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Sample records for english drugs industry

  1. New Zealand's drug development industry.

    PubMed

    Lockhart, Michelle Marie; Babar, Zaheer-Ud-Din; Carswell, Christopher; Garg, Sanjay

    2013-09-13

    The pharmaceutical industry's profitability depends on identifying and successfully developing new drug candidates while trying to contain the increasing costs of drug development. It is actively searching for new sources of innovative compounds and for mechanisms to reduce the enormous costs of developing new drug candidates. There is an opportunity for academia to further develop as a source of drug discovery. The rising levels of industry outsourcing also provide prospects for organisations that can reduce the costs of drug development. We explored the potential returns to New Zealand (NZ) from its drug discovery expertise by assuming a drug development candidate is out-licensed without clinical data and has anticipated peak global sales of $350 million. We also estimated the revenue from NZ's clinical research industry based on a standard per participant payment to study sites and the number of industry-sponsored clinical trials approved each year. Our analyses found that NZ's clinical research industry has generated increasing foreign revenue and appropriate policy support could ensure that this continues to grow. In addition the probability-based revenue from the out-licensing of a drug development candidate could be important for NZ if provided with appropriate policy and financial support.

  2. Drug use in English professional football

    PubMed Central

    Waddington, I; Malcolm, D; Roderick, M; Naik, R; Spitzer, G

    2005-01-01

    Objectives: To examine several issues related to drug use in English professional football. More particularly the project sought to gather data on: players' use of permitted supplements (mineral and vitamin pills and creatine); whether they sought advice, and if so from whom, about their use of supplements; their experience of and attitudes towards drug testing; their views on the extent of the use of banned performance enhancing and recreational drugs in football; and their personal knowledge of players who used such drugs. Methods: With the cooperation of the Professional Footballers Association (PFA), reply paid postal questionnaires were delivered to the home addresses of all 2863 members of the PFA. A total of 706 questionnaires were returned, a response rate of just under 25%. Results: Many players use supplements, although almost one in five players does so without seeking qualified professional advice from anyone within the club. Blood tests are rarely used to monitor the health of players. One third of players had not been tested for drugs within the preceding two years, and 60% felt that they were unlikely to be tested in the next year. The use of performance enhancing drugs appears to be rare, although recreational drugs are commonly used by professional footballers: 6% of respondents indicated that they personally knew players who used performance enhancing drugs, and 45% of players knew players who used recreational drugs. Conclusions: There is a need to ensure that footballers are given appropriate advice about the use of supplements in order to minimise the risk of using supplements that may be contaminated with banned substances. Footballers are tested for drugs less often than many other elite athletes. This needs to be addressed. The relatively high level of recreational drug use is not reflected in the number of positive tests. This suggests that many players who use recreational drugs avoid detection. It also raises doubts about the ability of

  3. Drug Information Residency Rotation with Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Cramer, Richard L.

    1986-01-01

    Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…

  4. Energy and the English Industrial Revolution.

    PubMed

    Wrigley, E A

    2013-03-13

    Societies before the Industrial Revolution were dependent on the annual cycle of plant photosynthesis for both heat and mechanical energy. The quantity of energy available each year was therefore limited, and economic growth was necessarily constrained. In the Industrial Revolution, energy usage increased massively and output rose accordingly. The energy source continued to be plant photosynthesis, but accumulated over a geological age in the form of coal. This poses a problem for the future. Fossil fuels are a depleting stock, whereas in pre-industrial time the energy source, though limited, was renewed each year.

  5. Writing and Thinking about the English Industrial Revolution.

    ERIC Educational Resources Information Center

    Hedberg, Jacqueline H.

    1988-01-01

    Notes that writing can be a more effective tool for social studies learning if assignments require students to generate their own thoughts rather than restate someone else's ideas. Offers a two-day lesson on the reform of child labor practices during the English Industrial Revolution. A wide variety of writing activities are featured. (JDH)

  6. Bioremediation of industrial pharmaceutical drugs.

    PubMed

    Mansour, Hedi Ben; Mosrati, Ridha; Barillier, Daniel; Ghedira, Kamel; Chekir-Ghedira, Leila

    2012-07-01

    Recently, attention has been drawn toward the occurrence of pharmaceuticals in the environment. In recent years, many reports have been made on the occurrence of the large, differentiated group of pharmaceuticals in wastewater (PW), surface water, ground water, and in soil. The pharmaceutical sector is currently expanding in Tunisia, with more than 34 industries. The aim of this work was to evaluate the ability of Pseudomonas putida mt-2 to treat PW. P. putida was very efficient in reducing chemical oxygen demand (COD), total dissolved solids (TDS), and turbidity of solution (85.5, 89.1, and 81.5%, respectively). Genotoxicity of effluent, before and after biodegradation, was evaluated in vivo in mouse bone marrow by assessing the percentage of cells bearing different chromosome aberrations. Results indicated that PW showed a significant ability to induce DNA damage. In addition, PW induced a remarkable lipid peroxidation (LPO) effect, however, activities of both acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE) were unchanged when treated with PW, compared to nontreated PW. This toxicity was imputed to the presence of pharmaceutical compounds in wastewater. However, chromosome aberration, as well as LPO of PW, were significantly reduced after bioremediation. Thus, the use of this strain for testing on the industrial scale seems possible and advantageous.

  7. Drug-induced liver injury and drug development: industry perspective.

    PubMed

    Regev, Arie

    2014-05-01

    Despite intensive ongoing research, drug-induced live injury (DILI) remains a serious issue for care providers and patients, and has been a major cause of drug withdrawal and non-approval by regulatory authorities in the past 50 years. Consequently, DILI remains a major concern for the pharmaceutical industry and a leading cause for attrition during drug development. In most instances, severe DILI is an uncommon idiosyncratic reaction, which typically does not present during preclinical phases or early clinical phases of drug development. In the majority of cases, drugs that caused severe DILI in humans have not shown clear and consistent hepatotoxic signals in preclinical assessment including animal studies, cell cultures, or other methods. Despite intensive efforts to develop better biomarkers that would help in predicting DILI risk in earlier phases of drug development, such biomarkers are currently not supported by sufficient evidence and are not yet available for routine use by drug makers. Due to the lack of effective and accurate methods for prediction of idiosyncratic DILI during preclinical phases of drug development, different drug makers have adopted different approaches, which are often not supported by strong systematic evidence. Based on growing experience, it is becoming increasingly evident that milder forms of liver injury occurring during clinical development, when assessed correctly, may significantly enhance our ability to predict the drug's potential to cause more severe liver injury postmarketing. Strategies based on this concept have been adopted by many drug makers, and are being increasingly implemented during drug development. Meticulous causality assessment of individual hepatic cases and adherence to strict hepatic discontinuation rules are critical components of this approach and have to rely on thorough clinical evaluation and occasionally on assessment by liver experts experienced with DILI and drug development.

  8. The Triumph of the Industrial-Consumer Paradigm and English as the Global Language

    ERIC Educational Resources Information Center

    Spring, Joel

    2007-01-01

    This article considers the role of English as the global language within the industrial-consumer paradigm. In the 21st century, the English language plays a different function in the global economy than it did during the 19th century when it was used as an instrument of cultural imperialism. Today, English serves as a vehicle for participation in…

  9. The Academic English Language Needs of Industrial Design Students in UiTM Kedah, Malaysia

    ERIC Educational Resources Information Center

    Adzmi, Nor Aslah; Bidin, Samsiah; Ibrahim, Syazliyati; Jusoff, Kamaruzaman

    2009-01-01

    The purpose of this study was to analyse the academic English language lacks and needs of Industrial Design students in Universiti Teknologi MARA Kedah (UiTM). It highlights the lacks and needs for English for Academic Purposes in helping the students to succeed in the program through the usage of English language. The research tools used were in…

  10. Growth in an English population from the Industrial Revolution.

    PubMed

    Mays, S; Brickley, M; Ives, R

    2008-05-01

    The rapid urbanization of the Industrial Revolution in 18th-19th century England presented new health challenges. Our aim is to investigate using English skeletal remains whether the living conditions for an urban working class group in the Industrial Revolution negatively impacted upon their skeletal growth compared with a population from a rural agrarian parish. The Industrial Revolution skeletal material is from St Martin's Churchyard, Birmingham (SMB), West Midlands. It dates primarily from the first half of the nineteenth century when Birmingham was a major manufacturing center. The rural group is from Wharram Percy (WP), North Yorkshire, and dates from 10th-19th century AD. The methodology involves plotting diaphyseal bone lengths versus dental age for subadults. No overall difference was found between the two populations in bone length-for-age among the 2- to 18-year cohort. However the younger parts of the SMB cohort were smaller than at WP; the opposite was true of the older parts of the cohort. Growth rate, as inferred from crosssectional data, appeared greater at SMB than at WP. The only result consistent with expectations is the larger bone dimensions in young children from WP, but this likely reflects prolonged breastfeeding at WP not differences in urban and rural environments. That the deleterious health effects that we know accompanied the major transition in human society from a rural agrarian to an urban industrialized living environment should be little manifest in skeletal endochondral growth data is discouraging for those who would use such methodology to monitor health in earlier populations.

  11. 78 FR 37231 - Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing...

  12. 78 FR 52931 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of...

  13. English for Specific Purposes: A Case Study in an Industrial Setting.

    ERIC Educational Resources Information Center

    Alexander, Clare

    A course outline and sample materials for a course in English for garment workshop employees in New York are presented, and theoretical considerations in establishing an English for specific purposes (ESP) course are explored. Attention is directed to the needs analysis process undertaken in the garment industry. Specifically, ESP is used to mean…

  14. Engineering English and the High-Tech Industry: A Case Study of an English Needs Analysis of Process Integration Engineers at a Semiconductor Manufacturing Company in Taiwan

    ERIC Educational Resources Information Center

    Spence, Paul; Liu, Gi-Zen

    2013-01-01

    The global high-tech industry is characterized by extreme competitiveness, innovation, and widespread use of English. Consequently, Taiwanese high-tech companies require engineers that are talented in both their engineering and English abilities. In response to the lack of knowledge regarding the English skills needed by engineers in Taiwan's…

  15. An Assessment of Drug Testing within the Construction Industry.

    ERIC Educational Resources Information Center

    Gerber, Jonathan K.; Yacoubian, George S., Jr.

    2002-01-01

    Investigates the efficacy of workplace drug-testing programs in reducing injury incident rates and workers' compensation experience-rating modification factors within the construction industry. Analyses indicate that companies with drug-testing programs experienced a 51 percent reduction in incident rates within two years of implementation.…

  16. Drug discovery in pharmaceutical industry: productivity challenges and trends.

    PubMed

    Khanna, Ish

    2012-10-01

    Low productivity, rising R&D costs, dissipating proprietary products and dwindling pipelines are driving the pharmaceutical industry to unprecedented challenges and scrutiny. In this article I reflect on the current status of the pharmaceutical industry and reasons for continued low productivity. An emerging 'symbiotic model of innovation', that addresses underlying issues in drug failure and attempts to narrow gaps in current drug discovery processes, is discussed to boost productivity. The model emphasizes partnerships in innovation to deliver quality products in a cost-effective system. I also discuss diverse options to build a balanced research portfolio with higher potential for persistent delivery of drug molecules.

  17. Closing the drug lag for new drug submission and review in Japan: An industry perspective.

    PubMed

    Poirier, A F

    2015-11-01

    Previous publications have focused on drug lag in Japan and the government's initiatives to address the situation.(1) Japan is the third largest pharmaceutical market, and yet has experienced significant drug lag for many years. This article reviews the progress resulting from industry adaptation of new regulatory paradigms that include Japan in global drug development programs.

  18. Homochiral drugs: a demanding tendency of the pharmaceutical industry.

    PubMed

    Núñez, María C; García-Rubiño, M Eugenia; Conejo-García, Ana; Cruz-López, Olga; Kimatrai, María; Gallo, Miguel A; Espinosa, Antonio; Campos, Joaquín M

    2009-01-01

    The issue of drug chirality is now a major theme in the design and development of new drugs, underpinned by a new understanding of the role of molecular recognition in many pharmacologically relevant events. In general, three methods are utilized for the production of a chiral drug: the chiral pool, separation of racemates, and asymmetric synthesis. Although the use of chiral drugs predates modern medicine, only since the 1980's has there been a significant increase in the development of chiral pharmaceutical drugs. An important commercial reason is that as patents on racemic drugs expire, pharmaceutical companies have the opportunity to extend patent coverage through development of the chiral switch enantiomers with desired bioactivity. Stimulated by the new policy statements issued by the regulatory agencies, the pharmaceutical industry has systematically begun to develop chiral drugs in enantiometrically enriched pure forms. This new trend has caused a tremendous change in the industrial small- and large-scale production to enantiomerically pure drugs, leading to the revisiting and updating of old technologies, and to the development of new methodologies of their large-scale preparation (as the use of stereoselective syntheses and biocatalyzed reactions). The final decision whether a given chiral drug will be marketed in an enantiomerically pure form, or as a racemic mixture of both enantiomers, will be made weighing all the medical, financial and social proficiencies of one or other form. The kinetic, pharmacological and toxicological properties of individual enantiomers need to be characterized, independently of a final decision.

  19. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION:...

  20. Drug discovery: new models for industry-academic partnerships.

    PubMed

    Tralau-Stewart, Cathy J; Wyatt, Colin A; Kleyn, Dominique E; Ayad, Alex

    2009-01-01

    The re-focusing of pharmaceutical industry research away from early discovery activities is stimulating the development of novel models of drug discovery, notably involving academia as a 'front end'. In this article the authors explore the drivers of change, the role of new entrants (universities with specialised core facilities) and novel partnership models. If they are to be sustainable and deliver, these new models must be flexible and properly funded by industry or public funding, rewarding all partners for contributions. The introduction of an industry-like process and experienced management teams signals a revolution in discovery that benefits society by improving the value gained from publicly funded research.

  1. 76 FR 72951 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Differentiation of Human Papillomaviruses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Differentiation of Human Papillomaviruses.'' This guidance document provides industry and Agency staff...

  2. Expanding Economic and Industrial Understanding through History and Technology in an English Primary School.

    ERIC Educational Resources Information Center

    Coates, David; Taylor, Paul

    1996-01-01

    Describes a joint history-technology project undertaken with ten- and eleven-year-old students in an English primary school with a view to developing the cross-curricular theme of Economic and Industrial Understanding (EIU). Outlines the classroom course and discusses the principles of EIU in relation to the British National Curriculum. (DSK)

  3. English for Special Purposes in Business and Industry: Suggestions for Program Design.

    ERIC Educational Resources Information Center

    La Perla, Joann

    1988-01-01

    Examines the growing demand for English as a Second Language (ESL) programs in business and industry. Presents study findings on the characteristics of six ESL programs offered in Fortune 500 companies, identifying factors that commonly facilitate or impede ESL program design. (DMM)

  4. 77 FR 58999 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug... regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current...

  5. Drug development: how academia, industry and authorities interact.

    PubMed

    Garattini, Silvio; Perico, Norberto

    2014-10-01

    Unfortunately, abundant examples could be given of pitfalls in the current drug development paradigm-including in the design, conduct and evaluation of phase III clinical trials. This article discusses issues of particular relevance to clinical trials in nephrology, including the inappropriate use of placebo, publication of reports that emphasize potential treatment benefits over adverse reactions, the sometimes dubious impartiality of independent guidelines, and inadequate recruitment of elderly patients. This Perspectives article aims to highlight and summarize the flaws in the current drug development process, while suggesting a way forward that equally satisfies the requirements of academia, patients and the pharmaceutical industry. We suggest improvements to the drug development process and related legislation that intend to balance public needs with commercial aims and ensure effective drug evaluation by regulatory authorities.

  6. [Veterinary Drug 'what'? Various marginal notes by an 'industrial veterinarian'].

