Eyes on the Prize: Decoding the Ophthalmic Product Regulations and Intricacies of the U.S. Food and Drug Administration Approval.

The dynamic and continuously evolving field of ophthalmology necessitates rigorous regulatory oversight in the United States. This review outlines the multifaceted Food and Drug Administration's (FDA) approval process for ophthalmic products, detailing the classifications, pathways, and regulatory compliance for devices, drugs, biologics, and combination products. Particular emphasis is placed on distinct frameworks for Class I, II, and III devices, as well as regulations for drugs, biologics, and combination products. The organizational structure of the FDA is detailed, with highlights on specific Ophthalmology oversight divisions, historical regulatory evolution, and initiatives such as Patient-Focused Drug Development. An in-depth examination of the regulatory journey, ranging from initial research to post-marketing surveillance, includes practical guidance through stages such as Pre-Investigational New Drug/Pre-Submission consultations, clinical trials, new drug application/biologics license application/premarket approval submissions, and FDA advisory committee interactions. The article underscores the importance of early interactions with the health authorities, interdisciplinary team collaboration, adherence to current standards, and the anticipation of policy changes to ensure patient safety. It concludes with an analysis of 4 key FDA-approved ophthalmic products, including Eylea®, Luxturna®, Alphagan P®, and the Raindrop® Near Vision Inlay, detailing their contributions to ophthalmic care and offering valuable insights into their respective clinical trials, regulatory pathways, and potential implications. These case studies are included to illustrate both successful and failed ophthalmic product launches, thereby highlighting the importance of alignment with regulatory compliance.

Fast-tracking development and regulatory approval of COVID-19 vaccines in the EU: A review of ethical implications.

The rapid spread of SARS-CoV-2 worldwide has triggered intense activity in the field of biotechnology, leading to the development and regulatory approval of multiple COVID-19 vaccines in less than 1 year while raising sustained scrutiny as to the ethical issues associated with this process. This article pursues a twofold objective. First, it reconstructs and provides a thorough overview of the different steps, from clinical trial design to regulatory procedures, underpinning the "fast-tracking" of COVID-19 vaccine R&D and approval. Second, drawing on a review of published literature, the article identifies, outlines, and analyzes the most ethically challenging aspects related to such process, including concerns around vaccine safety, issues in study design, the enrollment of study participants, and the challenges in obtaining valid informed consent. By scrutinizing relevant aspects of COVID-19 vaccine development and regulatory processes leading to market authorization, this article ultimately aims to provide a comprehensive overview of the regulatory and ethical issues underpinning the roll-out of this key pandemic-containment technology worldwide.

Exploring what synchronized physiological arousal can reveal about the social regulatory process in a collaborative argumentation activity.

Combining physiological measures with observational data (e.g., video or self-reports) to further capture and understand the temporal and cyclical process of social regulation has become a trend in the field. Synchronized physiological arousal is a particularly meaningful situation in collaboration. However, little attention has been given to synchronized physiological arousal episodes and their relationship with the social regulatory process. In addition, only a few research utilized heart rate (HR) as a physiological measure in the current collaboration literature. More research is necessary to reveal the potential of HR to expand the diversity of physiological indicators in the field. Therefore, the current study aimed to explore what synchronized physiological arousal can further reveal about the social regulatory process. To achieve this goal, this study designed a collaborative argumentation (CA) activity for undergraduates (mean age 20.3). It developed an arousal-regulation analysis platform, which could automatically detect synchronized physiological arousal in HR and align them with coding challenges and social regulation based on the timeline. In total, 14 four-member groups were recruited. After analyzing both videos and HR data, several findings were obtained. First, only one-third of episodes were synchronized physiological arousal episodes, and the situations where four members were all in arousal states were rare during CA. Second, synchronized physiological arousal was more sensitive to socio-emotional aspects of collaboration as the shared physiological arousal more frequently co-occurred with socio-emotional challenges and socio-emotional regulation, while it happened the least under motivational challenges. Third, synchronized physiological arousal has also been found to be associated with the challenges being regulated. Finally, pedagogical implications were suggested.

Regulating Gene Editing in the Wild: Building Regulatory Capacity to Incorporate Deliberative Democracy.

