Approval Authority Research Articles

Increasing Use of Compassionate Use/Managed Access Channels to Obtain Medicines for Use in COVID-19.

The COVID-19 pandemic has triggered an extensive need for new therapeutics and there has been widespread use of unapproved/repurposed medicines. Several countries have regulations for access to unapproved medicines, known as compassionate use, managed/expanded access or emergency use. The Novartis Managed Access activity for COVID-19 delivered unapproved/repurposed medicines to nearly 6,000 patients over a 6-month period. With the rapid growth of such access mechanisms to address COVID-19, a better understanding of these channels is required.

Decentralization and firm innovation: Evidence from a natural experiment in China

This paper examines the impact of decentralization on firm innovations based on a unique setting in China, the delegation of approval authority for export tax rebate in 2006. Using difference-in-differences approach, we find that 1) export enterprises generate more patents, after the municipal taxation bureaus delegated the authority of export tax rebate approval to lower governments. 2) Placebo tests by falsifying the pilot time and cities establish the causality. 3) The effect is particularly more pronounced for export enterprises with higher financial constraints, higher information asymmetry and weaker relationship with local governments. Overall, this study provides new insight about the real effect of the decentralization of government activities on firm innovations, which may be of interest to regulators who are concerned with the authority delegation and simplification of administrative procedures.

Experimental results of a national technical assessment procedure on commercial FRP for structural strengthening: wet-lay-up systems

The paper shows the results of a large experimental activity for the qualification of wet-lay-up FRP products for structural repair and/or strengthening, required by the Italian national approval authority. The qualification procedure and the correspondent design rules are described in national guidelines. The analysis of the experimental results of a large number of qualification tests allows to highlight some aspects in the national procedure that could be addressed in a future revision of the guidelines. In particular, statistical analyses were carried out in order to assess the most suitable probabilistic models able to describe the experimental distribution of the tensile strength and the Young’s modulus of FRP wet-lay-up materials falling in the same class. The analyses were developed with reference to both ordinary and artificial environmental conditions. Nevertheless the paper is focussed on the case of wet-lay-up FRP materials, it can be considered exemplary of a problem common to other products.

New Approaches in Breast Cancer Therapy Through Green Nanotechnology and Nano-Ayurvedic Medicine - Pre-Clinical and Pilot Human Clinical Investigations.

PurposeThe overarching objective of this investigation was to investigate the intervention of green nanotechnology to transform the ancient holistic Ayurvedic medicine scientifically credible through reproducible formulations and rigorous pre-clinical/clinical evaluations.MethodsWe provide, herein, full details: (i) on the discovery and full characterization of gold nanoparticles-based Nano Swarna Bhasma (henceforth referred to as NSB drug); (ii) In vitro anti-tumor properties of NSB drug in breast tumor cells; (iii) pre-clinical therapeutic efficacy studies of NSB drug in breast tumor bearing SCID mice through oral delivery protocols and (iv) first results of clinical translation, from mice to human breast cancer patients, through pilot human clinical trials, conducted according to the Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (abbreviated as AYUSH) regulatory guidelines of the Government of India in metastatic breast cancer patients.ResultsThe preclinical in vitro and in vivo investigations, in breast tumor bearing mice, established unequivocally that the NSB Nano-Ayurvedic medicine-gold nanoparticles-based drug is highly effective in controlling the growth of breast tumors in a dose dependent fashion in vivo. These encouraging pre-clinical results prompted us to seek permission from the Indian Government’s holistic medicine approval authority, AYUSH, for conducting clinical trials in human patients. Patients treated with the NSB drug capsules along with the “standard of care treatment” (Arm B) exhibited 100% clinical benefits when compared to patients in the treatment Arm A, thus indicating the tremendous clinical benefits of NSB drug in adjuvant therapy.ConclusionWe have succeeded in clinically translating, from mice to humans, in using proprietary combinations of gold nanoparticles and phytochemicals to develop the Nano-Ayurvedic drug: Nano Swarna Bhasma (NSB), through innovative green nanotechnology, for treating human metastatic breast cancer patients.