    PubMed

    Hoftijzer, J

    1987-04-15

    A retrospective view of the history of the Veterinary Medicinal Products Act and the current situation of the trade in veterinary drugs is followed by a discussion of a number of changes which will have to be made in the fields of production, packing, distribution and the trade in these drugs. With regard to these last-named items, a connection with the Act on the Practice of Veterinary Medicine should be made. In general it can be stated that the innovating industry is not dissatisfied, but only the actual enforcement of the act will provide genuine replies to questions which are still unanswered.

  7. Industrial natural product chemistry for drug discovery and development.

    PubMed

    Bauer, Armin; Brönstrup, Mark

    2014-01-01

    Covering: up to March 2013. In addition to their prominent role in basic biological and chemical research, natural products are a rich source of commercial products for the pharmaceutical and other industries. Industrial natural product chemistry is of fundamental importance for successful product development, as the vast majority (ca. 80%) of commercial drugs derived from natural products require synthetic efforts, either to enable economical access to bulk material, and/or to optimize drug properties through structural modifications. This review aims to illustrate issues on the pathway from lead to product, and how they have been successfully addressed by modern natural product chemistry. It is focused on natural products of current relevance that are, or are intended to be, used as pharmaceuticals.

  8. Industry Perspectives on Market Access of Innovative Drugs: The Relevance for Oncology Drugs

    PubMed Central

    Pauwels, Kim; Huys, Isabelle; Casteels, Minne; Simoens, Steven

    2016-01-01

    Key Points - Representatives of the pharmaceutical industry call for a broader recognition of value within the assessment and appraisal of innovative drugs- Focus on value within the assessment and appraisal of drugs is jeopardized by financial drives as the side of industry and at the side of the payers- A well–considered value-framework, with attention for patient reported outcomes, societal preferences and dynamic approach on the drug life cycle, needs to be incorporated in assessment and appraisal at national and European level in order to coordinate the views of different stakeholders and allow efficient resource allocation This study presents industry perspectives on the challenges related to market access of innovative drugs in general and oncology drugs in specific. Fifteen interviews were conducted with representatives of pharmaceutical companies and industry associations. Interviewees call for a broader recognition of value within the assessment and appraisal of drugs. According to interviewees, focus on value is jeopardized by the lack of a common value definition across Europe, poor availability and validity of value measures and cost-saving measures such as external reference price setting and cost-effectiveness analysis at the side of the payers. Centralized assessment of relative-effectiveness at European level would provide a common value estimate across member states, independent of financial drivers. Empirical evidence on PRO and societal preferences is however essential in the development of a value definition. Furthermore, value-based pricing would imply a dynamic approach where the price is differentiated across indications and across the lifecycle of the drug, especially in fields such as oncology. Financial drivers however also threat the application of value-based pricing at the side of the industry, making value-based profitability a more appropriate term. PMID:27313529

  9. Industry Perspectives on Market Access of Innovative Drugs: The Relevance for Oncology Drugs.

    PubMed

    Pauwels, Kim; Huys, Isabelle; Casteels, Minne; Simoens, Steven

    2016-01-01

    Key Points - Representatives of the pharmaceutical industry call for a broader recognition of value within the assessment and appraisal of innovative drugs- Focus on value within the assessment and appraisal of drugs is jeopardized by financial drives as the side of industry and at the side of the payers- A well-considered value-framework, with attention for patient reported outcomes, societal preferences and dynamic approach on the drug life cycle, needs to be incorporated in assessment and appraisal at national and European level in order to coordinate the views of different stakeholders and allow efficient resource allocation This study presents industry perspectives on the challenges related to market access of innovative drugs in general and oncology drugs in specific. Fifteen interviews were conducted with representatives of pharmaceutical companies and industry associations. Interviewees call for a broader recognition of value within the assessment and appraisal of drugs. According to interviewees, focus on value is jeopardized by the lack of a common value definition across Europe, poor availability and validity of value measures and cost-saving measures such as external reference price setting and cost-effectiveness analysis at the side of the payers. Centralized assessment of relative-effectiveness at European level would provide a common value estimate across member states, independent of financial drivers. Empirical evidence on PRO and societal preferences is however essential in the development of a value definition. Furthermore, value-based pricing would imply a dynamic approach where the price is differentiated across indications and across the lifecycle of the drug, especially in fields such as oncology. Financial drivers however also threat the application of value-based pricing at the side of the industry, making value-based profitability a more appropriate term.

  10. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Rheumatoid Arthritis... guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.'' This... of patients with rheumatoid arthritis (RA). It also addresses additional considerations for...

  11. An industry statistician's perspective on PHC drug development.

    PubMed

    Fridlyand, Jane; Yeh, Ru-Fang; Mackey, Howard; Bengtsson, Thomas; Delmar, Paul; Spaniolo, Greg; Lieberman, Grazyna

    2013-11-01

    In the past decade, the cost of drug development has increased significantly. The estimates vary widely but frequently quoted numbers are staggering-it takes 10-15 years and billions of dollars to bring a drug to patients. To a large extent this is due to many long, expensive and ultimately unsuccessful drug trials. While one approach to combat the low yield on investment could be to continue searching for new blockbusters, an alternative method would lead us to focus on testing new targeted treatments that have a strong underlying scientific rationale and are more likely to provide enhanced clinical benefit in population subsets defined by molecular diagnostics. Development of these new treatments, however, cannot follow the usual established path; new strategies and approaches are required for the co-development of novel therapeutics and the diagnostic. In this paper we will review, from the point of view of industry, the approaches to, and challenges of drug development strategies incorporating predictive biomarkers into clinical programs. We will outline the basic concepts behind co-development with predictive biomarkers and summarize the current regulatory paradigm. We will present guiding principles of personalized health care (PHC) development and review the statistical, strategic, regulatory and operational challenges that statisticians regularly encounter on development programs with a PHC component. Some practical recommendations for team statisticians involved in PHC drug development are included. The majority of the examples and recommendations are drawn from oncology but broader concepts apply across all therapeutic areas.

  12. 78 FR 4417 - Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Marketing Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry...

  13. 77 FR 11133 - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... Infections: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Complicated Urinary Tract Infections: Developing Drugs for Treatment... treatment of complicated urinary tract infections (cUTIs). Specifically, this guidance addresses...

  14. Alcohol and Drug Prevention Curriculum Resource Guide Grades 10-12: Communication Skills--English IV.

    ERIC Educational Resources Information Center

    North Carolina State Dept. of Public Instruction, Raleigh. Alcohol and Drug Defense Program.

    This curriculum resource guide on alcohol and drug prevention provides suggested activities for teachers of grades 10 through 12. Four integrated learning activities for communication skills/ English IV and healthful living are presented. Communication skills/literature goals include experiencing young adult literature, using effective techniques…

  15. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...: Demonstrating Substantial Equivalence for Tobacco Products.'' In general, the Federal Food, Drug, and...

  16. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic... Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act...

  17. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... six of them from the premarket notification requirements of the Federal Food, Drug, and Cosmetic...

  18. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Federal Food, Drug, and Cosmetic Act (the FD&C Act), procedural information on how to fulfill section...

  19. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... Food, Drug, and Cosmetic Act (FD&C Act), also known as the de novo classification process. FDA...

  20. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft...

  1. Drug-drug interaction studies: regulatory guidance and an industry perspective.

    PubMed

    Prueksaritanont, Thomayant; Chu, Xiaoyan; Gibson, Christopher; Cui, Donghui; Yee, Ka Lai; Ballard, Jeanine; Cabalu, Tamara; Hochman, Jerome

    2013-07-01

    Recently, the US Food and Drug Administration and European Medicines Agency have issued new guidance for industry on drug interaction studies, which outline comprehensive recommendations on a broad range of in vitro and in vivo studies to evaluate drug-drug interaction (DDI) potential. This paper aims to provide an overview of these new recommendations and an in-depth scientifically based perspective on issues surrounding some of the recommended approaches in emerging areas, particularly, transporters and complex DDIs. We present a number of theoretical considerations and several case examples to demonstrate complexities in applying (1) the proposed transporter decision trees and associated criteria for studying a broad spectrum of transporters to derive actionable information and (2) the recommended model-based approaches at an early stage of drug development to prospectively predict DDIs involving time-dependent inhibition and mixed inhibition/induction of drug metabolizing enzymes. We hope to convey the need for conducting DDI studies on a case-by-case basis using a holistic scientifically based interrogative approach and to communicate the need for additional research to fill in knowledge gaps in these areas where the science is rapidly evolving to better ensure the safety and efficacy of new therapeutic agents.

  2. 77 FR 35689 - Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ... Evaluation of Drugs for Treatment; Availability; Correction AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Irritable Bowel Syndrome--Clinical Evaluation of Drugs for...

  3. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...] [FR Doc No: 2011-28766] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De...

  4. Practical English Education for Natural Science and Technology through the Academic-Industrial Cooperation in Gunma University

    NASA Astrophysics Data System (ADS)

    Shinozuka, Kazuo

    English education for specific purpose (ESP) , particularly for the field of natural sciences and technologies, has been attracting great interests in Japan because of the growing demands of the ability to use English in working place to the graduates in the filed. In Gunma University, we have launched a new style of ESP program tilted as “Collaboration between Academic and Industrial Sectors for Practical English Education” as a part of Good Practice Program supported by the Ministry of Education, Culture, Sports, Science, and Technology, Japan (MEXT) since 2006. The program aims to steam up the ability of students to use English through a variety of activities including the presentation of scientific topics in English in a regular class work and the pseudo-conversation (role-playing) style training in a non-regular class work.

  5. 75 FR 47604 - Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Substance Chemistry, Manufacturing, and Controls Information; Availability AGENCY: Food and Drug... availability of a guidance for industry 169 entitled ``Drug Substance Chemistry, Manufacturing, and Controls Information.'' This guidance provides recommendations on the chemistry, manufacturing, and controls...

  6. The role of modern biology and medicine in drug development in academia and industry.

    PubMed

    Blake, Charles A; Barker, Kenneth L; Sobel, Burton E

    2006-12-01

    This symposium addresses careers in drug development in industry; the performance of translational research by academia, industry, and both; and numerous factors pertinent to alliances essential to drug discovery and development. Drug development is a complex process that regularly involves effective collaborations between academic and physician scientists and industry. There are specific occupational factors affecting recruitment of scientists and physicians in drug development programs in industry; ideal backgrounds for successful applicants for positions in industry in drug development; ethical and regulatory considerations particularly germane to the performance of scientists and physicians in drug development programs in industry and at universities; and particular gratifications available to scientists in industry working on drug development. Both similarities and differences characterize the performance of translational research in industry compared with academia. In industry, logistic, operational, and scientific oversight is complex, especially because it often involves relationships with clinical enterprises outside of the corporation. The process is long and arduous from formulation of a good idea in discovery to acceptance of a novel drug in the marketplace. Collaborations and partnerships by industry often involving academia and confrontation of multiple issues are pivotal.

  7. 75 FR 25271 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy Concerning...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-07

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Smokeless Tobacco; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled...

  8. 78 FR 66744 - Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ...: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry entitled ``Pulmonary Tuberculosis: Developing Drugs for Treatment.'' The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of...

  9. 75 FR 63189 - Draft Guidance for Industry on Investigational New Drug Applications-Determining Whether Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  10. 78 FR 72899 - Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act... ``Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food,...

  11. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-20

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... for heart valves. This draft guidance document is not final, nor is it in effect at this time....

  12. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Antibodies to Borrelia Burgdorferi; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft...

  13. 76 FR 27331 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-11

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic Testing; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  14. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance...

  15. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... zonisamide assays. This draft guidance is not final nor is it in effect at this time. DATES: Although you...

  16. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Glucose Suspend Device Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft...

  17. 77 FR 67379 - Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled...

  18. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Helicobacter pylori; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance...

  19. 76 FR 6685 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommended Warning for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... about the potential adverse health effects from the use of powder on medical gloves and is...

  20. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...

  1. 75 FR 73106 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Clostridium difficile; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance...

  2. 76 FR 40921 - Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Radiology Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance...

  3. 76 FR 569 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Staphylococcus aureus; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance...

  4. 75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-27

    ... abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  5. 75 FR 45641 - Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  6. 78 FR 21611 - Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Self-Selection Studies for... entitled ``Self-Selection Studies for Nonprescription Drug Products.'' This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an...

  7. 76 FR 58018 - Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Selection Studies for... entitled ``Self-Selection Studies for Nonprescription Drug Products.'' The draft guidance is intended to provide recommendations to industry on the design of self- selection studies for nonprescription...

  8. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-24

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... the industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are... HUD designations may be eligible for marketing approval under the Humanitarian Device Exemption...

  9. 77 FR 51814 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to... safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User...

  10. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  11. 77 FR 18828 - Guidance for Industry and Food and Drug Administration Staff; Factors To Consider When Making...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... Novo Classifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance document... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration...

  12. 78 FR 54899 - Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug Establishment Registration; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  13. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... HUMAN SERVICES Food and Drug Administration Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  14. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ... HUMAN SERVICES Food and Drug Administration Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  15. The Commissioning and Provision of Advocacy for Problem Drug Users in English DATS: A Cross-Sectional Survey

    ERIC Educational Resources Information Center

    Cargill, Tamsin; Weaver, Tim D.; Patterson, Sue

    2012-01-01

    Aims: This study investigated the commissioning and delivery of advocacy for problem drug users. We aimed to quantify provision, describe the commissioning of advocacy services in Drug Action Teams (DATs) and to identify factors influencing advocacy provision. Methods: A cross-sectional survey of a randomly selected sample of 50 English DATs. The…

  16. 78 FR 31943 - Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ... each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good... for the manufacturing of drugs. This draft guidance is being issued consistent with FDA's good... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Contract...

  17. 75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 2007D-0387) Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies--Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  18. 75 FR 70011 - Guidance for Industry, Mammography Quality Standards Act Inspectors, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-16

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry, Mammography Quality Standards Act Inspectors, and Food and Drug Administration Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 13; Availability AGENCY: Food and Drug...

  19. Drug packaging in 2015: risky industry choices and lax regulation.

    PubMed

    2016-06-01

    Prescrire examined the packaging quality of 240 drugs in 2015. No new advances were identified, but drug packaging continues to expose patients to a variety of dangers. Some past advances persist: for example, INNs are often more legible, and recent patient leaflets tend to be clearer and more informative. But these measures are not applied to all drugs, and are rarely applied retroactively to older drugs. The overall picture in 2015 is that many drugs are difficult to identify, risky or downright dangerous to prepare, or supplied with patient leaflets that fail to correctly inform patients about their medication. And measures to prevent drug poisoning in children need to be completely rethought. It is high time for regulators and policy makers to take the issue of drug packaging seriously, so blatant are the signs of their failure to do so: the increasing use of bulk bottles for new drugs; failure to implement guidelines on safe drug packaging (unit-dose presentations, appropriate dosing devices, etc.); and expanding umbrella brands which, given the dangers they pose to patients, should be banned instead. All things considered, healthcare professionals and patients must remain vigilant and report any dangers they identify. A major European initiative on drug packaging is becoming increasingly necessary.

  20. 78 FR 49529 - Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-14

    ... Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability... ``Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug... Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff,'' you may...