The release of genetically engineered organisms into the shared environment raises scientific, ethical, and societal issues. Using some form of democratic deliberation to provide the public with a voice on the policies that govern these technologies is important, but there has not been enough attention to how we should connect public deliberation to the existing regulatory process. Drawing on lessons from previous public deliberative efforts by U.S. federal agencies, we identify several practical issues that will need to be addressed if relevant federal agencies are to undertake public deliberative activities to inform decision-making about gene editing in the wild. We argue that, while agencies may have institutional capacity to undertake public deliberative activities, there may not be sufficient political support for them to do so. Advocates of public deliberation need to make a stronger case to Congress about why federal agencies should be encouraged and supported to conduct public deliberations.

The Effect of Grit on Career Adaptability of Chinese College Students Based on the Self-Regulatory Processes.

Intelligence is innate, but grit is something everyone can develop. Grit not only enables students to stick to their goals, but also to persevere even when they fail. Career adaptability is an important concept in vocational education of college students, which is a person engaged in some work, must have a certain physical and psychological quality. Base on the self-regulation theory, this study investigated the relationship between grit and career adaptability of Chinese college student based on the self-regulatory processes. We surveyed 839 Chinese college students and tested a self-regulation model. As expected, grit was related to greater career adaptability via greater career exploration and decision self-efficacy, positive affect, and goal commitment. These findings not only broaden the theoretical framework for the effect of grit on career adaptability, but also open up a new horizon for improving college students' career adaptability in practice.

The drug lag issue: a 20-year review of China.

China has been criticized for the long drug delay for a long time. There was little understanding of Chinese drug lag formation from the investigational new drug (IND) submission to the new drug application (NDA) approval. Therefore, we analyzed the problem of drug lag in China cumulating from the clinical trial starting lag to the lags formed during the regulatory process and discerned the key underlying factors. After investigating the availability in China of new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) between 1999 and 2019, we find that even though cutting regulatory process could reduce the approval lag, the clinical trial starting time in China is more important in drug lag reduction than shortening development time and review time. The reduction of the regulatory process also needs continuous efforts by defining the clinical value based on the medical needs, regulatory procedure harmonization, and intensive discussions between applicants and regulators during the drug development process. Meanwhile, proactive approaches should be taken to encourage developing the first generics in China. More importantly, enhancing domestic research and development capabilities is still the key to cutting the drug lag. Moreover, the China National Medical Product Administration (NMPA) should attach importance to the accumulation of regulation experience on innovative drugs and transform the style of regulating generics to new drugs.

Regulatory standards and processes for over-the-counter availability of hormonal contraception and drugs for medical abortion in five countries in the Eastern Mediterranean Region.

The World Health Organization 2019 WHO consolidated guideline on self-care interventions for health: sexual and reproductive health and rights includes recommendations on self-administration of injectable contraception, over-the-counter (OTC) oral contraception and self-management of medical abortion. A review of the regulatory status of these two self-care interventions can highlight processes required to ensure that the quality of the medicines and safety of individuals are safeguarded in the introduction and scale-up in countries. This review outlines the legal regulatory status of prescription-only medicine (POM) and OTC contraceptives, including emergency contraception, and drugs for medical abortion in Egypt, Jordan, Lebanon, Morocco and Tunisia using information obtained from internet searches, regulatory information databases and personal contacts. In addition, the review examines whether the national medicines regulatory authorities have documented procedures available to allow for a change in status from a POM to OTC to allow for increased accessibility, availability and uptake of self-care interventions recommended by WHO. Egypt, Jordan and Lebanon have a documented national OTC list available. The only contraceptive product mentioned in the OTC lists across all five countries is ellaOne (ulipristal acetate for emergency contraception), which is publicly registered in Lebanon. None of the five countries has an official documented procedure to apply for the change of POM to OTC. Informal procedures exist, such as the ability to apply to the national medicines regulatory authority for OTC status if the product has OTC status in the original country of manufacture. However, many of these procedures are not officially documented, highlighting the need for establishing sound, affordable and effective regulation of medical products as an important part of health system strengthening. From a public health perspective, it would be advantageous for licensed products to be available OTC. This is particularly the case for settings where the health system is under-resourced or over-stretched due to health emergencies. Readiness of national regulatory guidelines and OTC procedures could lead to increased access, availability and usage of essential self-care interventions for sexual and reproductive health and rights.

Comparative evaluation of HET-CAM and ICE methods for objective assessment of ocular irritation caused by selected pesticide products.