Sacco’s Strategies and Member’s Savings in Deposit Taking Saccos in Nairobi County- Kenya

Just like the case with all investments and other firms, Savings and Credit Co-operative Societies (SACCOs) in Kenya are investment with the target of maximizing their wealth. It is that wealth maximization and capital accumulation is a critical objective whenever SACCOs have chosen pushes for more savings from members. The purpose of the study was to conduct an effect analysis of savings and credit co-operative societies strategies on member’s savings in Sacco’s’ (Nairobi county- Kenya). Specifically, the study focused on the following research objectives; to establish the relationship between loan policies, member training and customer relationship management strategy on member’s savings in Sacco’s in Nairobi County. The study targeted the forty two licensed savings and credit co-operative societies in Nairobi County-Kenya. Specifically the study targeted the management of the Sacco’s, and clients of savings and credit co-operative societies in Nairobi County-Kenya. From the projected target population which was about 12,212 respondents. A purposive sampling technique was employed in this study. Then, simple random sampling procedure was then used to select about 50% of the Sacco’s management/staff targeted from the target population. Then purposively again a random sampling technique was employed to select at least two Sacco’s clients at each office visited from the 42 registered Sacco’s in Nairobi County. In analysis, Descriptive and inferential statistics were considered to conduct an analysis of data generated from respondents. The information obtained was presented through frequency distributions tables, evidence of percentages and the researcher categorized variables. The study found that loan policies, member training and customer relationship management strategy positively and significantly affected member’s savings. The study concluded that it is a SACCO policy to appraise loans based on members’ savings and ability to repay. However, a member needs to clear any outstanding emergency loan, if any, before applying for another. Training of members both employees and clients leads to increased job satisfaction and morale among employees, motivation, increased efficiencies in processes, resulting in financial gain, increased capacity to adopt new technologies and methods by clients, increased innovation in strategies and products and enhanced company image. Customer relationship management strategy enhances better customer service, CRM systems are useful in identifying potential customers, CRM data ensures effective co-ordination of marketing campaigns. The study recommended that loan policy should clearly communicate the strategic goals and objectives of the SACCO, as well as define the types of loan exposures acceptable to the institution, loan approval authority, loan limits, loan underwriting criteria, and several other guidelines. SACCO should train members on communications; because the increasing diversity of today’s workforce brings a wide variety of languages and customs. Customer service; because increased competition in today’s global marketplace makes it critical that employees understand and meet the needs of customers. Customer relationship strategy should aim at governing how to satisfy customers beyond developing good products and services, help retain existing customers to maximize efficiencies and reduce the cost of acquisition and ensure customer satisfaction and a memorable brand experience.

BIM for public authorities: Basic research for the standardized implementation of BIM in the building permit process

The building permit is an indispensable connection between the approval authority and the executive client within the construction process. Moreover, sustainability criteria do not have sufficient regard in the building permit process in the area of research. To lay the foundation for a state-of-the-art digitalization of the building permit process, the study identifies the information requirements relevant to implement the BIM methodology taking into consideration the available sustainability aspects relevant to the process. A detailed evaluation of the building permit process and the analysis of projects that have gained building permission in the last five years in the area of study of South Tyrol (Italy) gives us a better understanding of the organizational structure and responsibilities in the process. The authors use the data of in-depth process analysis to assess a defined catalogue of basic requirements for BIM methodology in the building permit process. As a result, the analysed BIM-integrated approach enables an early-stage identification of approval compliance, which can be evaluated in the building permit process. A good understanding of the current process must be considered a key factor of a successful introduction of BIM for the building permit procedure.

ETIOSARC study : environmental aetiology of sarcomas from a French prospective multicentric population-based case–control study—study protocol

IntroductionSarcomas are rare tumours of connective tissue. The exact overall incidence of sarcomas is unknown due to diagnostic difficulties and the various histological subtypes (over 80 subtypes). However, the apparent...