  1. Natural products and drug discovery: a survey of stakeholders in industry and academia

    PubMed Central

    Amirkia, Vafa; Heinrich, Michael

    2015-01-01

    Context: In recent decades, natural products have undisputedly played a leading role in the development of novel medicines. Yet, trends in the pharmaceutical industry at the level of research investments indicate that natural product research is neither prioritized nor perceived as fruitful in drug discovery programmes as compared with incremental structural modifications and large volume HTS screening of synthetics. Aim: We seek to understand this phenomenon through insights from highly experienced natural product experts in industry and academia. Method: We conducted a survey including a series of qualitative and quantitative questions related to current insights and prospective developments in natural product drug development. The survey was completed by a cross-section of 52 respondents in industry and academia. Results: One recurrent theme is the dissonance between the perceived high potential of NP as drug leads among individuals and the survey participants' assessment of the overall industry and/or company level strategies and their success. The study's industry and academic respondents did not perceive current discovery efforts as more effective as compared with previous decades, yet industry contacts perceived higher hit rates in HTS efforts as compared with academic respondents. Surprisingly, many industry contacts were highly critical to prevalent company and industry-wide drug discovery strategies indicating a high level of dissatisfaction within the industry. Conclusions: These findings support the notion that there is an increasing gap in perception between the effectiveness of well established, commercially widespread drug discovery strategies between those working in industry and academic experts. This research seeks to shed light on this gap and aid in furthering natural product discovery endeavors through an analysis of current bottlenecks in industry drug discovery programmes. PMID:26578954

  2. Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective.

    PubMed

    Jones, H M; Chen, Y; Gibson, C; Heimbach, T; Parrott, N; Peters, S A; Snoeys, J; Upreti, V V; Zheng, M; Hall, S D

    2015-03-01

    The application of physiologically based pharmacokinetic (PBPK) modeling has developed rapidly within the pharmaceutical industry and is becoming an integral part of drug discovery and development. In this study, we provide a cross pharmaceutical industry position on "how PBPK modeling can be applied in industry" focusing on the strategies for application of PBPK at different stages, an associated perspective on the confidence and challenges, as well as guidance on interacting with regulatory agencies and internal best practices.

  3. Recreational drug use within the employees of the mariculture and seafood industry in South Australia.

    PubMed

    Evans, Alan R; Tait, Russell; Harvey, Peter; Newbury, Jonathan

    2005-01-01

    A study of recreational drug use among workers in the Port Lincoln mariculture and seafood industries was conducted by self report questionnaire. High rates of cannabis and alcohol use were revealed during the shore based fish farming season. The occupational health and safety implications of these findings in one of Australia's most dangerous industries are significant. Further research could inform the development of industry specific harm minimisation policies.

  4. Co-operation between patient organisations and the drug industry in Finland.

    PubMed

    Hemminki, Elina; Toiviainen, Hanna K; Vuorenkoski, Lauri

    2010-04-01

    The aim of the study was to investigate the co-operation between patient organizations and the drug industry in Finland prior to critical discussions on the topic. The data were gathered by a questionnaire survey of 85 patient organisations (response rate 65%, n = 55) and 20 drug firms (response rate 100%) in 2003, and by interviewing 13 organisations and surveying their web-pages and other documents in 2004. In the surveys, half of the patient organisations and 80% of the drug firms considered co-operation important. Most (71%) organisations reported financial support from the drug industry. Most organisations and drug firms had experienced problems. Common problems for organisations were too little or too unpredictable support from industry, and threats to independence and objectivity. Drug firms frequently mentioned unclear rules of co-operation. The patient organisation interviews exhibited similar themes and findings to those found in the surveys, revealing the complexity and importance of co-operation in organisation activities, and the variation between organisations. This case study from Finland showed that co-operation between patient organizations and the drug industry was common, many-sided and not usually transparent. The close connections between patient organizations and commercial companies, particularly drug firms, raise several policy issues and the need for action.

  5. 77 FR 60126 - Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ...; Formerly 2008N-0004] Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment... Media: Developing Drugs for Treatment.'' This guidance addresses FDA's current thinking regarding the... treatment of acute bacterial otitis media (ABOM). This guidance finalizes the revised draft guidance of...

  6. 76 FR 55927 - Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked... the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.''...

  7. Drug-drug interactions related to altered absorption and plasma protein binding: theoretical and regulatory considerations, and an industry perspective.

    PubMed

    Hochman, Jerome; Tang, Cuyue; Prueksaritanont, Thomayant

    2015-03-01

    Drug-drug interactions (DDIs) related to altered drug absorption and plasma protein binding have received much less attention from regulatory agencies relative to DDIs mediated via drug metabolizing enzymes and transporters. In this review, a number of theoretical bases and regulatory framework are presented for these DDI aspects. Also presented is an industry perspective on how to approach these issues in support of drug development. Overall, with the exception of highly permeable and highly soluble (BCS 1) drugs, DDIs related to drug-induced changes in gastrointestinal (GI) physiology can be substantial, thus warranting more attentions. For a better understanding of absorption-associated DDI potential in a clinical setting, mechanistic studies should be conducted based on holistic integration of the pharmaceutical profiles (e.g., pH-dependent solubility) and pharmacological properties (e.g., GI physiology and therapeutic margin) of drug candidates. Although majority of DDI events related to altered plasma protein binding are not expected to be of clinical significance, exceptions exist for a subset of compounds with certain pharmacokinetic and pharmacological properties. Knowledge of the identity of binding proteins and the binding extent in various clinical setting (including disease states) can be valuable in aiding clinical DDI data interpretations, and ensuring safe and effective use of new drugs.

  8. Toward allocative efficiency in the prescription drug industry.

    PubMed

    Guell, R C; Fischbaum, M

    1995-01-01

    Traditionally, monopoly power in the pharmaceutical industry has been measured by profits. An alternative method estimates the deadweight loss of consumer surplus associated with the exercise of monopoly power. Although upper and lower bound estimates for this inefficiency are far apart, they at least suggest a dramatically greater welfare loss than measures of industry profitability would imply. A proposed system would have the U.S. government employing its power of eminent domain to "take" and distribute pharmaceutical patents, providing as "just compensation" the present value of the patent's expected future monopoly profits. Given the allocative inefficiency of raising taxes to pay for the program, the impact of the proposal on allocative efficiency would be at least as good at our lower bound estimate of monopoly costs while substantially improving efficiency at or near our upper bound estimate.

  9. 76 FR 44594 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...'s good guidance practices. DATES: Submit either electronic or written comments on this guidance...

  10. 75 FR 15440 - Guidance for Industry on Standards for Securing the Drug Supply Chain-Standardized Numerical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  11. 75 FR 69449 - Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-12

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... manufacturer or distributor of a human drug or biologic, or from FDA--intended to alert physicians and...

  12. 76 FR 22903 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Request AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... February 15, 2007'' to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate...

  13. 76 FR 36543 - Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to...

  14. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... regulations issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) relating to tobacco products...

  15. Is the term substitution relevant to Pharmacognosy and/ or vegetable crude drug industry?

    PubMed

    Selvam, A B D

    2010-09-01

    Since each and every drug plant has its own characteristic features, in terms of its botanical characters, chemical composition and therapeutic properties, considering the highly potential drug plants as genuine plant and less potential (allied or non-allied) drug plants as substitutes is unjustifiable. Moreover, the term Substitution is being used for a couple of centuries in a wrong sense in pharmacognostic studies or in the vegetable crude drug industry. Therefore, the term 'Substitution' has to be replaced by the relevant and appropriate term, 'Alternative' or 'Alternative source'.

  16. 78 FR 63220 - Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Acute Bacterial Skin and Skin... guidance for industry entitled ``Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for... drugs to treat acute bacterial skin and skin structure infections (ABSSSI). This guidance finalizes...

  17. 78 FR 22887 - Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-17

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A... announcing the availability of a guidance for industry entitled ``Non-Penicillin Beta- Lactam Drugs: A CGMP... (APIs) with non-penicillin beta-lactams. This guidance also provides information regarding the...

  18. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Solvents in Animal... guidance for industry 211 entitled ``Residual Solvents in Animal Drug Products; Questions and Answers... Chapter Residual Solvents that applies to both human and veterinary drugs and to compendial and...

  19. Peering into the pharmaceutical "pipeline": investigational drugs, clinical trials, and industry priorities.

    PubMed

    Fisher, Jill A; Cottingham, Marci D; Kalbaugh, Corey A

    2015-04-01

    In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry's investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding--and often problematic--role of pharmaceuticals in society. To access the pharmaceutical industry's pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2477 different drugs in 4182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline was being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered.

  20. Barriers to Alzheimer disease drug discovery and development in the biotechnology industry.

    PubMed

    Altstiel, L D

    2002-01-01

    The major barrier to Alzheimer disease (AD) drug discovery and development in the biotechnology industry is scale. Most biotechnology companies do not have the personnel or expertise to carry a drug from the bench to the market. Much effort in the industry has been directed toward the elucidation of molecular mechanisms of AD and the identification of new targets. Advances in biotechnology have generated new insights into disease mechanisms, increased the number of lead compounds, and accelerated biologic screening. The majority of costs associated with drug development are in clinical testing and development activities, many of which are driven by regulatory issues. For most biotechnology companies, the costs of such trials and the infrastructure necessary to support them are prohibitive. Another significant barrier is the definition of therapeutic benefit for AD drugs; Food and Drug Administration (FDA) precedent has established that a drug must show superiority to placebo on a performance-based test of cognition and a measure of global clinical function. This restrictive definition is biased toward drugs that enhance performance on memory-based tests. Newer AD drugs are targeted toward slowing disease progression; however, there is currently no accepted definition of what constitutes efficacy in disease progression. Despite these obstacles, the biotechnology industry has much to offer AD drug discovery and development. Biotechnology firms have already developed essential technology for AD drug development and will continue to do so. Biotechnology companies can move more quickly; of course, the trick is to move quickly in the right direction. Speed may offset some of the problems associated with lack of scale. Additionally, biotechnology companies can afford to address markets that may be too restricted for larger pharmaceutical companies. This advantage will have increasing importance, as therapies are developed to address subtypes of AD.

  1. Drug and alcohol abuse: the bases for employee assistance programs in the nuclear-utility industry

    SciTech Connect

    Radford, L.R.; Rankin, W.L.; Barnes, V.; McGuire, M.V.; Hope, A.M.

    1983-07-01

    This report describes the nature, prevalence, and trends of drug and alcohol abuse among members of the US adult population and among personnel in non-nuclear industries. Analogous data specific to the nuclear utility industry are not available, so these data were gathered in order to provide a basis for regulatory planning. The nature, prevalence, and trend inforamtion was gathered using a computerized literature, telephone discussions with experts, and interviews with employee assistance program representatives from the Seattle area. This report also evaluates the possible impacts that drugs and alcohol might have on nuclear-related job performance, based on currently available nuclear utility job descriptions and on the scientific literature regarding the impairing effects of drugs and alcohol on human performance. Employee assistance programs, which can be used to minimize or eliminate job performance decrements resulting from drug or alcohol abuse, are also discussed.

  2. [PHARMACEUTICAL INDUSTRY AND PERSONALIZED MEDICINE: A PARADIGM SHIFT IN THE DEVELOPMENT OF NEW DRUGS].

    PubMed

    Scheen, A J

    2015-01-01

    The cost of pharmacotherapy is increasing in the health care budget. The pharmaceutical industry is facing the exhaustion of medications that are largely prescribed and have a high profitability (blockbusters). Because of patient heterogeneity, there is a great interindividual variability of the responses to drug therapy. Thus, it is essential to better detect potential to avoid waste of resources resulting from the prescription of expensive drugs to poor responders. The development of personalized medicine, or precision medicine, certainly offers opportunities to the pharmaceutical industry, but also exposes it to new big challenges.

  3. Industry invites regulation: the passage of the Pure Food and Drug Act of 1906.

    PubMed Central

    Barkan, I D

    1985-01-01

    Ending its 27-year stranglehold on proposals for federal pure food and drug legislation, Congress passed the Pure Food and Drug Act and its companion bill, the Meat Inspection Act, on June 30, 1906. An unprecedented convergence of consumer, scientific, and industrial support in 1906 prompted such action; most industries even planned for it, hoping regulation would restore the competitiveness of their products on weak foreign and domestic markets. The ways in which these interests converged, and the reasons therefore, suggest a change in their relationships to each other and with the federal government as America headed into the twentieth century. Images p21-a p21-b PMID:3881052

  4. Regulating drug information in Europe: a pyrrhic victory for pharmaceutical industry critics?

    PubMed

    Mulinari, Shai

    2013-06-01

    Informed by recent sociological debates on pharmaceuticalisation, this article examines the evolution of the current EU legal proposal on prescription drug information to patients, as well as the surrounding controversies. In 2008 the European Commission proposed the relaxation of the existing rules governing drug information provision to patients by the pharmaceutical industry. Critics of the industry's influence over health policy and markets, including consumer organisations, industry-independent patient organisations and health professionals, rejected the Commission's proposal, claiming that the industry cannot be considered a reliable source of patient information due to inherent financial conflicts of interest. Since these critics were at least partially successful in rallying opinion against the Commission proposal, they functioned as countervailing forces to promotion-driven pharmaceuticalisation. Even so, as a watered-down version of the proposal moved through the European Parliament it was further modified to ultimately resemble the Swedish system that was held up as a high-quality example of industry-based information provision. Yet this article contends that the Swedish system displays evidence of corporate bias. Significantly, basing EU policy on a drug information system not resistant to corporate bias risks creating practices that violate the legally mandated mission of EU drug regulation, which is to 'promote and protect public health'.

  5. Petroleum Refining, Industrial Chemical, Drug, and Paper and Allied Products Industries. Reprinted from the Occupational Outlook Handbook, 1978-79 Edition.

    ERIC Educational Resources Information Center

    Bureau of Labor Statistics (DOL), Washington, DC.

    Focusing on occupations in refining and industrial chemical, drug, and paper manufacturing industries, this document is one in a series of forty-one reprints from the Occupational Outlook Handbook providing current information and employment projections for individual occupations and industries through 1985. The specific occupations covered in…

  6. 75 FR 73108 - Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... degradation products and updates the draft guidance ``ANDAs: Impurities in Drug Products'' announced in... final guidance to: (1) Update information on listing of degradation products, setting acceptance criteria, and qualifying degradation products (thresholds and procedures) in abbreviated new...

  7. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... for the Topical Approximation of Skin; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...

  8. 76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-14

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... subject to comment in accordance with the Agency's good guidance practices. DATES: Submit...

  9. 76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... subject to comment in accordance with the Agency's good guidance practices. DATES: Submit...

  10. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  11. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  12. 77 FR 32124 - Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... Evaluation of Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment.'' This guidance is intended to assist the pharmaceutical industry and investigators who are developing drugs for the...

  13. 78 FR 38058 - Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  14. 78 FR 60292 - Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Application Submissions--Refuse-to-Receive Standards; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  15. 76 FR 64228 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  16. 76 FR 44935 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ...] [FR Doc No: 2011-18923] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0453] Draft Guidance for Industry and Food and Drug Administration Staff; 510(k... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration...

  17. 76 FR 20688 - Guidance for Industry and Food and Drug Administration Staff; 30-Day Notices, 135-Day Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Supplements for Manufacturing Method or Process Changes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  18. 76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... document is immediately in effect as the special control for the ovarian adnexal mass assessment score...

  19. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ...] [FR Doc No: 2012-15025] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  20. 75 FR 21632 - Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... safety and effectiveness of these devices. This draft guidance is not final nor is it in effect at...

  1. 77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on...

  2. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing... adequately addressed in clinical trials. This draft guidance is not final nor is it in effect at this...

  3. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Assays; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class...

  4. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  5. 76 FR 20689 - Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  6. 78 FR 38349 - Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  7. English Teaching Profile: Bahrain

    ERIC Educational Resources Information Center

    British Council, London (England). English Language and Literature Div.

    A profile of the state of English and English instruction in Bahrain covers the following topics: description of the role and status of English language use in industry and commerce, government, and education; the role of English at all levels of the educational system; the availability, characteristics, and qualifications of teachers of English;…

  8. Survey of industry and government programs to combat drug and alcohol abuse

    SciTech Connect

    Altman, W.; Brown, W.; Bush, L.; Cobb, L.I.