Eye irritation potency of pesticides (fungicides, herbicides, insecticides) was comparatively tested by HET-CAM and ICE method. Based on the results of the tests the statistical analysis of agreement between classification using individual methods was done by Goodman-Kruskal's rank correlation and determination (calculation) of Cohen's kappa coefficient. Statistical analysis of agreement between classification revealed significant correlation between results of in vivo and in HET-CAM assays (76%). There was no significant correlation between result of in vivo and in ICE methods (64%). Weakest correlation was found between the data from in vitro HET-CAM and ICE tests. The percentage of agreement between two in vitro data was 48%. They may be recommended as a part of a battery of tests to reduce experimentation on mammals and to limit or eliminate pain and injury inflicted on experimental animals. The HET-CAM test is a useful tool for studying in vivo the potential conjunctival irritation, while the ICE test can be used to study corneal irritant effects in detail.

A chronicle of the 17-alpha hydroxyprogesterone caproate story to prevent recurrent preterm birth.

Preterm birth is a substantial public health concern. In 2019, the US preterm birth rate was 10.23%, which is the fifth straight year of increase in this rate. Moreover, preterm birth accounts for approximately 1 in 6 infant deaths, and surviving children often suffer developmental delay or long-term neurologic impairment. Although the burden of preterm birth is clear, identifying strategies to reduce preterm birth has been challenging. On October 29, 2019, a US Food and Drug Administration advisory committee voted 9 vs 7 to withdraw interim accelerated approval of 17-alpha hydroxyprogesterone caproate for preventing recurrent preterm birth because the called for a confirmatory trial, known as the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery trial, was not confirmatory. The Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery trial included subjects enrolled in the United States and Canada to ensure that at least 10% of patients would be from North America; however, this trial took 9 years to complete and did not demonstrate significant treatment effects in the 2 primary outcomes of interest. Delivery before 35 weeks' gestation occurred in 122 of 1130 women (11%) given 17-alpha hydroxyprogesterone caproate compared with 66 of 578 women (11.5%) given placebo (relative risk, 0.95; 95% confidence interval, 0.71-1.26; P=.72). Similarly, the coprimary outcome neonatal composite index occurred in 61 of 1093 women (5.6%) given 17-alpha hydroxyprogesterone caproate compared with 28 of 559 women (5.0%) given placebo (relative risk, 1.12; 95% confidence interval, 0.68-1.61; P=.73). There was also a lack of efficacy for 17-alpha hydroxyprogesterone caproate treatment in the analysis of a variety of secondary outcomes. Like the Maternal-Fetal Medicine Units Network trial, the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery trial was also flawed. Importantly, the Maternal-Fetal Medicine Unit Network trial was the sole justification for treating women in the United States with 17-alpha hydroxyprogesterone caproate for nearly 2 decades. Currently, despite more than half a century, 17-alpha hydroxyprogesterone caproate still has not been found to be clearly effective. In this context, how does the advising physician dependent on scientific evidence advise a patient that 17-alpha hydroxyprogesterone caproate is effective when the evidence to support this advice has repeatedly been found to be inadequate? This clinical opinion is a critical appraisal of the 2 randomized trials examining the efficacy of 17-alpha hydroxyprogesterone caproate to prevent recurrent preterm birth and a chronicle of events in the regulatory process of drug approval to help answer this question. With this examination, these events illustrate the complexity of pharmaceutical regulations in the era of accelerated Food and Drug Administration approval and characterize the financial impact and influence in medicine. In this report, we also emphasize the value of observational studies in contemporary practice and identify other examples in medicine where accelerated Food and Drug Administration approval has been withdrawn. Importantly, the themes of the 17-alpha hydroxyprogesterone caproate story are not limited to obstetrics. It can also serve as a microcosm of issues within the US healthcare system, which ultimately contributes to the high cost of healthcare. In our opinion, the answer to the question is clear-the facts speak for themselves-and we believe 17-alpha hydroxyprogesterone caproate should not be endorsed for use to prevent recurrent preterm birth in the United States.

The Long and Winding Road of Vagus Nerve Stimulation: Challenges in Developing an Intervention for Difficult-to-Treat Mood Disorders.

