explores the possible segments in FDA market, which helps FDA providers and food retailers develop more focused and appropriate strategies to encourage users to continue using FDAs. Our findings contribute to building an optimized version of “FDA Tech” that becomes an omni-channel solution to serve the increased home-delivery needs in the new normal era.

The study focuses on drug safety regulation capture, reveals the inner mechanism and evolutionary characteristics of drug safety regulation capture and provides suggestions for effective regulation by pharmacovigilance.

The article introduces prospect theory into the game strategy analysis of drug safety events, constructs a benefit perception matrix based on psychological perception and analyzes the risk selection strategies and constraints on stable outcomes for both drug companies and drug regulatory authorities. Moreover, simulation was used to analyze the choice of results of different parameters on the game strategy.

The results found that the system does not have a stable equilibrium strategy under the role of cognitive psychology. The risk transfer coefficient, penalty cost, risk loss, regulatory benefit, regulatory success probability and risk discount coefficient directly acted in the direction of system evolution toward the system stable strategy. There is a critical effect on the behavioral strategies of drug manufacturers and drug supervisors, which exceeds a certain intensity before the behavioral strategies in repeated games tend to stabilize.

In this article, the authors constructed the perceived benefit matrix through the prospect value function to analyze the behavioral evolution game strategies of drug companies and FDA in the regulatory process, and to evaluate the evolution law of each factor.

Food delivery apps (FDA) have been widely adopted by customers in online-to-offline (O2O) catering businesses. This study aims to explore the mechanism regarding the stickiness of FDA and indicates why customers have the intention to reuse them.

A research model was developed based on the e-commerce system successful model (ECSS model) and social influence theory. Using the data collected from 312 customers who have FDA usage experience via an online survey, the established model was empirically assessed by partial least squares based structural equation model.

The results show that factors including information quality, ease of use, convenience and various choices perceived by FDA users are significant antecedents of customer satisfaction and perceived value, which in turn positively influence customers' intention to reuse. Besides, informational social influence and normative social influence play important roles in directly or indirectly affecting customers' intention to reuse.

This study extends the e-commerce system success model and enriches the literature regarding stickiness of FDA. Besides, the understanding of social influence in FDA usage has been deepened by addressing its role in the ECSS model based on the features and contexts of such apps.

The theory of consumption values (TCV) has successfully explained much consumer choice behavior, but few studies have investigated the values that drive food-delivery application (FDA) use. This study aims to bridge this gap by extending the TCV to the FDA context to examine food consumption-related values and interpreting and rechristening generic consumption values to adapt the TCV to the FDA context.

An explorative mixed-method research approach was taken to conduct focus group discussions with 20 target users to develop the questionnaire and then administer it for a cross-sectional survey (pen and pencil) to FDA users aged 22–65 years; 423 complete responses so received were analyzed using structural equation modeling.

The findings show that epistemic value (“visibility”) is the chief driver of purchase intentions toward FDAs, followed by conditional (“affordances”), price (part of functional value) and social value (“prestige”). Food-safety concerns and health consciousness (proposed as part of functional value) did not share any statistically significant association with purchase intentions toward FDAs.

The findings of this study are insightful for FDA service providers competing for higher shares in the market by helping them understand ways to influence consumer choices and purchase intentions.

It is the first study that combines FDAs 2014 an online service that it is attracting a lot of investment 2014and TCV which has continued to be one of the most relevant theories of consumer behavior. It extends the TCV by adapting it to the FDA context with food-consumption-related values. Thus, it adds to the relatively scant literature on FDAs on the whole which is essential, as FDAs represent the business model of new economy, i.e. online-to-offline (O2O). Finally, this study formulates a conceptual framework that may serve as the basis of future research.