    1982-06-01

    The results of a Task Force survey of the drug and alcohol programs of ten licensed nuclear utilities, of two federal agencies, and of two large corporations not in the nuclear industry are described. The Task Force solicited, and reports on, utility management views on the extent of the drug and alcohol problem, company policies on the work-related use or possession of alcohol or drugs, and utility management views on proposed regulatory initiatives which would address the drug and alcohol question. The report also describes utility practice and perceptions on: the use of background investigations, psychological tests, supervisory training and behavioral observation, employee awareness programs, employee assistance and rehabilitation programs, and the use of chemical tests and other measures to detect drug and/or alcohol use. Nonnuclear programs reported on are: Department of Defense, Federal Aviation Administration, Kimberly-Clark Corporation, and General Motors Corporation. The Task Force's survey was limited generally to better drug and alcohol programs and discussions with corporate officials. The schedule for the survey did not permit the gathering of supporting data to determine the quantitative effectiveness of the programs reported on, or of drug and alcohol programs of the nuclear industry in general.

  9. Perception of various stakeholders regarding clinical drug trial industry in India

    PubMed Central

    Parikh, Rakesh M.; Pandia, Kirti; Goyal, Mahesh; Sharma, Meenakshi; Dolima, M. S.

    2011-01-01

    Context: Though India has been thought to be an ideal destination for conduct of clinical drug trials, other smaller countries seem to be doing better. The pace of growth observed during 2005-2009 seems to be plateaued in 2010. Aims: There is an urgent need for introspection and corrective actions. Materials and Methods: An online survey was conducted among various stakeholders from clinical drug trial industry in India regarding their perception about clinical drug trial industry in India. Respondents were requested to rate training of investigator sites, industry, performance of regulatory, etc. Results: Majority of respondent felt that the clinical drug trial industry in India is growing, though India is not utilizing its full potential. Lack of trained investigators and delay in regulatory approvals came out as biggest hurdles. Conclusions: Urgent steps need to be taken in terms of proper training of all stakeholders. Regulatory bodies ought to bring about some radical changes in the system so as to match the other competing nations. PMID:21897882

  10. 76 FR 41803 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-15

    ... Differentiation of Influenza Viruses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Differentiation of Influenza Viruses.'' FDA is issuing this guidance to inform industry and Agency staff of its... diagnostic devices intended for the detection or detection and differentiation of influenza viruses....

  11. Web Based Projects Enhancing English Language and Generic Skills Development for Asian Hospitality Industry Students

    ERIC Educational Resources Information Center

    Wang, Mei-jung

    2009-01-01

    This study investigated hospitality students' responses toward their learning experiences from undertaking group projects based upon a College web platform, the "Ubiquitous Hospitality English Learning Platform" (U-HELP). Twenty-six students in the Department of Applied Foreign Languages participated in this study. Their attitudes toward…

  12. The politics of access to expensive drugs: INESSS and the innovative pharmaceutical industry.

    PubMed

    Hughes, David

    2012-05-01

    The innovative pharmaceutical industry employs thousands of people in Quebec and so has the ability to exert strong political pressure; the public statements of Sanofi-Aventis concerning the provincial reimbursement of certain expensive drugs are an example. "Maintaining a dynamic biopharmaceutical industry" is one of four main axes of the drug policy of Quebec's ministry of health. However, this role of government should not take precedence over the efficient and equitable management of health resources. We defend the legitimate and responsible choice of the Institut national d'excellence en santé et en services sociaux du Québec (INESSS) to require an acceptable cost-effectiveness ratio from expensive new drugs.

  13. Innovator Organizations in New Drug Development: Assessing the Sustainability of the Biopharmaceutical Industry.

    PubMed

    Kinch, Michael S; Moore, Ryan

    2016-06-23

    The way new medicines are discovered and brought to market has fundamentally changed over the last 30 years. Our previous analysis showed that biotechnology companies had contributed significantly to the US Food and Drug Administration approval of new molecular entities up to the mid-1980s, when the trends started to decline. Although intriguing, the focus on biotechnology necessarily precluded the wider question of how the biopharmaceutical industry has been delivering on its goals to develop new drugs. Here, we present a comprehensive analysis of all biopharmaceutical innovators and uncover unexpected findings. The present biopharmaceutical industry grew steadily from 1800 to 1950 and then stagnated for two decades, before a burst of growth attributable to the biotechnology revolution took place; but consolidation has reduced the number of active and independent innovators to a level not experienced since 1945. The trajectories and trends we observe raise fundamental questions about biopharmaceutical innovators and the sustainability of the drug-development enterprise.

  14. 76 FR 46303 - Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

    .... We acknowledge that there will be cord blood banks that are not able to achieve licensure by October... Blood Intended for Hematopoietic Reconstitution for Specified Indications; Availability AGENCY: Food and... Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord...

  15. The teaching of drug development to medical students: collaboration between the pharmaceutical industry and medical school

    PubMed Central

    Stanley, A G; Jackson, D; Barnett, D B

    2005-01-01

    Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK. PMID:15801942

  16. 77 FR 57094 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of... announced a draft guidance for industry entitled ``Self-Identification of Generic Drug Facilities,...

  17. 76 FR 25696 - Guidance for Industry on Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-05

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Dosage Delivery Devices for Orally.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... intended to provide guidance to firms that are manufacturing, marketing, or distributing orally...

  18. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... guidance for industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are... HUD designation may be eligible for marketing approval under the Humanitarian Device Exemption...

  19. 78 FR 9396 - Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Alzheimer's Disease... a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of... demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer's disease that...

  20. Oversight of marketing relationships between physicians and the drug and device industry: a comparative study.

    PubMed

    Jost, Timothy Stoltzfus

    2010-01-01

    Throughout the world, complex mutually-dependent relationships exist between physicians and pharmaceutical and medical device companies. This article focuses on one particular aspect of these relationships-payments made by drug and device companies to physicians and their organizations and institutions to market drugs and devices. It is widely believed that drug and device company marketing to physicians creates conflicts of interest that corrupt physician judgment and increase the cost of medical care. This article examines first the economic basis of physician/industry relationships that causes conflicts to arise. It next considers the measures that a number of developed countries have taken to respond to these relationships. Finally, it proposes an approach that would comprehensively address the problems caused by drug and device company marketing to physicians.

  1. English Communicative Events and Skills Needed at the Workplace: Feedback from the Industry

    ERIC Educational Resources Information Center

    Kassim, Hafizoah; Ali, Fatimah

    2010-01-01

    The constant and continuous need for the university to work towards producing graduates who meet and exceed the requirements of their chosen industry has prompted the effort to gather feedback from those industries. The effort by researchers of an engineering-based university in the East Coast Region of Malaysia to collect information on the…

  2. Nanotechnology-based drug delivery systems for Alzheimer's disease management: Technical, industrial, and clinical challenges.

    PubMed

    Wen, Ming Ming; El-Salamouni, Noha S; El-Refaie, Wessam M; Hazzah, Heba A; Ali, Mai M; Tosi, Giovanni; Farid, Ragwa M; Blanco-Prieto, Maria J; Billa, Nashiru; Hanafy, Amira S

    2017-01-10

    Alzheimer's disease (AD) is a neurodegenerative disease with high prevalence in the rapidly growing elderly population in the developing world. The currently FDA approved drugs for the management of symptomatology of AD are marketed mainly as conventional oral medications. Due to their gastrointestinal side effects and lack of brain targeting, these drugs and dosage regiments hinder patient compliance and lead to treatment discontinuation. Nanotechnology-based drug delivery systems (NTDDS) administered by different routes can be considered as promising tools to improve patient compliance and achieve better therapeutic outcomes. Despite extensive research, literature screening revealed that clinical activities involving NTDDS application in research for AD are lagging compared to NTDDS for other diseases such as cancers. The industrial perspectives, processability, and cost/benefit ratio of using NTDDS for AD treatment are usually overlooked. Moreover, active and passive immunization against AD are by far the mostly studied alternative AD therapies because conventional oral drug therapy is not yielding satisfactorily results. NTDDS of approved drugs appear promising to transform this research from 'paper to clinic' and raise hope for AD sufferers and their caretakers. This review summarizes the recent studies conducted on NTDDS for AD treatment, with a primary focus on the industrial perspectives and processability. Additionally, it highlights the ongoing clinical trials for AD management.

  3. SPECIAL ENGLISH.

    ERIC Educational Resources Information Center

    English Language Services, Inc., Washington, DC.

    THIS 14-VOLUME SERIES OF TECHNICAL ENGLISH TEXTS IS DESIGNED TO PROVIDE PRACTICE IN TECHNICAL TERMINOLOGY FOR NON-NATIVE SPEAKERS OF ENGLISH. LANGUAGE FLUENCY LEVEL IS UPPER-INTERMEDIATE/ADVANCED. THE VARIOUS FIELDS OF INDUSTRY WHICH THE TEXTS DEAL WITH ARE AS FOLLOWS--(1) AGRICULTURE--BOOK 1, SOILS (2) AGRICULTURE--BOOK 2, FIELD CROPS (3)…

  4. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of... written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630... enhancements to FDA's generic drugs program. GDUFA will also significantly improve global supply...

  5. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ... HUMAN SERVICES Food and Drug Administration (Formerly Docket No. 2006D-0344) Draft Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling... entitled ``Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and...

  6. 77 FR 14811 - Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Direct-to-Consumer Television Advertisements--the Food and Drug Administration Amendments Act of 2007 Direct-to-Consumer Television Ad Pre-Dissemination Review Program; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice....

  7. 75 FR 14602 - Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Opening of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. FDA-2008-D-0128) Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Opening of Comment Period for Future Revision of Guidance Dated July 2009; Public Conference AGENCY: Food and Drug Administration, HHS....

  8. 76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-18

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...

  9. 76 FR 50483 - Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  10. Living above the shop: home, business, and family in the English "Industrial Revolution".

    PubMed

    Barker, Hannah; Hamlett, Jane

    2010-01-01

    This article explores the living arrangements and familial relations of small business households in northwest English towns between 1760 and 1820. Focusing on evidence from inventories and personal writing, it examines the homes that such households lived and worked in and the ways in which space was ordered and used: indicating that access to particular spaces was determined by status. This study suggests both the continuance of the "household family" into the nineteenth century (rather than its more modern, "nuclear" variant) and the existence of keenly felt gradations of status within households making it likely that the constitution of "the family" differed according to one's place in the domestic hierarchy.

  11. Lowering industry firewalls: pre-competitive informatics initiatives in drug discovery.

    PubMed

    Barnes, Michael R; Harland, Lee; Foord, Steven M; Hall, Matthew D; Dix, Ian; Thomas, Scott; Williams-Jones, Bryn I; Brouwer, Cory R

    2009-09-01

    Pharmaceutical research and development is facing substantial challenges that have prompted the industry to shift funding from early- to late-stage projects. Among the effects is a major change in the attitude of many companies to their internal bioinformatics resources: the focus has moved from the vigorous pursuit of intellectual property towards exploration of pre-competitive cross-industry collaborations and engagement with the public domain. High-quality, open and accessible data are the foundation of pre-competitive research, and strong public-private partnerships have considerable potential to enhance public data resources, which would benefit everyone engaged in drug discovery. In this article, we discuss the background to these changes and propose new areas of collaboration in computational biology and chemistry between the public domain and the pharmaceutical industry.

  12. Illicit Drug and Injecting Equipment Markets inside English Prisons: A Qualitative Study

    ERIC Educational Resources Information Center

    Hughes, Rhidian

    2003-01-01

    In recent years, disrupting the supply of illicit drugs and injecting equipment inside Her Majesty's (HM) prisons has become an important focus for prison drug policy. This paper presents findings from qualitative research, which invited 24 drug injectors with prison experience to discuss the role and operation of illicit drug and injecting…

  13. The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy

    PubMed Central

    Löfgren, Hans

    2007-01-01

    This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products. PMID:17543115

  14. Mixing drink and drugs: 'Underclass' politics, the recovery agenda and the partial convergence of English alcohol and drugs policy.

    PubMed

    Monaghan, Mark; Yeomans, Henry

    2016-11-01

    Alcohol policy and illicit drugs policy are typically presented as separate and different in academic discussion. This is understandable, to a degree, as the criminal law upholds a 'great regulatory divide' (Seddon, 2010: 56) separating the licit trade in alcohol from the illicit trade in substances classified as either class A, B or C under the Misuse of Drugs Act 1971. This paper takes a different stance. In doing so, it draws upon Berridge's (2013) argument that policies governing various psychoactive substances have been converging since the mid-twentieth century and seeks to elaborate it using recent developments relating to the control and regulation of drugs and alcohol in the broader areas of criminal justice and welfare reform. Significantly, the article examines how recent policy directions relating to both drugs and alcohol in England have, under the aegis of the 'recovery agenda', been connected to a broader behavioural politics oriented towards the actions and lifestyles of an apparently problematic subgroup of the population or 'underclass'. The paper thus concludes that, although the great regulatory divide remains intact, an underclass politics is contributing towards the greater alignment of illicit drugs and alcohol policies, especially in regards to the respective significance of abstinence (or abstinence-based 'recovery').

  15. The Impact of Chemical Probes in Drug Discovery: A Pharmaceutical Industry Perspective.

    PubMed

    Garbaccio, Robert M; Parmee, Emma R

    2016-01-21

    Chemical probes represent an important component of both academic and pharmaceutical drug discovery research. As a complement to prior reviews that have defined this scientific field, we aim to provide an industry perspective on the value of having high-quality chemical probes throughout the course of preclinical research. By studying examples from the internal Merck pipeline, we recognize that these probes require significant collaborative investment to realize their potential impact in clarifying the tractability and translation of a given therapeutic target. This perspective concludes with recommendations for chemical probe discovery aimed toward maximizing their potential to identify targets that result in the successful delivery of novel therapeutics.

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

    PubMed

    Cosgrove, Lisa; Vannoy, Steven; Mintzes, Barbara; Shaughnessy, Allen F

    2016-01-01

    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.

  17. 77 FR 11550 - Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Notification to Food and Drug..., directing FDA to use all available administrative tools to expand the Agency's efforts to combat the problem... required nutrition, or to address other serious medical conditions. Other shortages force providers...

  18. 77 FR 20825 - Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ...; User Fees for 513(g) Requests for Information; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information.'' This guidance document describes the user fees associated with 513(g)...

  19. Controversies in drug and industry--its measures: a view point.

    PubMed

    Narayana, A

    2003-01-01

    Man has been fascinated by nature since he evolved from his primitive ancestors, the apes. No doubt to start with, he hunted for food mainly by killing the wild animals, but if there was anything on which he could depend upon with any confidence towards its availability, it was the plant. Not only the fact that a large number of plants provided him with food but also the fact that they provided him with curative medicine and shelter, were perhaps the reasons why he worshiped them more than the animals which also gave him food. There are a large number of plants, which are used by the people all over India for curse against witchcraft or to remove the effect of the evil eye and sickness. The use of the flora in India to relieve mankind from their sufferings was known from the ancient days. This includes all food, fuel, shelter, drugs, cosmetics etc. The standards have been maintained for several centuries since the disciples were trained in the forest close to the natural flora. In the present paper certain useful methodologies are evaluated for preparing standard Herbal formulations and focus mainly on two things namely drug (Dravya) and industry (pharmaceutical industry).

  20. The changing environment of graduate and postdoctoral training in drug metabolism: viewpoints from academia, industry, and government.