The Perfect Storm: Puerto Rico’s Evolving Debt Crisis Under PROMESA

In 2015, domestic and international creditors were bracing for a historic financial event as the United States territory Puerto Rico teetered on the brink of catastrophic default. After almost a decade of economic headwinds, substantial money-borrowing, and poor fiscal management, Puerto Rico’s financial condition was quickly deteriorating. However, the island’s legal status as a territory made it impossible for the government to take advantage of the U.S. Bankruptcy Code to renegotiate its debt with institutional investors. After the Supreme Court denied the island’s own attempt to construct a restructuring process, Congress finally stepped in and enacted the Puerto Rico Oversight, Management, and Economic Stability Act in the summer of 2016. The Act, commonly referred to as PROMESA, creates a novel framework under which Puerto Rico can renegotiate its credit commitments and hopefully regain access to the credit market sometime in the future. In particular, PROMESA creates the Financial Oversight and Management Board (FOMB), which is an independent organization with oversight and approval authority over much of the Puerto Rico bankruptcy process. However, because PROMESA as a legislative act is new and untested, several interesting questions arise as to the law’s infrastructure around accountability of entities such as the FOMB. These questions are especially salient as Puerto Rico is the first U.S. territory to become insolvent; therefore, how these bankruptcy proceedings unfold will serve as important precedent for other territories or municipalities that may find themselves bankrupt. This Note focuses on the FOMB and whether stakeholders, such as creditors or Puerto Rican citizens, can judicially challenge the fiscal decisions made by the FOMB throughout this restructuring process. While this Note ultimately concludes that stakeholders may not have a strong legal argument to reverse the FOMB’s financial determinations in court, it also proposes that stakeholders may be more successful in appealing to congressional representatives to ensure that their voices are heard and their interests are accounted for throughout these unprecedented proceedings.

Wind power development, government regulation structure, and vested interest groups: Analysis based on panel data of Province of China

Under pressure to reduce emissions and protect the environment, China has been vigorously promoting the development of renewable energy. In recent years, wind power generation in China has developed very quickly, but its overall use ratio is very low and there are still many obstacles impeding further development of wind power. Firstly, this paper systematically analyzes the relationship between different influencing factors of wind power growth, including the level of government regulation and the impact of vested interest groups, based on the private interest theory of government regulation. Secondly, we use panel data from 31 Chinese provinces to examine the theoretical assumptions. The results show that the delegation of approval authority led to the growth of regional wind power installed capacity. The influence on local government by the local thermal power industry exerted a negative impact on the development of local wind power when the local government held the approval authority. However, this influence relation disappeared when the central government held the approval power. Thus, the government needs to make a trade-off between different levels of approval authority. The paper concludes with several suggestions to promote China's wind power development.

Us Medical Devices: Choices and Consequences

The FDA’s system for regulating medical devices has been criticized for retarding innovation because it adds uncertainty and costs to the invention process and delays the approval of devices. Because this system was created 40 years ago, it does not reflect societal changes in information technology, our understanding of safety, and international trade. Recent attempts to improve it by taking patient preferences into account are misguided because patient preferences are individualized: what is needed is a system that caters to individual risk-benefit preferences. We conclude that a new system of medical device approvals is needed—one that grants approval authority to multiple private bodies, allowing them to compete with the FDA and each other on the price, quality, and timeliness of approvals. Such a system would cater to healthcare entities’ and patients’ individual risk-benefit preferences. It would also spur innovation at a much greater rate than does the current institutional arrangement.