PURPOSE: The Vagus Nerve Stimulation (VNS) Therapy System has been studied for more than 20 years in patients with severe, treatment-resistant, chronic mood disorder, i.e., difficult-to-treat depression (DTD). This review distills some of the implications of this research for future therapeutic trials in this population. METHODS: A narrative review is provided on VNS in DTD. Protocols for a new, large, sham-controlled trial and a global, longitudinal observational study are described. RESULTS: Following encouraging results in open studies, a randomized, masked, sham-controlled trial of VNS for DTD failed to demonstrate an effect on the primary outcome. The negative results may have been partly due to inadequate treatment duration (10 weeks). In long-term observational studies, adjunctive VNS, combined with treatment-as-usual (VNS+TAU), was administered to more than 1100 DTD patients and compared with TAU alone in more than 400 patients. VNS+TAU had superior antidepressant effects, but maximal symptom reduction was often observed after 12 months or longer of stimulation. VNS+TAU had also marked superiority in durability of benefit. Sustained levels of symptom reduction below the traditional cutoff for response (i.e. < 50%) were associated with improved quality of life. LIMITATIONS: Most comparisons of VNS+TAU and TAU were derived from observational, open label studies. CONCLUSION: The history of VNS in DTD has implications for interventional studies in this population, and perhaps other chronic medical disorders. The slow onset of benefit with VNS necessitates considerably longer controlled observation periods to establish efficacy. Durability of benefit should be routinely incorporated in efficacy assessment. New outcome metrics are needed to both categorically identify clinically meaningful benefit and to integrate information on symptom burden over time.

Regulación y poder empresarial: el caso del transporte público en Santiago (2007-2017) / Regulação e poder de negócios: o caso do transporte público em Santiago (2007-2017) / Regulation and business power: the case of public transportation in Santiago (2007-2017)

Resumen Una plena comprensión de los procesos regulatorios requiere tomar en cuenta su dimensión política, hasta ahora escasamente considerada en la literatura de administración pública. A este objetivo contribuye el concepto de poder empresarial que ha desarrollado la economía política. Como lo demuestra el estudio de caso de Transantiago, resulta de especial interés la vertiente estructural del poder empresarial. El process tracing aplicado al caso de este sistema de transporte demuestra que la incapacidad de las autoridades de imponer sus preferencias se debe principalmente a las restricciones estructurales que enfrentan, cuyos efectos se manifiestan de manera distinta en la etapa de adjudicación de la licitación y en la fase de implementación.

Resumo O pleno entendimento dos processos regulatórios exige considerar sua dimensão política, até agora raramente considerada na literatura da administração pública. O conceito de poder de negócio desenvolvido pela economia política contribui para esse objetivo. Como demonstra o estudo de caso do Transantiago, o poder estrutural dos negócios é de especial interesse. O process tracing aplicado ao caso desse sistema de transporte, inaugurado em 2007, mostra que a incapacidade das autoridades em impor suas preferências se deve principalmente às restrições estruturais que enfrentam, cujos efeitos variam na fase de leilão e implementação do processo de regulação.

Abstract Full understanding of regulatory processes requires taking into account their political dimension, until now rarely considered in public administration literature. The concept of 'business power' developed in comparative political economy contributes to comprehend this dimension. The case study of the transport system "Transantiago" presented in this article demonstrates that businesses' structural power is of special interest. The process tracing applied to the case of Transantiago, shows that the inability of the authorities to impose their preferences is mainly due to the structural constraints they faced. The effects of this inability are observed in the bidding process and in the phase of implementation of the regulation process.

Practical guidance for engaging patients in health research, treatment guidelines and regulatory processes: results of an expert group meeting organized by the World Health Organization (WHO) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

There is increasing emphasis on patient-centred research to support the development, approval and reimbursement of health interventions that best meet patients' needs. However, there is currently little guidance on how meaningful patient engagement may be achieved. An expert working group, representing a wide range of stakeholders and disciplines, was convened by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the World Health Organization (WHO). Through a structured, collaborative process the group generated practical guidance to facilitate optimal patient engagement in clinical development and regulatory decisions. Patient engagement is a relational process. The principles outlined in this report were based on lessons learned through applied experience and on an extensive dialogue among the expert participants. This practice guidance forms a starting point from which tailoring of the approach to suit different chronic diseases may be undertaken.

The role of adaptive trial designs in drug development.