    PubMed

    Stevens, Jeffrey C; Dean, Dennis C; Preusch, Peter C; Correia, Maria Almira

    2003-04-01

    This article is an invited report of a symposium sponsored by the Drug Metabolism Division of the American Society for Pharmacology and Experimental Therapeutics held at Experimental Biology 2002 in New Orleans. The impetus for the symposium was a perceived shortage in the supply of graduate students qualified for drug metabolism research positions in industry, academia, and government. For industry, recent hiring stems largely from the expansion of drug metabolism departments in an effort to keep pace with the demands of drug discovery and new technologies. In turn, regulatory scientists are needed to review and verify the results of the increased number and volume of studies required for drug development and approval. Thus the initial source of training, academia, has been forced to recognize these external hiring pressures while trying to attract and retain the faculty, postdoctoral scientists, and students necessary for active teaching and research programs. The trend of the expansion of the interdisciplinary nature of traditional drug metabolism to include emerging technologies such as pharmacogenetics, transporters, and proteomics and the implications for future needs in training and funding were acknowledged. There was also consensus on the value of partnerships between academia and industry for increasing student interest and providing training in disciplines directly applicable to industrial drug metabolism research. Factors affecting the sources of these trainees, such as federal funding, the number of trainees per institution, and recent issues with immigration restrictions that have limited the flow of scientists were also discussed.

  1. Lexis in Chinese-English Translation of Drug Package Inserts: Corpus-based Error Analysis and Its Translation Strategies.

    PubMed

    Ying, Lin; Yumei, Zhou

    2010-12-01

    Error analysis (EA) has been broadly applied to the researches of writing, speaking, second language acquisition (SLA) and translation. This study was carried out based on Carl James' error taxonomy to investigate the distribution of lexical errors in Chinese-English (C-E) translation of drug package inserts (DPIs)(1), explore the underlying causes and propose some translation strategies for correction and reduction of lexical errors in DPIs. A translation corpus consisting of 25 DPIs translated from Chinese into English was established. Lexical errors in the corpus and the error causes were analyzed qualitatively and quantitatively. Some examples were used to analyze the lexical errors and their causes, and some strategies for translating vocabulary in DPIs were proposed according to Eugene Nida's translation theory. This study will not only help translators and medical workers reduce errors in C-E translation of vocabulary in DPIs and other types of medical texts but also shed light on the learning and teaching of C-E translation of medical texts.

  2. 75 FR 45130 - Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... Drug Research Committee: Human Research Without an Investigational New Drug Application; Availability... Drug Research Committee: Human Research Without an Investigational New Drug Application.'' This... committee, or ] whether research studies must be conducted under an investigational new drug...

  3. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS... Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act.'' This... Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act'' to the...

  4. Productive university, industry, and government relationships in preclinical drug discovery and development: considerations toward a synergistic lingua franca.

    PubMed

    Janero, David R

    2012-06-01

    Efficiency and productivity shortfalls conspire with subpar economic return to stigmatize the pharmaceutical industry and jeopardize its viability. This complex and costly innovation-to-commercialization failure, the formidable associated costs, and the relevance of various core competencies endemic to universities, the pharmaceutical industry, and government have been major drivers for establishing preclinical drug-discovery alliances involving these constituencies. Such cross-sector alliances have the potential to help restore at least some of the industry's former health by militating risk, enhancing productivity, and improving the quantity/quality of development candidates. This Editorial will highlight certain characteristics of pharma-industry and non-industrial settings that can jeopardize the effectiveness of these sectors for unified preclinical discovery campaigns capable of generating well-characterized drug candidates that merit human testing. Based on decades of research and development (R&D) and business experience spanning international big-pharma, biotechnology, and academic spheres, the author opines that a synergistic lingua franca is required among involved constituencies in order for such cross-sector discovery alliances to emerge as robust drug-discovery engines fueled by joint intellectual effort. Technology-transfer professionals, postdoctoral trainees, and consultants are discussed as resources for helping establish the university-industry-government triumvirate as a normative innovation network for preclinical drug discovery and development in the 21st century.

  5. Project VOICE (Vocational Occupations for Industrial Communications English): A Competency Based Education Curriculum for the Limited English Proficient in Building Maintenance.

    ERIC Educational Resources Information Center

    Chaloupka, Diana; Papierniak, Kathleen, Ed.

    Developed for vocational educators of short-term or long-term programs, this manual presents a complete competency-based curriculum in building maintenance for the advanced limited English proficient student. Following instructions on use of the manual and recommended references, a student tracking system and record sheet are provided, which list…

  6. Designing Email Tasks for the Business English Classroom: Implications from a Study of Hong Kong's Key Industries

    ERIC Educational Resources Information Center

    Evans, Stephen

    2012-01-01

    Email has revolutionised the way in which professionals work and companies operate, and yet has received surprisingly little scholarly attention in English for Specific Purposes and has an unexpectedly muted presence in many Business English textbooks. The dearth of research into email use in globalised business settings may be one of the factors…

  7. Advanced English as a Second Language for Manufacturing. P.R.I.D.E. People Retraining for Industry Excellence.

    ERIC Educational Resources Information Center

    Lewandowski, Carol

    This workplace skills training course in English as a Second Language (ESL) identifies English problems for nonnative speakers and encourages students to practice speaking, writing, listening, and reading skills using company literature. Introductory material includes course description, objectives, topical outline, and evaluation. The course…

  8. English as a Second Language in the Workplace. P.R.I.D.E. People Retraining for Industry Excellence.

    ERIC Educational Resources Information Center

    Lewandowski, Carol

    This workplace skills course in English as a Second Language in the workplace identifies English problems for non-native speakers and encourages students to practice speaking, writing, listening, and reading skills using company literature such as procedures, lists, policies, and safety information. Introductory material includes pre- and…

  9. Association of Industry Funding with the Outcome and Quality of Randomized Controlled Trials of Drug Therapy for Rheumatoid Arthritis

    PubMed Central

    Khan, Nasim A.; Lombeida, Juan I.; Singh, Manisha; Spencer, Horace J.; Torralba, Karina D.

    2013-01-01

    Objective To assess the association of industry funding with the characteristics, outcome, and reported quality of randomized controlled trials (RCTs) of drug therapy for rheumatoid arthritis (RA). Methods MEDLINE and Cochrane Central Register of Controlled Trials databases were searched to identify original RA drug therapy RCTs published in 2002–3 & 2006–7. Two reviewers independently assessed each RCT for the funding source, characteristics, outcome [positive (statistically significant result favoring experimental drug for the primary outcome) or not positive], and reporting of methodological measures whose inadequate performance may bias treatment effect assessment. RCTs registered at ClinicalTrials.gov and completed in the study years were assessed for publication bias. Results 103 eligible RCTs were identified with following funding sources: 58 (56.3%) industry; 19 (18.4%) non-profit; 6 (5.8%) mixed; and 20 (19.4%) unspecified. Industry funded RCTs had significantly more study centers and subjects; while non-profit funded RCTs had longer duration, and were more likely to study different treatment strategies. Outcome could be assessed for 86 (83.5%) RCTs. Funding source was not associated with higher likelihood of positive outcomes favoring the sponsored experimental drug [industry (75.5%), non-profit (68.8%), mixed (40%), and unspecified (81.2%); p = 0.37]. Industry funded RCTs had trend towards higher likelihood of non-publication (38.6% versus 16.7%, p = 0.093). Industry-funded RCTs reported more frequent performance of double-blinding, adequate participant flow description, and intention-to-treat analysis. Conclusion Industry funding was not associated with higher likelihood of positive outcomes of published drug therapy RCTs for RA, and reported better on some key RCT quality measures. PMID:22275179

  10. 78 FR 75570 - Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-12

    ... Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing... or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily... Medicated Feed or Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors...

  11. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing... Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning... and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water...

  12. 78 FR 78366 - Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ... compendial drug products that contain a salt. Under the new policy, drug names and strengths for new compendial drug products will be based on the active moiety. The name and strength of the active ingredient... monograph title, and the strength will be expressed in terms of the active moiety. The policy allows...

  13. 75 FR 32953 - Guidance for Industry and Food and Drug Administration Staff; Use of “Light,” “Mild,” “Low,” or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Use...

  14. 76 FR 36307 - Guidance for Industry on Topical Acne Drug Products for Over-the-Counter Human Use-Revision of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 333 Guidance for Industry on Topical Acne Drug... availability of a guidance for small business entities entitled ``Topical Acne Drug Products for Over-the... ingredient in over-the-counter (OTC) topical acne drug products and provides new labeling...

  15. Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

    PubMed

    Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G

    2015-06-01

    Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.

  16. 77 FR 20025 - Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., 10903 New Hampshire Ave., Bldg. 51, Rm. 4288, Silver Spring, MD 20993-0002, 301- 796-0584; Paul Loebach, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg....

  17. 77 FR 72869 - Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-06

    ... for Drug Evaluation and Research's (CDER's) current thinking on the potential human health risks...-Regulated Products.'' This guidance provides the pharmaceutical industry with CDER's current thinking on the... have raised concerns, particularly in vulnerable populations such as pregnant women and...

  18. 78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ... efficiency of the review process. This draft guidance is not final nor is it in effect at this time. DATES... review process between FDA and industry for specific medical device premarket submissions. Further... recommendations for MDUFA III, Title II of the Food and Drug Administration Safety and Innovation Act, Public...

  19. Is there an industrial future for phytopharmaceutical drugs? An outline of UNIDO programmes in the sector.

    PubMed

    Wijesekera, R O

    1991-04-01

    Although a substantial proportion of the health-care expenditure of developing countries is spent on the acquisition of drugs, this is only sufficient to serve about a quarter of their population. Therefore it is inconceivable that WHO's goal of HEALTH FOR ALL by the year 2000 could even be approached without consideration being given to the role in health care systems of herbal medicines. In this endeavour, traditional herbal medicines must perforce be granted the benefits of modern science and technology to serve future global needs. Here we are addressing both a contigency situation as well as a long term one. In developing nations there is a dire need for an improved supply of therapeutic agents for a variety of diseases that are characteristic of deprivation and poverty. In addition herbal medicines promise to provide both concepts of therapy, as well as therapeutic agents in areas where modern medicine has few answers. UNIDO's programmes for technical assistance to developing nations aim at the fullest utilisation of traditional herbal-based pharmacopoeias in addressing both these situations. They have employed a multi-disciplinary approach to the industrial production of herbal medicines. The projects endeavour to utilise the natural flora, judiciously, for selection, domestication and crop-wise cultivation of medicinal plant species for industrial processing. National R & D efforts have been strengthened to include the development of expertise in several areas such as instrumental analyses, biological assessment of raw materials as well as products. Process technology development has received special attention. A versatile poly-functional pilot plant has been developed to enable the production of herbal preparations as well as extracts and phytochemicals.(ABSTRACT TRUNCATED AT 250 WORDS)

  20. 77 FR 61417 - Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-09

    ...: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Acute Bacterial Sinusitis: Developing Drugs for Treatment.'' This guidance addresses FDA's... an indication for the treatment of acute bacterial sinusitis (ABS). This guidance finalizes...

  1. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice..., and other entities about how the FDA intends to apply its regulatory authorities to select...

  2. Evaluation of a New Molecular Entity as a Victim of Metabolic Drug-Drug Interactions-an Industry Perspective.

    PubMed

    Bohnert, Tonika; Patel, Aarti; Templeton, Ian; Chen, Yuan; Lu, Chuang; Lai, George; Leung, Louis; Tse, Susanna; Einolf, Heidi J; Wang, Ying-Hong; Sinz, Michael; Stearns, Ralph; Walsky, Robert; Geng, Wanping; Sudsakorn, Sirimas; Moore, David; He, Ling; Wahlstrom, Jan; Keirns, Jim; Narayanan, Rangaraj; Lang, Dieter; Yang, Xiaoqing

    2016-08-01

    Under the guidance of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), scientists from 20 pharmaceutical companies formed a Victim Drug-Drug Interactions Working Group. This working group has conducted a review of the literature and the practices of each company on the approaches to clearance pathway identification (fCL), estimation of fractional contribution of metabolizing enzyme toward metabolism (fm), along with modeling and simulation-aided strategy in predicting the victim drug-drug interaction (DDI) liability due to modulation of drug metabolizing enzymes. Presented in this perspective are the recommendations from this working group on: 1) strategic and experimental approaches to identify fCL and fm, 2) whether those assessments may be quantitative for certain enzymes (e.g., cytochrome P450, P450, and limited uridine diphosphoglucuronosyltransferase, UGT enzymes) or qualitative (for most of other drug metabolism enzymes), and the impact due to the lack of quantitative information on the latter. Multiple decision trees are presented with stepwise approaches to identify specific enzymes that are involved in the metabolism of a given drug and to aid the prediction and risk assessment of drug as a victim in DDI. Modeling and simulation approaches are also discussed to better predict DDI risk in humans. Variability and parameter sensitivity analysis were emphasized when applying modeling and simulation to capture the differences within the population used and to characterize the parameters that have the most influence on the prediction outcome.

  3. Industry

    SciTech Connect

    Bernstein, Lenny; Roy, Joyashree; Delhotal, K. Casey; Harnisch, Jochen; Matsuhashi, Ryuji; Price, Lynn; Tanaka, Kanako; Worrell, Ernst; Yamba, Francis; Fengqi, Zhou; de la Rue du Can, Stephane; Gielen, Dolf; Joosen, Suzanne; Konar, Manaswita; Matysek, Anna; Miner, Reid; Okazaki, Teruo; Sanders, Johan; Sheinbaum Parado, Claudia

    2007-12-01

    This chapter addresses past, ongoing, and short (to 2010) and medium-term (to 2030) future actions that can be taken to mitigate GHG emissions from the manufacturing and process industries. Globally, and in most countries, CO{sub 2} accounts for more than 90% of CO{sub 2}-eq GHG emissions from the industrial sector (Price et al., 2006; US EPA, 2006b). These CO{sub 2} emissions arise from three sources: (1) the use of fossil fuels for energy, either directly by industry for heat and power generation or indirectly in the generation of purchased electricity and steam; (2) non-energy uses of fossil fuels in chemical processing and metal smelting; and (3) non-fossil fuel sources, for example cement and lime manufacture. Industrial processes also emit other GHGs, e.g.: (1) Nitrous oxide (N{sub 2}O) is emitted as a byproduct of adipic acid, nitric acid and caprolactam production; (2) HFC-23 is emitted as a byproduct of HCFC-22 production, a refrigerant, and also used in fluoroplastics manufacture; (3) Perfluorocarbons (PFCs) are emitted as byproducts of aluminium smelting and in semiconductor manufacture; (4) Sulphur hexafluoride (SF{sub 6}) is emitted in the manufacture, use and, decommissioning of gas insulated electrical switchgear, during the production of flat screen panels and semiconductors, from magnesium die casting and other industrial applications; (5) Methane (CH{sub 4}) is emitted as a byproduct of some chemical processes; and (6) CH{sub 4} and N{sub 2}O can be emitted by food industry waste streams. Many GHG emission mitigation options have been developed for the industrial sector. They fall into three categories: operating procedures, sector-wide technologies and process-specific technologies. A sampling of these options is discussed in Sections 7.2-7.4. The short- and medium-term potential for and cost of all classes of options are discussed in Section 7.5, barriers to the application of these options are addressed in Section 7.6 and the implication of

  4. [Approval of drugs by national and European agencies--sequelae for the pharmaceutical industry].

    PubMed

    Zierenberg, O

    1997-11-01

    The research-based pharmaceutical industry supports the European harmonization process for the granting of pharmaceutical registrations. In order to improve consumer protection and the therapeutic options available to physicians in comparison to nationally registered products, the harmonization must be carried out on schedule and transparently a high scientific standard. It must not lead to the adoption of all national restrictions regarding data sheets and patient leaflets. Pharmaceutical products with the same ingredients can be registered either through the national or through the European procedure. This situation can only be remedied by the harmonization of core SPCs. This process must be agreed in consultation between pharmaceutical companies and regulatory authorities. With regard to measures to avert drug risks, professional associations and the pharmaceutical companies affected should be heard by the national authorities and their arguments given due consideration. In addition, national authorities and the CPMP must coordinate their decisions before they are published. In particular, the basis of these decisions should be made clear and therapeutic alternatives should be known.