Practice of " Management Regulation of Medical Institutions" based on the questionnaire

Objective To learn the comments on the practice of Management Regulations of Medical Institutions(Regulations below) by those related to such Regulations. And to identify problems found in the application. Methods A questionnaire was designed by means of literature review and expert brainstorming, to learn the awareness of the respondents on the Regulations, and their comments on regional planning of medical institutions, setup approval authority, classification of medical institutions, and regulators of these institutions. A total of 1 000 questionnaires were delivered to medical institutions, health administrative authorities and patients at large 854 valid questionnaires were recovered, with the data analyzed in descriptive statistics. Results 90.7% of the respondents supported the revision of the main contents of the Regulations. 54.3% of them held that not all types of medical institutions need to be limited by regional planning; 69.1% of them held that the regulatory powers of different rankings on the business approval need to be revised; 56.9% of them held that the Regulations should clarify the legal status of other regulatory authorizes over medical institutions. The respondents also named 11 articles of the Regulations to be added. Conclusions A number of articles of the Regulations need to be revised, such as those on setup approval and classified administration, to meet administrative needs and medical institutions′ development needs. In the meantime, interest relationship of health administrators, medical institutions and patients should be taken care of as well. Key words: Hospital administration; Management Regulations of Medical Institutions; Medical legislation; Questionnaires; Revision suggestions

Overview of Provisions for Import of Medical Devices into India under Central Licensing Approval Authority (CLAA) Scheme and Medical Device Rules, 2017

Background: The Government of India regulates medical devices through a specialized division called, Medical Device and Diagnostics Division, CDSCO, Min of Health and Family Welfare. Earlier, only 14 categories of Medical Devices, called Notified Devices were regulated under CLAA scheme for the purpose Manufacture, Import, Sale and Distribution. On 17th October 2016, a draft of rules, called Medical Device Rules, was published by Ministry of Health and Family Welfare, in Official Gazette, for feedback from industry. </P><P> Objective: In this paper we would examine the provisions for import of Medical Devices under CLAA scheme and Medical Device Rules, 2017 and make easier to grasp the regulatory system of India for any manufacturer who wishes to enter Indian Market. </P><P> Discussion: After due consideration, the Medical Device Rules, 2017 were passed and set for implementation by 1st January 2018. This will create a separate registration and oversight system for drugs and medical devices. Drug Controller General of India would remain the Licensing Authority for Import of devices under the new system. Indian Medical Device Industry is primarily import oriented. Indian Market presently offers tremendous opportunities for high-end sophisticated device manufacturers as most of the high end innovative products are imported into the country. The import of medical devices for the year 2016, stood at $208,230.65 million.

Observational study of the development and evaluation of a fertility preservation patient decision aid for teenage and adult women diagnosed with cancer: the Cancer, Fertility and Me research protocol

IntroductionWomen diagnosed with cancer and facing potentially sterilising cancer treatment have to make time-pressured decisions regarding fertility preservation with specialist fertility services while undergoing treatment of their cancer with oncology...