INTRODUCTION: Clinical development of new drugs is a long and costly process. There is a need to find solutions which can improve and shorten this process. By introducing flexibility in to the design of clinical trials, adaptive design contributes to this improvement and allows to reach drug development decisions in a quicker way. Areas covered: We review the main methodological approaches to adaptive trial design, introducing key statistical concepts. For each phase of the clinical development, different uses and implementations of adaptive trial (AD) design are presented and examples of recent clinical trials are given. The guidance documents issued by the US and European regulatory authorities are also presented. Expert commentary: Despite inevitable challenges, prospects of this rapidly evolving approach to drug development are important. Controlling the risk of type 1 error and the potential operational risks which may be associated with adaptive trial strategy is paramount in late phase studies. However, with new methodological work, these risks are now well controlled and adaptive trial design will certainly shape the future of drug development.

Under the Influence: The Interplay among Industry, Publishing, and Drug Regulation.

The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new antidepressant, vortioxetine, we present a case study of the "ghost management" of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased-rather than evidence-based-medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketing of expensive "me-too" drugs with questionable risk/benefit profiles. We offer solutions for neutralizing these economies of influence.

Olefins and chemical regulation in Europe: REACH.

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the European Union's chemical regulation for the management of risk to human health and the environment (European Chemicals Agency, 2006). This regulation entered into force in June 2007 and required manufacturers and importers to register substances produced in annual quantities of 1000 tonnes or more by December 2010, with further deadlines for lower tonnages in 2013 and 2018. Depending on the type of registration, required information included the substance's identification, the hazards of the substance, the potential exposure arising from the manufacture or import, the identified uses of the substance, and the operational conditions and risk management measures applied or recommended to downstream users. Among the content developed to support this information were Derived No-Effect Levels or Derived Minimal Effect Levels (DNELs/DMELs) for human health hazard assessment, Predicted No Effect Concentrations (PNECs) for environmental hazard assessment, and exposure scenarios for exposure and risk assessment. Once registered, substances may undergo evaluation by the European Chemicals Agency (ECHA) or Member State authorities and be subject to requests for additional information or testing as well as additional risk reduction measures. To manage the REACH registration and related activities for the European olefins and aromatics industry, the Lower Olefins and Aromatics REACH Consortium was formed in 2008 with administrative and technical support provided by Penman Consulting. A total of 135 substances are managed by this group including 26 individual chemical registrations (e.g. benzene, 1,3-butadiene) and 13 categories consisting of 5-26 substances. This presentation will describe the content of selected registrations prepared for 2010 in addition to the significant post-2010 activities. Beyond REACH, content of the registrations may also be relevant to other European activities, for example consideration of worker DNELs/DMELs for occupational exposure level setting, discussion of this aspect will be presented for 1,3-butadiene.

Kinetic evidence that methionine sulfoxide reductase A can reveal its oxidase activity in the presence of thioredoxin.

The mouse methionine sulfoxide reductase A (MsrA) belongs to the subclass of MsrAs with one catalytic and two recycling Cys corresponding to Cys51, Cys198 and Cys206 in Escherichia coli MsrA, respectively. It was previously shown that in the absence of thioredoxin, the mouse and the E. coli MsrAs, which reduce two mol of methionine-O substrate per mol of enzyme, displays an in vitro S-stereospecific methionine oxidase activity. In the present study carried out with E. coli MsrA, kinetic evidence are presented which show that formation of the second mol of Ac-L-Met-NHMe is rate-limiting in the absence of thioredoxin. In the presence of thioredoxin, the overall rate-limiting step is associated with the thioredoxin-recycling process. Kinetic arguments are presented which support the accumulation of the E. coli MsrA under Cys51 sulfenic acid state in the presence of Trx. Thus, the methionine oxidase activity could be operative in vivo without the action of a regulatory protein in order to block the action of Trx as previously proposed.