  5. Animals on drugs: understanding the role of pharmaceutical companies in the animal-industrial complex.

    PubMed

    Twine, Richard

    2013-12-01

    In this paper I revisit previous critiques that I have made of much, though by no means all, bioethical discourse. These pertain to faithfulness to dualistic ontology, a taken-for-granted normative anthropocentrism, and the exclusion of a consideration of how political economy shapes the conditions for bioethical discourse (Twine Medicine, Health Care and Philosophy 8(3):285-295, 2005; International Journal of Sociology of Agriculture and Food 16(3):1-18, 2007, 2010). Part of my argument around bioethical dualist ontology is to critique the assumption of a division between the "medical" (human) and "agricultural" (nonhuman) and to show various ways in which they are interrelated. I deepen this analysis with a focus on transnational pharmaceutical companies, with specific attention to their role in enhancing agricultural production through animal drug administration. I employ the topical case of antibiotics in order to speak to current debates in not only the interdisciplinary field of bioethics but also that of animal studies. More generally, the animal-industrial complex (Twine Journal for Critical Animal Studies 10(1):12-39, 2012) is underlined as a highly relevant bioethical object that deserves more conceptual and empirical attention.

  6. [Drug advertising as communication between the pharmaceutical industry and the physician: advertisements for psychotropic drugs in the Dutch medical journal, Nederlands Tijdschrift voor Geneeskunde, 1900-1940].

    PubMed

    van der Hoogte, Arjo Roersch; Pieters, Toine

    2010-01-01

    In this article we explore the historical development of drug advertisements for psychotropic drugs in the leading Dutch medical journal from 1900 to 1940. The advertisements for hypnotics and sedatives, in The Nederlands Tijdschrift voor Geneeskunde (Dutch medical journal) reflected the changes in the vocabulary and image promoted by the pharmaceutical companies. In the first two decades, the advertisements were sober and to the point, and included the trademark, company name, molecular formula and therapeutic properties of the medication. The emphasis was on creating a scientific image of reliable symptom control for the therapeutic drug. In doing so, the ethical drug companies tried (successfully) to distinguish themselves from the producers of patent medicines. Once scientific credibility was established, the form and content of the advertisements changed significantly. In the late 1920s and 1930s drug companies embraced modern advertising techniques, developing a figurative language to address the changing beliefs and practices of Dutch physicians. Instead of promoting therapeutic drugs as safe and scientific, the emphasis was on their effectiveness in comparison to similar drugs. In the process, scientific information was reduced to an indispensable standardized minimum, whereby therapeutic drugs were advertised according to the latest pharmacological taxonomy rather than molecular formulas. The image-making of 'ethical marketing' began during the interwar years when marketers applied modern advertising techniques and infotainment strategies. The scanty black and white informational bulletins transitioned into colourful advertisements. The pharmaceutical companies employed the same medical language as used by physicians, so that one word or image in an advertisement would suffice for the physician to recognize a drug and its therapeutic properties. These developments show the changing relationship between the modern ethical pharmaceutical industry and Dutch

  7. Reshaping the carcinogenic risk assessment of medicines: international harmonisation for drug safety, industry/regulator efficiency or both?

    PubMed

    Abraham, John; Reed, Tim

    2003-07-01

    The most significant institutional entity involved in the harmonisation of drug testing standards worldwide is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which comprises the three pharmaceutical industry associations and regulatory agencies of the EU, US and Japan. It is often claimed that such harmonisation will both accelerate the development and approval of new drugs and preserve safety standards, if not strengthen safety regimes. Drawing on extensive documentary research and interviews, this paper systematically examines whether the efforts by the ICH to improve industrial and regulatory efficiency by harmonising drug testing requirements is likely to raise, maintain or compromise safety standards in carcinogenic risk assessment of pharmaceuticals. The evidence suggests that, in the field of carcinogenicity testing, the ICH management of international harmonisation of medicines regulation is not achieving simultaneous improvements in safety standards and acceleration of drug development. Rather, the latter is being achieved at the expense of the former. Indeed, the ICH may be converting permissive regulatory practices of the past into new scientific standards for the future. These findings are significant as many expert scientific advisers to drug regulatory agencies seem to have accepted uncritically the conclusions reached by the ICH, which may affect a potential patient population of half a billion and tens of thousands of clinical trials.

  8. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

    ... Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and... Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act.'' This draft guidance provides updated... Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act.'' The...

  9. How the pill became a lifestyle drug: the pharmaceutical industry and birth control in the United States since 1960.

    PubMed

    Watkins, Elizabeth Siegel

    2012-08-01

    Marketing decisions, rather than scientific innovations, have guided the development and positioning of contraceptive products in recent years. I review the stalled progress in contraceptive development in the decades following the advent of the Pill in 1960 and then examine the fine-tuning of the market for oral contraceptives in the 1990s and 2000s. Although birth control has been pitched in the United States as an individual solution, rather than a public health strategy, the purpose of oral contraceptives was understood by manufacturers, physicians, and consumers to be the prevention of pregnancy, a basic health care need for women. Since 1990, the content of that message has changed, reflecting a shift in the drug industry's view of the contraception business. Two factors contributed to bring about this change: first, the industry's move away from research and development in birth control and second, the growth of the class of medications known as lifestyle drugs.

  10. How the Pill Became a Lifestyle Drug: The Pharmaceutical Industry and Birth Control in the United States Since 1960

    PubMed Central

    Watkins, Elizabeth Siegel

    2012-01-01

    Marketing decisions, rather than scientific innovations, have guided the development and positioning of contraceptive products in recent years. I review the stalled progress in contraceptive development in the decades following the advent of the Pill in 1960 and then examine the fine-tuning of the market for oral contraceptives in the 1990s and 2000s. Although birth control has been pitched in the United States as an individual solution, rather than a public health strategy, the purpose of oral contraceptives was understood by manufacturers, physicians, and consumers to be the prevention of pregnancy, a basic health care need for women. Since 1990, the content of that message has changed, reflecting a shift in the drug industry's view of the contraception business. Two factors contributed to bring about this change: first, the industry's move away from research and development in birth control and second, the growth of the class of medications known as lifestyle drugs. PMID:22698049

  11. Improving the translation in Europe of nanomedicines (a.k.a. drug delivery) from academia to industry.

    PubMed

    Eaton, Michael A W

    2012-12-28

    Over the last decade the involvement of European academic scientists in the translation of Nanomedicines and Drug Delivery into useful therapeutics has been modest. Funders have become increasingly concerned and some attempts have been made in Europe to improve impact. While the consequences are minimal at present for stakeholders, the eventual impact at national and political levels could be serious and is likely to lead to reverse innovation - the import of healthcare products from developing economies - if not addressed. Some knowledge of industrial drug development is critical for innovation in this regulated sector - this information being not easily obtained outside Pharma. While peer review has failings, more important is project inception, since once started research takes on a life of its own. This paper aims to encourage healthcare researchers to take a more translational approach to selecting (applied) drug delivery projects.

  12. Differences in the drug-metabolizing enzyme activities among fish and bivalves living in waters near industrial and non-industrial areas

    SciTech Connect

    Oshima, Y.; Kobayashi, K.; Hidaka, C.; Izu, S.; Imada, N. )

    1994-07-01

    Fish and shellfishes, living in coastal areas receiving agricultural, industrial and domestic wastewaters, have been exposed to various chemicals. Identifing the various harmful chemicals in the environments and accumulated in aquatic organisms is difficult. Even if concentrations of pollutants are low so that no mortality of fish and shellfishes occurs, the pollutants may affect the biochemistry and physiology of aquatic organisms. Activities of some drug-metabolizing enzymes, especially the cytochrome P-450 dependent monooxygenase (MO) in fish livers, increase when fish are exposed to environmental pollutants such as polycyclic aromatic hydrocarbons, halogenated organic chemicals. However, most studies have been done on the field evaluation only by MO induction in fish as a monitor for marine pollution with crude-oil and halogenated organic compounds, without regard for other chemicals. In a previous paper, the activity of benzo(a)pyrene hydroxylase (AHH) was induced by 22 times at 2-wk, although the cytochrome P-450 content increased only twice. Activity of phenol-sulfate transferase in the mid-gut gland of short-necked clam was induced by exposure to some phenolic compounds, especially pentachlorophenol (PCP), resulting in the increase of the enzyme activity by approximately 7 times the control after 5 wk exposure. Induced activity was maintained at least for 3 wk, even after the clam had been transferred to running clean sea water, although PCP accumulated in its body is rapidly excreted. Although the activity of this enzyme in the clam is easily induced by exposure to phenols, the induction of this enzyme activity in fish is very low as compared with that of clam. This paper examines the activities of drug-metabolizing enzymes of fish and bivalves living in waters near industrial and non-industrial areas to elucidate the applicability of the sulfate transferase activity in bivalves as a monitor for marine pollution, as well as the MO activity in fish.

  13. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ... clinical effectiveness studies, and describes criteria that the Center for Veterinary Medicine (CVM) thinks... represent the Agency's current thinking on evaluating the effectiveness of anticoccidial drugs in...

  14. Peering into the Pharmaceutical “Pipeline”: Investigational Drugs, Clinical Trials, and Industry Priorities

    PubMed Central

    Cottingham, Marci D.; Kalbaugh, Corey A.

    2014-01-01

    In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry’s investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding – and often problematic – role of pharmaceuticals in society. To access the pharmaceutical industry’s pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2,477 different drugs in 4,182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline were being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered. PMID:25159693

  15. 78 FR 42965 - Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-18

    ... Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridium... Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard... new drug (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat...

  16. 76 FR 60504 - Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ... (TEA) to determine whether a condition is eligible for inclusion in the OTC drug monograph system and... designed to clarify the TEA process and what happens after a TEA is submitted. This guidance finalizes the... regulation in Sec. 330.14, an applicant must first submit a TEA to show that the drug product is eligible...

  17. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-25

    ... qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple drug... Evaluation and Research (CDER) and DDT sponsors to support work towards qualification of an identified DDT and creates a mechanism for formal review of data by CDER to qualify the DDT and ensure that...

  18. 78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-07

    ...: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological... ``Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological... for sponsors to consider in developing information to support a marketing application for a pen,...

  19. Urinalysis and hair analysis for illicit drugs of driver applicants and drivers in the trucking industry.

    PubMed

    Mieczkowski, Tom

    2010-07-01

    The purpose of this article is to compare the differential rate of detection of illicit drugs when using two distinct sample types, hair and urine specimens. The specimens were collected from persons who applied for employment as a truck driver, or were collected from randomly selected currently employed truck drivers. The data is examined for job applicants and employees to determine if any differences in outcomes are associated with employment status or specimen type. The data is also assessed for specific patterns associated with particular drugs and their assay outcomes. Overall, it was determined that drug positive cases are relatively rare. Job applicants are more likely to test positive for an illicit drug than a currently employed driver. Applicants are more frequently positive for a drug by a factor of 3 for both urinalysis and hair analysis when compared to currently employed drivers. Approximately 2% of applicants were urine positive and 9% hair positive for an illegal drug. Considering employed truck drivers 0.6% were drug positive by urinalysis and 3% when using hair analysis. It is concluded that hair assays detect more drug use than urinalysis. It is also concluded that when urine and hair assay outcomes are non-concordant the typical case is a positive hair analysis with a negative urinalysis.

  20. English for the Engineer.

    ERIC Educational Resources Information Center

    Daugherty, Wilson

    1964-01-01

    A brief description of the English program for students of engineering, architecture, and industrial management at Lawrence Institute of Technology includes fairly detailed information on the unique features of the 3-term freshman English course. Less extensive reference to the details of the sophomore, junior, and senior courses precedes a short…

  1. 78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... guidance document provides advice to potential sponsors, such as cord blood banks, registries, transplant... New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood..., Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and...

  2. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Device Reporting for Manufacturers; Draft Guidance....115). The draft guidance, when finalized, will represent the Agency's current thinking on...

  3. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration... of the draft guidance entitled ``Medical Device Classification Product Codes.'' The purpose of the... classification product codes for medical devices regulated by the Center for Devices and Radiological...

  4. 77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ...--Premarket Notification (510(k)) Submissions; and Clinical Performance Assessment: Considerations for... Approval and Premarket Notification (510(k)) Submissions; Availability AGENCY: Food and Drug Administration... Applied to Radiology Images and Radiology Device Data--Premarket Notification (510(k)) Submissions''...

  5. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

    ... as on scientific information that has become available to the Agency. We believe the revisions will... the Agency's current thinking on BE studies with pharmacokinetic endpoints for drug products...

  6. Exploiting new approaches for natural product drug discovery in the biotechnology industry.

    PubMed

    Gullo, Vincent P; Hughes, Dallas E

    2005-01-01

    In recent years, large pharmaceutical companies have significantly reduced or eliminated the search for new therapeutic agents from natural sources. In spite of the many successes from natural product drug discovery, these companies have chosen to focus on compound libraries as the source of new lead compounds. Smaller biotechnology companies are continuing the search for novel natural products by developing and employing new and innovative approaches. This paper will describe some of these recent approaches to natural product drug discovery.:

  7. Rapid diagnostics of tuberculosis and drug resistance in the industrialized world: clinical and public health benefits and barriers to implementation

    PubMed Central

    2013-01-01

    In this article, we give an overview of new technologies for the diagnosis of tuberculosis (TB) and drug resistance, consider their advantages over existing methodologies, broad issues of cost, cost-effectiveness and programmatic implementation, and their clinical as well as public health impact, focusing on the industrialized world. Molecular nucleic-acid amplification diagnostic systems have high specificity for TB diagnosis (and rifampicin resistance) but sensitivity for TB detection is more variable. Nevertheless, it is possible to diagnose TB and rifampicin resistance within a day and commercial automated systems make this possible with minimal training. Although studies are limited, these systems appear to be cost-effective. Most of these tools are of value clinically and for public health use. For example, whole genome sequencing of Mycobacterium tuberculosis offers a powerful new approach to the identification of drug resistance and to map transmission at a community and population level. PMID:23987891

  8. Direct-to-consumer advertising of prescription drugs: European Commission persists in putting industry's interests first.

    PubMed

    2013-01-01

    In late September 2010, Members of the European Parliament (MEPs) issued their verdict on European Commission proposals aimed at lifting the ban on pharmaceutical companies communicating directly with the general public about prescription drugs. The MEPs were able to limit the scope of some of the more harmful aspects of these proposals, in particular by proposing that drug regulatory agencies should pre-screen the "information" produced by drug companies before it is made available to the public. In December 2010, faced with ongoing opposition from European Member States, the Commission appeared to back down, announcing that it was drawing up "amended proposals". They were publicly released in February 2012 but still leave the door open to direct-to-consumer advertising of prescription drugs, particularly "reminder advertising". As of 4 July 2012, the amended proposals had not yet been examined by Member States, thus obstructing the legislative process. Public health and management of the costs of social services for Member States are at stake. The Medicines in Europe Forum (MiEF) and the International Society of Drug Bulletins (ISDB) urge Member States to continue to refuse to examine the Commission's proposals, and have drawn up concrete counterproposals that would enable the general public to obtain relevant health information.

  9. Overview of the animal health drug development and registration process: an industry perspective.

    PubMed

    Hunter, Robert P; Shryock, Thomas R; Cox, Brian R; Butler, Roger M; Hammelman, Jason E

    2011-05-01

    Products for animal health commercialization follow a structured progression from initial concept through to regulatory approval. Typically, products are developed for use in either food animals or companion animals. These can be for the intention of disease intervention, productivity enhancement or improvement in a quality of life capacity. The animal health industry is a regulated industry, meaning that a government agency is responsible for oversight of products, both pre- and post-approval. There are three primary US government agencies that ensure quality, safety and effectiveness for the approval of new products and post-marketing compliance.

  10. 76 FR 36133 - Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-21

    ... if: ``through either chemical reaction or intermolecular forces or both, the product mediates a... Issues; and Interpretation of the Term ``Chemical Action'' in the Definition of Device Under Section 201...'' and ``Draft Guidance for Industry and FDA Staff: Interpretation of the Term 'Chemical Action' in...