Author’s Response: A Corruption Market More Sophisticated Than You Think

The criticisms and comments of the three distinguished participants in this roundtable cover a wide range of issues, and it is impossible to address all of them here. In the space below, I respond to three main concerns about China's Crony Capitalism: The Dynamics of Regime Decay raised in their reviews: (1) theoretical framework and arguments, (2) empirical evidence and interpretation, and (3) implications of the findings.Theoretical Framework and ArgumentsThe book's main theoretical contribution is to offer an institutional explanation for the emergence of a particular type of corruption-collusive corruption perpetuated mainly to enable political and business elites to loot nominally state-owned assets at steep discounts or no cost. It traces the rise of this type of looting to a series of changes in China's property rights regime in the post-Tiananmen era that significantly decentralized control rights without clarifying ownership rights. The main theoretical argument itself is straightforward. In the context of other significant decentralizing institutional changes that have granted local-level officials enormous discretion (most critically power over personnel appointments), the combination of decentralized control rights and unclear ownership rights (or, strictly speaking, the absence of real owners) creates an ideal environment for political and business elites to collude and loot valuable assets such as land, mining resources, and assets in state-owned enterprises (SOE). Collusion is necessitated by both the decentralization of control rights (with multiple officials empowered with approval authority) and unclear ownership (which attracts multiple claimants). The same logic and institutional conditions also apply to the widespread collusive corruption in infrastructure investments.This theoretical framework offers an original explanation for the rise of collusive looting in the post-Tiananmen era. It does not, however, claim to explain all forms of corruption, as Yan Sun implies. The type of corruption she identifies is best characterized as garden-variety theft or petty corruption, not looting. So the analytical framework centered on property rights does not explain garden-variety theft. But how do we account for the rise of collusion in corrupt activities that do not involve the looting of state-owned assets? In the book, there are three sets of cases where property rights are not directly involved: the purchase and sale of public office, collusion between law enforcement and organized crime (although in at least 20% of the cases crime bosses gained undervalued land and mines with the help of local officials), and collusive corruption in courts and regulatory agencies. It is instructive to note that in these cases the median corruption income of the chief official perpetrator ranges between 510,000 and 760,000 yuan-a fraction of the median corruption income of the chief official perpetrator colluding with businessmen (9.5 million yuan) and the median corruption income of the chief perpetrator of collusive corruption in SOEs (6.4 million yuan) (pp. 120 and 155). The huge disparity in corruption income confirms the importance of property: officials engaged in garden-variety theft get paid for services, whereas those engaged in collusive looting are rewarded much more handsomely for obtaining undervalued or costless public assets.The purchase and sale of public office constitute a critical linkage in the formation of collusive networks in the Chinese political system. Sun does not believe that China's Crony Capitalism provides evidence showing that party chiefs sold offices to subordinates explicitly to facilitate their corrupt activities (including doling out undervalued state-owned assets to their business cronies). This is not true. Of course, due to the limited information revealed in the official media and court documents, it is impossible to build an overwhelming case demonstrating this connection. …

Use of Medical Mobile Applications Among Hospital Pharmacists in Malaysia

Handheld computers (HHCs) such as smartphones and tablets are providing a variety of drug information (DI) applications to assist pharmacists' decision making in the clinical and hospital setting. However, little is known about the extent of their use among Malaysian pharmacists. The current study aimed to assess the use of electronic DI resources via HHCs by pharmacists in Malaysia. This study also aimed to investigate the pharmacists' perception toward the DI content and functions of mobile medical applications. A convenience sampling method was adopted to invite pharmacists (N = 450) working in various sectors such as hospitals, the drug approval authority, and academia to participate in this online survey. A 36-item questionnaire was administered, and data were summarized and presented using descriptive statistics. The response rate to this survey was 49.8% (n = 224). Overall, 213 respondents (95.1%) were active HHCs users in their daily clinical practice. About 194 respondents (86.6%) disclosed that they often use HHCs for searching DI. Dosage recommendations (n = 198; 88.4%), adverse drug reactions (n = 153; 68.3%), and drug interactions (n = 146; 65.2%) were the most common DI retrieved. Meanwhile, general dosage recommendation, pediatric dosage recommendations and dosage recommendations for renal failure were ranked as the most important DI in mobile medical applications. Gaining access to the latest information on drugs and clinical practice were regarded as the most important functions of the mobile medical app. The use of HHCs for DI among pharmacists in Malaysia was high. The use of locally produced DI sources is still low compared to overseas sources. The most popular applications used for drug-related medical information were Micromedex, followed by Lexicomp and Medscape.

Project splitting in environmental impact assessment

This paper discusses project splitting in environmental impact assessment (EIA), investigating the current state of knowledge through literature, legislation, case-law and practice, discussing problems and providing solutions. The focus is on Spain, but many of the conclusions are applicable worldwide. Project splitting is a much more common practice than generally accepted. The main efforts have been focused on preventing salami-slicing as a mechanism to avoid the EIA, but it is a much more complex problem, with different ways of splitting and reasons for doing so. Measures to avoid this practice should include strengthening the strategic environmental assessment, a greater involvement of the approval authority, specific prohibitions in regulations, using case-by-case examinations instead of thresholds, compulsory scoping and avoid the exclusion of project parts during the EIA.