A bula de medicamentos e a regulação de suas configurações em termos de forma e conteúdo no Brasil / The medicine package leaflet and the regulation of its configurations in terms of form and content in Brazil

A bula é um documento técnico – científico, direcionado a profissionais da saúde e pacientes, que acompanha o medicamento para informar sua composição, características e uso. Considerando a importância e complexidade dessas informações técnico-científicas, houve transformações na regulação de seu conteúdo e de seus elementos representativos. Questiona-se, contudo, quais as representações que a informação técnico-científica assumiu em relação à compreensão de seus usuários. Com o objetivo de conhecer e analisar as diversas configurações contemporâneas que a bula de medicamento tem sofrido sob influência dos marcos regulatórios ao longo do tempo, evidenciaram-se as representações que a informação técnico-científica da bula de medicamento vêm assumindo para compreensão de seus usuários. Para tanto, realizou-se este estudo qualitativo centrado em levantamento, identificação, sistematização e análise comparativa dos instrumentos jurídicos que compõem o marco regulatório nacional dessas bulas. Os resultados demonstram que sua regulação possui um arcabouço legal histórico, que vem se desenvolvendo há sete décadas, juntamente com a criação de órgãos de fiscalização em saúde e em vigilância sanitária. É possível notar que o desenvolvimento do processo regulatório das bulas de medicamento, apesar de ocorrer entre longos espaços de tempo, a partir da criação da Agência Nacional de Vigilância Sanitária (1999) e das consultas públicas, começou a ser realizado com um pouco mais de frequência. Assim, nos últimos dez anos, a regulação da bula de medicamento passou a ser mais específica, principalmente quanto aos aspectos de forma e conteúdo...

The medicine package leaflet (MPL) is a technical – scientific document regulated by the government, directed at health professionals and patients in order to inform and instruct its users about the use of a medicine. Considering the importance and complexity of the MPL technical - scientific information for its users, there have been changes in the regulation of MPL´s content and representative elements. It is questionable, however, which representation the MPL technical – scientific information assumed for users’ comprehension. In order to identify and analyze the various configurations the MPL has undergone over time due to the influence of regulatory frameworks, we looked at the representations the MPL technical – scientific information has taken to become adaptable to users’ comprehension. A qualitative study was conducted, focused on surveying, identifying, organizing and reading the legal instruments that constitute the MPL national regulatory framework, observing changes in the regulation over time. The results show that its regulation has a legal history, which has been developing for seven decades, along with the establishment of institutions in health and health surveillance by the government. It is also observed that, in spite of MPL´s regulatory process development occurring over long periods of time, since the foundation of the National Agency for Sanitary Surveillance (1999) and its public inquiries, this process started to be renewed and improved with a little more frequency. Thus, in the last ten years, MPL regulation has become more specific, regarding form and content...

Lessons from reproductive health to inform multipurpose prevention technologies: don't reinvent the wheel.

UNLABELLED: This paper presents the public health rationale for multipurpose prevention technologies (MPTs) for sexual and reproductive health (SRH) based on regional trends in demographic and SRH indicators. It then distils important lessons gleaned from the introduction of contraceptive and reproductive health products over the past several decades in order to inform the development and future introduction of MPTs for SRH. PRINCIPAL RESULTS: A comparison of current demographic and public health regional data clearly revealed that the greatest confluence of women's SRH concerns occurs in sub-Saharan Africa and South/West Asia. These regional overlaps of SRH risks and outcomes present a strong rationale for developing MPTs designed to simultaneously protect against unintended pregnancy, HIV and other STIs. Information from acceptability, marketing, and operations research on the female condom, emergency contraception, pills and intravaginal rings identified key product characteristics and socio-behavioral issues to be considered in the development and introduction of MPTs. Product characteristics such as formulation, duration of action, presence and magnitude of side effects, prescription status (over-the-counter vs. prescribed), provider type and training and user perspectives, all contributed in varying degrees to both provider and user bias, and subsequent uptake of these family planning methods. Underlying socio-behavioral issues, including risk perception, ambivalence, and social costs also contributed to demand and use. Early identification of target populations will be critical to market shaping, demand creation and defining appropriate service delivery channels for MPTs. Ultimately, knowledge, attitudes, perceptions and practices of users (and their partners) will drive the success- or failure- of product introduction. CONCLUSIONS: MPTs provide a compelling response to the multiple and reinforcing SRH risks faced by women in key regions of the world, but specific product characteristics and their socio-behavioral correlates must be taken into account early in the development process. Successful introduction of new MPTs will require solid understanding of socio-behavioral correlates, effective demand generation, appropriate integration into health service delivery systems, quality counseling for proper use and active engagement of both public and private sectors. This article is based on a presentation at the "Product Development Workshop 2013: HIV and Multipurpose Prevention Technologies," held in Arlington, Virginia on February 21-22, 2013. It forms part of a special supplement to Antiviral Research.