  11. Where Are the Nanodrugs? An Industry Perspective on Development of Drug Products Containing Nanomaterials.

    PubMed

    Havel, Henry A

    2016-11-01

    While nanotechnology advancements have been applied to pharmaceutical products, the number of approved nanodrugs by global health authorities has not kept pace with research and development investments in the field. This article reviews the history of nanodrug development and provides an industrial context for realistic expectations in the future.

  12. A case in south-eastern France: a review of drug facilitated sexual assault in European and English-speaking countries.

    PubMed

    Dorandeu, Anne H; Pagès, Cheryl A; Sordino, Marie-Christine; Pépin, Gilbert; Baccino, Eric; Kintz, Pascal

    2006-07-01

    Drug facilitated sexual assaults (DFSA) have been increasingly reported in the medical literature since the 1980s but their legal recognition is more recent, at least in Europe. From a case treated in south-eastern France, whose judicial consequences were known, it seemed of interest to carry out an international study of jurisprudence concerning this type of rape. While from the medical viewpoint the drugs used are well-known and their presence can be clinically verified, the legal consequences of their use in subsequent criminal prosecution is less clear-cut. Some European countries have no jurisprudence in this area, while others consider the use of drugs as an aggravating circumstance. In France, it was only in 2003 that the first case of DFSA was truly punished by the judicial system, with considerable media attention. By contrast, in English-speaking countries, particularly the United States, the use of drugs to facilitate sexual assault has frequently been recognized in legislation and in criminal prosecutions. Prevention is fundamental and is recognised as demonstrated by campaigns in various countries.

  13. 78 FR 27116 - Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ..., to set forth criteria for charging for an investigational drug for the three types of expanded access... types of costs that can be recovered, FDA is providing a draft guidance in a question and answer format...ComplianceRegulatoryInformation/Guidances/default.htm ,...

  14. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ... HUMAN SERVICES Food and Drug Administration (formerly 1999D-4396) Guidance for Clinical Investigators... recommendations made by the Office of the Inspector General (OIG), Department of Health and Human Services, in... represents FDA's current thinking on this topic. It does not create or confer any rights for or on any...

  15. 75 FR 73109 - Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... this guidance is to provide information on FDA's current thinking regarding appropriate use of noninferiority (NI) clinical trial designs to evaluate antibacterial drug products. The Agency's thinking in this... Agency's current thinking on this topic. It does not create or confer any rights for or on any person...

  16. 78 FR 57859 - Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-20

    ... determine the potential for a drug to disrupt the endocrine system. This draft guidance also discusses... compounds that have the potential to interfere with some aspect of the endocrine system of an organism or its progeny. Any component of the endocrine system can be a target of endocrine disruptors,...

  17. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... HUMAN SERVICES Food and Drug Administration Medical Device Classification Product Codes; Guidance for... guidance entitled ``Medical Device Classification Product Codes.'' This document describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices...

  18. 76 FR 14024 - Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... includes only the information that these drugs are indicated to reduce blood pressure; the labeling does... blood pressure reduction. However, blood pressure control is well established as beneficial in... encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes...

  19. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-11

    ... Container Is Not Made With Natural Rubber Latex; Availability AGENCY: Food and Drug Administration, HHS... to include in the labeling of a medical product to convey that natural rubber latex was not used as a... for inclusion in medical product labeling such as ``latex-free,'' ``does not contain natural...

  20. 78 FR 27115 - Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... on this draft guidance before it begins work on the final version of the guidance, submit either... access under a treatment protocol or treatment investigational new drug application (IND). These... CFR part 56 (21 CFR 312.305(c)(4)). 21 CFR part 56 requires, among other things, that an IRB...

  1. 76 FR 34999 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... Methicillin-Resistant Staphylococcus Aureus for Culture-Based Devices; Availability AGENCY: Food and Drug... Diagnostic Devices for the Detection of Methicillin-Resistant Staphylococcus Aureus for Culture- Based... monitoring blood culture systems. This draft guidance is not final nor is it in effect at this time....

  2. 76 FR 50484 - Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for... Considerations for Pivotal Clinical Investigations for Medical Devices.'' This document is intended to provide... to fulfill premarket clinical data requirements. This draft guidance is not final nor is it in...

  3. Anaerobic treatment of wastewater with high suspended solids from a bulk drug industry using fixed film reactor (AFFR).

    PubMed

    Gangagni Rao, A; Venkata Naidu, G; Krishna Prasad, K; Chandrasekhar Rao, N; Venkata Mohan, S; Jetty, Annapurna; Sarma, P N

    2005-01-01

    Studies were carried out on the treatment of wastewater from a bulk drug industry using an anaerobic fixed film reactor (AFFR) designed and fabricated in the laboratory. The chemical oxygen demand (COD) and total dissolved solids (TDS) of the wastewater were found to be very high with low biochemical oxygen demand (BOD) to COD ratio and high total suspended solid (TSS) concentration. Acclimatization of seed consortia and startup of the reactor was carried out by directly using the wastewater, which resulted in reducing the period of startup to 30 days. The reactor was studied at different organic loading rates (OLR) and it was found that the optimum OLR was 10 kg COD/m(3)/day. The wastewater under investigation, which had a considerable quantity of SS, was treated anaerobically without any pretreatment. COD and BOD of the reactor outlet wastewater were monitored and at steady state and optimum OLR 60-70% of COD and 80-90% of BOD were removed. The reactor was subjected to organic shock loads at two different OLR and the reaction could withstand the shocks and performance could be restored to normalcy at that OLR. The results obtained indicated that AFFR could be used efficiently for the treatment of wastewater from a bulk drug industry having high COD, TDS and TSS.

  4. Anaerobic treatment of wastewater with high suspended solids from a bulk drug industry using fixed film reactor (AFFR).

    PubMed

    Rao, A Gangagni; Naidu, G Venkata; Prasad, K Krishna; Rao, N Chandrasekhar; Mohan, S Venkata; Jetty, Annapurna; Sarma, P N

    2004-07-01

    Studies are carried out on the treatment of wastewater from a bulk drug industry using an anaerobic fixed film reactor (AFFR) designed and fabricated in the laboratory. The chemical oxygen demand (COD) and total dissolved solids (TDS) of the wastewater are found to be very high with low Biochemical oxygen demand (BOD) to COD ratio and high total suspended solid (TSS) concentration. Acclimatization of seed consortia and start up of the reactor is carried out by directly using the wastewater, which resulted in reducing the period of startup to 30 days. The reactor is studied at different organic loading rates (OLR) and it is found that the optimum OLR is 10 kg COD/m3/day. The wastewater under investigation, which is having considerable quantity of SS, is treated anaerobically without any pretreatment. The COD and BOD of the reactor outlet wastewater are monitored and reduction at steady state and optimum OLR is observed to be 60-70% of COD and 80-90% of BOD. The reactor is subjected to organic shock loads at two different OLR and it is observed that the reactor could withstand shocks and performance could be restored to normalcy at that OLR. The results obtained indicated that AFFR could be used efficiently for the treatment of wastewater from a bulk drug industry having high COD, TDS and TSS.

  5. Binding Free Energy Calculations for Lead Optimization: Assessment of Their Accuracy in an Industrial Drug Design Context.

    PubMed

    Homeyer, Nadine; Stoll, Friederike; Hillisch, Alexander; Gohlke, Holger

    2014-08-12

    Correctly ranking compounds according to their computed relative binding affinities will be of great value for decision making in the lead optimization phase of industrial drug discovery. However, the performance of existing computationally demanding binding free energy calculation methods in this context is largely unknown. We analyzed the performance of the molecular mechanics continuum solvent, the linear interaction energy (LIE), and the thermodynamic integration (TI) approach for three sets of compounds from industrial lead optimization projects. The data sets pose challenges typical for this early stage of drug discovery. None of the methods was sufficiently predictive when applied out of the box without considering these challenges. Detailed investigations of failures revealed critical points that are essential for good binding free energy predictions. When data set-specific features were considered accordingly, predictions valuable for lead optimization could be obtained for all approaches but LIE. Our findings lead to clear recommendations for when to use which of the above approaches. Our findings also stress the important role of expert knowledge in this process, not least for estimating the accuracy of prediction results by TI, using indicators such as the size and chemical structure of exchanged groups and the statistical error in the predictions. Such knowledge will be invaluable when it comes to the question which of the TI results can be trusted for decision making.

  6. Delays in new drug applications in Japan and industrial R&D strategies.

    PubMed

    Hirai, Y; Kinoshita, H; Kusama, M; Yasuda, K; Sugiyama, Y; Ono, S

    2010-02-01

    The gap between Japan and both the United States (US) and the European Union (EU) with regard to access to new drugs is becoming a major issue in Japan. We analyzed the time lags involved in new drug application (NDA) and biological license application submissions in Japan, the US, and the EU in order to identify the causes of delayed access. The time lag related to submission of applications ("submission lag") was longer for in-licensed products and for non-Japanese companies. Factors related to costs of clinical studies and potential volumes of sales were not associated with the submission lag. A bridging strategy (extrapolative use of foreign clinical data in the clinical data package based on International Conference on Harmonisation guideline E5) seemed to reduce submission lag, but the association between the two diminished when the cause-and-effect relationship was specifically investigated. These results suggest that multinational companies are likely to place more emphasis on the choice of development strategies that successfully lead to their goal rather than on direct costs and expected sales when deciding to introduce their pharmaceutical products in Japan. Our findings indicate that the clinical development guidances that helps pharmaceutical companies decide on investment and strategies are also the key to narrowing the gap in access to new drugs.

  7. English Business Communication Skills Training Needs of Non-Native English-Speaking Managers: A Case in Taiwan.

    ERIC Educational Resources Information Center

    Tsui, Chia-Jung

    1992-01-01

    Discusses results of a survey of managers in high-technology industry in Taiwan regarding their needs for English business communication skills in the workplace. Finds that English conversation and English telephoning are the most urgently needed training courses. (SR)

  8. Assessing the relative efficiency of water companies in the English and Welsh water industry: a metafrontier approach.

    PubMed

    Molinos-Senante, María; Maziotis, Alexandros; Sala-Garrido, Ramon

    2015-11-01

    The assessment of relative efficiency of water companies is essential for managers and authorities. This is evident in the UK water sector where there are companies with different services such as water and sewerage companies (WaSCs) and water-only companies (WoCs). Therefore, it is a critical limitation to estimate a common production frontier for both types of companies, as it might lead to biased efficiency estimates. In this paper, a robust and reliable methodology, the metafrontier model, is applied to compare the efficiency of water companies providing different services. The results illustrate the superior performance of WaSCs compared to WoCs. It also confirms the presence of economies of scope in the UK water industry. The methodology and results of this study are of great interest for both regulators and water utility managers to make informed decisions.

  9. Drug reformulations and repositioning in the pharmaceutical industry and their impact on market access: regulatory implications

    PubMed Central

    Murteira, Susana; Millier, Aurélie; Ghezaiel, Zied; Lamure, Michel

    2014-01-01

    Background Repurposing has become a mainstream strategy in drug development, but it faces multiple challenges, amongst them the increasing and ever changing regulatory framework. This is the second study of a series of three-part publication project with the ultimate goal of understanding the market access rationale and conditions attributed to drug repurposing in the United States and in Europe. The aim of the current study to evaluate the regulatory path associated with each type of repurposing strategy according to the previously proposed nomenclature in the first article of this series. Methods From the cases identified, a selection process retrieved a total of 141 case studies in all countries, harmonized for data availability and common approval in the United States and in Europe. Regulatory information for each original and repurposed drug product was extracted, and several related regulatory attributes were also extracted such as, designation change and filing before or after patent expiry, among others. Descriptive analyses were conducted to determine trends and to investigate potential associations between the different regulatory paths and attributes of interest, for reformulation and repositioning cases separately. Results Within the studied European countries, most of the applications for reformulated products were filed through national applications. In contrast, for repositioned products, the centralized procedure was the most frequent regulatory pathway. Most of the repurposing cases were approved before patent expiry, and those cases have followed more complex regulatory pathways in the United States and in Europe. For new molecular entities filed in the United States, a similar number of cases were developed by serendipity and by a hypothesis-driven approach. However, for the new indication's regulatory pathway in the United States, most of the cases were developed through a hypothesis-driven approach. Conclusion The regulations in the United

  10. The drugs industry and peasant self-defence in a Peruvian cocaine enclave.

    PubMed

    van Dun, Mirella

    2012-11-01

    This article gives a detailed account of the cocaine industry and the related violence in the Peruvian Upper Huallaga. It is argued that in this cocaine producing region violence increased during state-led forced eradication operations of the coca plants. Most of the violent incidents were closely related to the diminishing cocaine industry, but they were also related to the actions of the state security forces. Instead of receiving support from the state's security apparatus, the population mobilized its own forces to fight the violence. As will be argued, the causes of violence in this cocaine enclave are part of a dynamic interaction amongst many factors - an interaction that is influenced by the local context, a partial state vacuum, and the social utility and the economic advantages of violence. One needs to be aware that motivations of those who engage in the violent behaviour can change over time, as underlying power structures are influenced by changes in local conditions. The study covers an in-depth account of events taking place in the Upper Huallaga during the years 2003-2007. The research material was collected by several ethnographical fieldwork methods.

  11. [Incentives and disincentives for research and development of new drugs by the pharmaceutical industry].

    PubMed

    Curcio, Pasqualina Curcio

    2008-10-01

    The authors present a model with factors that influence research and development decisions by the pharmaceutical industry: risk of disease transmission and possibility of control; case-fatality and the presence of cure or treatments; income; number of persons who demand the medicine; and opportunity costs for the company. Companies tend to invest in markets with inelastic demand (highly contagious diseases with no possibility of controlling transmission and/or very lethal diseases without treatment) and/or where there is a large population or high per capita income. Companies tend not to invest in markets where marginal costs exceed marginal income, particularly when costs increase permanently as a consequence of rising opportunity costs generated by foregoing profit in other markets. In such cases, policies to subsidize R&D are not effective, and policies must be orientated towards strengthening basic and applied research by public institutions.

  12. Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: reassessment of nomenclature

    PubMed Central

    Murteira, Susana; Ghezaiel, Zied; Karray, Slim; Lamure, Michel

    2013-01-01

    Background Medicinal products that have been developed and approved for one disease may be the object of additional clinical development in other disease areas or of additional pharmaceutical development for new and different formulations. The newly developed products can be named as repositioned or reformulated products, respectively. Market access of repositioned or reformulated products in Europe and the United States is an interesting object of study as it may provide clarity about which parameters are assessed and considered to bring added value, other than the molecule itself. As such, we aim to evaluate if the added value of repositioned or reformulated medicinal products can be systematically described, quantified, and predicted. As a first step toward investigating the impact of market access on drug research and development trends for repositioned and reformulated products, it is necessary to have consistency in the designations for the case studies evaluated in this project. In an attempt to achieve that consistency, the current study aims to propose harmonized definitions for the repositioning and reformulation strategies and to propose a taxonomy for the medicinal products derived thereof. Methods A systematic literature review was conducted to collect information on existing cases of repositioning or reformulation. A search strategy was developed by defining the search objectives, targeted data sources, search keywords, and inclusion/exclusion criteria for the retrieved documents. Results A total of 505 publications were retrieved through a search of the main data sources. The screenings and the ad hoc search led to a total of 56 publications to be used for the case study data extraction. In total, 87 repositioning and/or reformulation cases were found described in the literature, 23 of which presented different definitions and/or classifications by different authors. Conclusion Given the disparity and inconsistency of terminologies and

  13. Biological treatment of steroidal drug industrial effluent and electricity generation in the microbial fuel cells.

    PubMed

    Liu, Ru; Gao, Chongyang; Zhao, Yang-Guo; Wang, Aijie; Lu, Shanshan; Wang, Min; Maqbool, Farhana; Huang, Qing

    2012-11-01

    The single chamber microbial fuel cells (MFCs) were used to treat steroidal drug production wastewater (SPW) and generate electricity simultaneously. The results indicated that the maximum COD removal efficiency reached 82%, total nitrogen and sulfate removal rate approached 62.47% and 26.46%, respectively. The maximum power density and the Coulombic efficiency reached to 22.3Wm(-3) and 30%, respectively. The scanning electron microscope showed that the dominant microbial populations were remarkably different in morphology on the surface of SPW and acetate-fed anodes. PCR-denaturing gradient gel electrophoresis profiles revealed that the microbial community structure fed with different concentrations of SPW presented a gradual succession and unique bacterial sequences were detected on the SPW and acetate-fed anodes. This research demonstrates that MFCs fed with SPW achieved a high efficiency of power density and simultaneous nutrient removal, and the dominant microorganisms on the anode were related to the types and the concentrations of substrates.