Institutional Autonomy in Allocation of Income among the Various Categories of Expenditure in Higher Education: A Case of Makerere University

This study examined institutional autonomy in allocation of income among the various categories of expenditure at Makerere University. Drawing on case study design, secondary data was obtained and analysed thematically. The study revealed that Makerere University had the autonomy to generate funds; and existing policy indicates that various categories of expenditure were autonomously determined because approval authority lied with specific levels of management within organisational units; and block funds to Makerere allowed departments and faculties to autonomously allocate funds. However, the findings reveal that despite autonomous allocation of income and expenditure being stipulated by policy, actual allocation of incomes among different categories of expenditure remained with top management and was diminishing at lower units. Therefore, it was recommended that institutions of higher learning need to increase their incomes in order to promote institutional autonomy in allocation of income among the various categories of expenditure.

Trade Treaties: Undemocratic, Anti-Competitive and Unbalanced?

The major benefit from free trade is from domestic reform (Section 2A). Current preferential trade treaties have large sections concerning the wide range of domestic regulation that might impede trade in agriculture or services (Section 2B). These regulatory sections are highly detailed and prescriptive – the worst form of old-fashioned heavy-handed regulation (Section 2C). They need to be replaced by modern outcome-oriented objectives, with countries free to implement these as best fits other social, cultural and economic goals.As trade treaties receive little attention during elections a mandate cannot reasonably be claimed (Section 3A). These treaties tie the hands of both the current and future governments across a wide range of domestic regulation – open debate about these goals and the best means of achieving them is essential. Such an open agenda would re-build trust in government and better suit decision-making processes in a democracy. An important part of this would be independent evidence-based analysis by a trusted body (Section 3B). This would provide a factual basis for any consultations (Section 3C).The submission also considers what fair trade provisions might look like. The elements of a fair, balanced, patent policy are set out in Section 4A. These are assessed against our current treaties in Section 4B. There is a large gap. Many of our treaties fail the TRIPS Article 7 test of what a fair balanced patent policy should look like. The most essential first steps in ensuring that preferential trade treaties are democratic, procompetitive and balanced are to ensure that there is independent evidence-based assessment of the proposed content, and that the approval authority rests with parliament. Ideally there should be an active economic reform agenda, with full public debate of all the options likely to be included in trade treaties.

Assessment of Institutions in Sustainable Urban-Management Effects on Sustainable Development of Tehran: Learning from a Developing Country

AbstractLand-use patterns are important to urban planning and management and face challenges from market forces, government, and local urban management in Iran. This research examines the problems arising from such issues in the comprehensive urban-planning and management system. The Article Five Commission (AFC) of Tehran is a legal intersectoral institution for urban planning intended to coordinate the actions of organs influential in the development of Tehran. It acts as the supreme decision-making authority for approval of detailed plans and land-use change for the city. The AFC as a legal institution that can take action to preserve sustainable urban development (SUD) by approving or rejecting land-use-change proposals with the goal of preserving the social benefits and public rights of residents. This study evaluated the effective factors for the function and positions of the AFC toward SUD of Tehran. It used an analytical survey that collected data using documentary methods and a questionnaire on t...

States with stronger health insurance rate review authority experienced lower premiums in the individual market in 2010-13.

States have varying degrees of review authority over health insurance carriers' rates, including prior approval authority over proposed rates and requirements for loss ratios, the proportion of premium revenues spent on medical claims. The Affordable Care Act (ACA) requires carriers in certain categories of health insurance to provide public justification for rate increases of 10percent or more. We collected data on how states changed their rate review authority and requirements during 2010-13, the years immediately after enactment of the ACA, and we combined these data with carrier filings. We found that adjusted premiums in the individual market in states that had prior-approval authority combined with loss ratio requirements were lower in 2010-13 ($3,489) than premiums in states with no rate review authority or that had only file-and-use regulations, which gave the states no authority to block rate increases ($3,617). Adjusted premiums declined modestly in prior-approval states with loss ratio requirements, from $3,526 in 2010 to $3,452 in 2013, while premiums increased from $3,422 to $3,683 in states with no rate review authority or file-and-use regulations only. Our findings suggest that states with prior approval authority and loss ratio requirements constrained health insurance premium increases.