  14. Compliance with the new Food and Drug Administration regulations: an approach by industry.

    PubMed

    Ward, J W

    1981-09-01

    Good Laboratory Practice regulations became effective on June 20, 1979. The regulations provide guidance for the proper conduct and reporting of nonclinical laboratory studies on articles regulated by the United States Food and Drug Administration. A fundamental requirement of the regulations is the establishment of a quality assurance unit within each research facility to ensure the utilization and maintenance of good laboratory practices. A second significant feature is the requirement for an archival unit responsible for maintaining all raw data, documentation, protocols, specimens, and final reports. Experience with the regulations has been mixed. The quality of reports has been upgraded dramatically. Protocols contain more information than ever, data recording is more extensive and more carefully executed, and reports are prepared more carefully and edited more thoroughly. Conversely, there is no real evidence that quality of science has been improved, and costs have increased markedly.

  15. Drugs.

    ERIC Educational Resources Information Center

    Hurst, Hunter, Ed.; And Others

    1984-01-01

    This document contains the third volume of "Today's Delinquent," an annual publication of the National Center for Juvenile Justice. This volume deals with the issue of drugs and includes articles by leading authorities in delinquency and substance abuse who share their views on causes and cures for the drug problem among youth in this country.…

  16. Graphical display of histopathology data from toxicology studies for drug discovery and development: An industry perspective.

    PubMed

    Brown, Alan P; Drew, Philip; Knight, Brian; Marc, Philippe; Troth, Sean; Wuersch, Kuno; Zandee, Joyce

    2016-12-01

    Histopathology data comprise a critical component of pharmaceutical toxicology studies and are typically presented as finding incidence counts and severity scores per organ, and tabulated on multiple pages which can be challenging for review and aggregation of results. However, the SEND (Standard for Exchange of Nonclinical Data) standard provides a means for collecting and managing histopathology data in a uniform fashion which can allow informatics systems to archive, display and analyze data in novel ways. Various software applications have become available to convert histopathology data into graphical displays for analyses. A subgroup of the FDA-PhUSE Nonclinical Working Group conducted intra-industry surveys regarding the use of graphical displays of histopathology data. Visual cues, use-cases, the value of cross-domain and cross-study visualizations, and limitations were topics for discussion in the context of the surveys. The subgroup came to the following conclusions. Graphical displays appear advantageous as a communication tool to both pathologists and non-pathologists, and provide an efficient means for communicating pathology findings to project teams. Graphics can support hypothesis-generation which could include cross-domain interactive visualizations and/-or aggregating large datasets from multiple studies to observe and/or display patterns and trends. Incorporation of the SEND standard will provide a platform by which visualization tools will be able to aggregate, select and display information from complex and disparate datasets.

  17. Nonclinical reproductive toxicity testing requirements for drugs, pesticides, and industrial chemicals in India and China.

    PubMed

    Rao, K S; Dong, Jing

    2013-01-01

    India and China have booming chemical, agrochemical, and pharmaceutical industries. Both countries also represent expanding markets for foreign chemical and healthcare companies. All such products require reproductive toxicity testing before marketing. The ICH testing guidelines for medicinal products are not applicable in China and India. Nonetheless, reproductive toxicity studies designed and run to ICH principles are generally acceptable for submission. The Chinese guidelines take into consideration traditional Chinese medicines, which are usually mixtures. Likewise, the specific recommendations of India and China for the reproductive toxicity testing of chemicals and pesticides differ from those of the OECD and the USEPA. Again, studies performed in accordance with internationally recognized principles are usually acceptable for submission in both countries. The Chinese guideline for the reproductive toxicity testing of agrochemicals is currently under revision; the new version is expected to resemble more closely the requirements of the OECD and the USEPA. As a member of the OECD, India has conducted Good Laboratory Practice (GLP) inspection, accreditation, and monitoring activities since 2004. China has made several attempts to join the Council Decisions on Mutual Acceptance of Data in the Assessment of Chemicals since 2005. Currently 47 laboratories in China have been certified by the national GLP authorities. Several laboratories in China have also been recently been certified by OECD member countries as GLP compliant. In India, there are currently 23 GLP-Certified laboratories; about six of these are also AALAC accredited. The specific study designs specified in the guidelines of China and India for reproductive toxicity studies are described in detail in this chapter.

  18. 76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ...; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration...) of the Federal Food, Drug, and Cosmetic Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C...

  19. Industry practices and compliance with U.S. Food and Drug Administration guidelines among California sprout firms.

    PubMed

    Thomas, Jennifer L; Palumbo, Mary S; Farrar, Jeff A; Farver, Thomas B; Cliver, Dean O

    2003-07-01

    Since 1995, raw vegetable sprouts have been implicated as the vehicle of infection in 15 foodborne outbreaks involving Salmonella and 2 foodborne outbreaks involving Escherichia coli O157:H7. To reduce the numbers of sprout-related outbreaks, the U.S. Food and Drug Administration (FDA) published Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouting Seeds in 1999. Between October 2000 and April 2001, 61.5% (16 of 26) of the known commercial sprout firms in California were enrolled in a survey to evaluate the industry practices of California sprouting operations and to determine compliance with FDA guidelines. A standardized questionnaire was used to collect data on firm demographics and seed disinfection practices. Additionally, free chlorine levels in seed disinfection solutions were measured, and 48-h spent irrigation water samples were collected from each firm. The irrigation water was screened for Salmonella and E. coli O157:H7 with FDA-recommended test kits. Free chlorine levels in the treatment solutions ranged from 50 to 35,000 mg/liter (ppm), with a median of 14,000 mg/liter (ppm). Free chlorine levels were higher for firms producing alfalfa sprouts than for those producing only mung bean or soybean sprouts (P=0.03). Levels of free chlorine tended to be higher for firms using a calcium hypochlorite treatment solution than for firms using a sodium hypochlorite treatment solution (P=0.067). All 32 irrigation water samples screened for Salmonella tested negative. Of the irrigation water samples tested for E. coil O157:H7, 75% (24 of 32) tested negative, and 25% (8 of 32) tested presumptive positive. The eight presumptive positive samples were found to be negative after further testing. These results indicate that producers of alfalfa sprouts are generally achieving the FDA-recommended calcium hypochlorite level of 20,000 mg/liter (ppm), whereas mung bean sprout producers are not.

  20. Art English.

    ERIC Educational Resources Information Center

    Preece, Robert

    1994-01-01

    Art English is a combination of English-as-a-Second-Language (ESL)/English-as-a-Foreign-Language (EFL) and art content. As a new instructional area, it faces several challenges: as with all English for Special Purposes (ESP), exchange of information among programs; development of a suitable combination of art content and ESL, due to lack of…

  1. 78 FR 48172 - Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ...] [FR Doc No: 2013-19018] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket... and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...

  2. 76 FR 5387 - Guidance for Industry and Food and Drug Administration Staff; “`Harmful and Potentially Harmful...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-31

    ... Food, Drug, and Cosmetic Act''; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' This guidance provides written guidance to... Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' The...

  3. Perspectives on World English.

    ERIC Educational Resources Information Center

    Nelson, Cecil L.

    1988-01-01

    English is the most widely used language for commerce, industrial expansion, diplomacy, science, and other fields. As speakers of other languages adapt it to their purposes, educators must adjust their perceptions of how the language is used. This idea, and related ones, are discussed in this article. (JL)

  4. 77 FR 12311 - Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-29

    ... applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current thinking on appropriate size... submitting NDAs, ANDAs, and BLAs CDER's current thinking on appropriate size ranges for beads in drug... guidance represents the Agency's current thinking on the size of beads in drug products labeled...

  5. 75 FR 32952 - Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... the Federal Food, Drug, and Cosmetic Act''; Availability AGENCY: Food and Drug Administration, HHS... Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance... Cosmetic Act.'' This draft guidance, when finalized, will discuss the meaning of the term ``harmful...

  6. Coalition Priorité Cancer and the pharmaceutical industry in Quebec: conflicts of interest in the reimbursement of expensive cancer drugs?

    PubMed

    Hughes, David; Williams-Jones, Bryn

    2013-08-01

    In the context of scarce public resources, patient interest groups have increasingly turned to private organizations for financing, including the pharmaceutical industry. This practice puts advocacy groups in a situation of potential conflicts between the interests of patients and those of the drug companies. The interests of patients and industry can converge on issues related to the approval and reimbursement of medications. But even on this issue, interests do not always align perfectly. Using the Quebec example of Coalition Priorité Cancer (CPC) as a case study, we examine the ethical issues raised by such financial relationships in the context of drug reimbursement decision-making. We collected, compiled and analyzed publicly available information on the CPC's organization and activities; this approach allowed us to raise and discuss important questions regarding the possible influence exerted on patient groups by donors. We conclude with some recommendations.

  7. Transnational industrial power, the medical profession and the regulatory state: adverse drug reactions and the crisis over the safety of Halcion in the Netherlands and the UK.

    PubMed

    Abraham, John

    2002-11-01

    Taking the controversy over the safety of the hypnotic, Halcion, in the Netherlands and the UK, as a case study, this article examines the problems for public health associated with responses to warnings about drug hazards by regulatory agencies, governmental expert advisers, the pharmaceutical industry and the medical profession. It is argued that regulators and the medical profession rely too heavily on manufacturers to investigate warnings from doctors' spontaneous reporting of adverse effects of drug products on the market. It is demonstrated that a pharmaceutical firm's commitment to search effectively for evidence against the safety of its own product in order to confirm doctors' warnings can have severe limitations. Deficiencies in the socio-institutional responses to post-market 'early warning systems' about drug hazards imply that the regulatory policies of 'early licensing' and minimal pre-market checks for new drugs are misconceived and threaten public health. To improve public protection from drug injury, the regulators should abandon their conviction that compelling evidence of drug hazards are required to confirm doctors' warning signals prior to regulatory intervention. Instead, they should adopt a policy of measured regulatory intervention as an immediate response to warning signals, while investigators, independent of the manufacturers, assess the significance of the signal.

  8. Comparison of problematic behaviours of 10th and 11th year Southern English adolescents. Part 2: Current drink, drug and sexual activity of children with smoking parents.

    PubMed

    Cox, Malcolm; Pritchard, Colin

    2007-01-01

    To determine parental and school influences upon the behaviour and attitudes of adolescents of smoking versus non-smoking parents and of those "liking and disliking" school. Utilising a self-administered confidential standardised questionnaire, a representative sample of Southern English 10th and 11th year secondary school pupils was obtained. Current drink, drug and sexual behaviour were explored and data on adolescents whose parents smoked was extrapolated and compared against adolescents of non-smoking parents. Pupils reporting "liking school" were compared against those "not liking school" and all results statistically analysed. There were 17% smoking mothers [SM] and 23% smoking fathers [SF]. The focus is upon students of SF whose adolescents are significantly more often engaged in substance misuse (38-18%), drinking in pubs (31%-15%), binge drinking (32%-18%), and under-age sexual activity (27%-14%) plus smoking (51%-32%), truanting (43%-23%), vandalism (32%-22%) and stealing (19%-11%). SM students had higher incidence of sexual behaviour (33%-13%) and unprotected sex (21%-6%). Students of smoking parents were less well informed and had significantly more negative attitudes about social behaviour and responsibility. "Liking school" was associated to significantly lower rates of problematic behaviour, which predominately was not related to the social background of the pupils. The smoking father criteria carries a social class bias, nonetheless these parents need to be aware of the particular behaviour of their children and their increased risk. SF do not "cause" the behaviour rather it reflects something of the nature of the adolescent's relationship to parents, school and society.

  9. The Effects of Paper-Based Portfolios and Weblog-Based Electronic Portfolios on Limited English Proficiency Students in Writing for Service Industry Course

    ERIC Educational Resources Information Center

    Wanchid, Raveewan; Charoensuk, Valaikorn

    2015-01-01

    The purposes of this study were to investigate the effects of the use of paper-based and weblog-based electronic portfolios on the writing achievement of limited English proficiency students, to survey the students' attitudes towards the use of the portfolio assessment, and to compare the viewpoints of the students in the control and experimental…

  10. Career Education: Learning with a Purpose. Secondary Guide-Vol. 1. Art, English, Industrial Arts, Physical Education, Science, Field Trips and Guest Speakers.

    ERIC Educational Resources Information Center

    Atkinson, Marilyn; And Others

    The guide offers a compilation of teacher developed career education materials which may be integrated with secondary level curriculum and, in some cases, complete unit or course outlines are included. Suggested activities and ideas are presented for the following five subject areas and their related units: art, English (activity suggestions for…

  11. State-of-the-art and dissemination of computational tools for drug-design purposes: a survey among Italian academics and industrial institutions.

    PubMed

    Artese, Anna; Alcaro, Stefano; Moraca, Federica; Reina, Rocco; Ventura, Marzia; Costantino, Gabriele; Beccari, Andrea R; Ortuso, Francesco

    2013-05-01

    During the first edition of the Computationally Driven Drug Discovery meeting, held in November 2011 at Dompé Pharma (L'Aquila, Italy), a questionnaire regarding the diffusion and the use of computational tools for drug-design purposes in both academia and industry was distributed among all participants. This is a follow-up of a previously reported investigation carried out among a few companies in 2007. The new questionnaire implemented five sections dedicated to: research group identification and classification; 18 different computational techniques; software information; hardware data; and economical business considerations. In this article, together with a detailed history of the different computational methods, a statistical analysis of the survey results that enabled the identification of the prevalent computational techniques adopted in drug-design projects is reported and a profile of the computational medicinal chemist currently working in academia and pharmaceutical companies in Italy is highlighted.

  12. Teaching English.

    ERIC Educational Resources Information Center

    Nemanich, Donald, Ed.

    1975-01-01

    Articles in this volume of the "Illinois English Bulletin" include "Competencies in Teaching English" by Alan C. Purves, which sets forth a tentative model for planning competency-based instruction and certification based on concepts, teaching acts, skills, and strategies; "Passing the Buck Versus the Teaching of English" by Dennis Q. McInerny,…

  13. Earphone English.

    ERIC Educational Resources Information Center

    Goldsmith, Francisca

    2002-01-01

    Describes Earphone English, a student club sponsored through a partnership between Berkeley High School and the Berkeley Public Library that offers students whose primary language is not English to practice their spoken and aural English skills. Discusses the audiobooks used in the program and the importance of multicultural content and age…

  14. Nasal-to-CNS drug delivery: where are we now and where are we heading? An industrial perspective.

    PubMed

    Landis, Margaret S; Boyden, Tracey; Pegg, Simon

    2012-02-01

    Delivery of drug therapeutics across the blood-brain barrier is a challenging task for pharmaceutical scientists. Nasal-to-CNS drug delivery has shown promising results in preclinical efficacy models and investigatory human clinical trials. The further development of this technology with respect to the establishment of valid, predictable preclinical species models, translatable pharmacokinetic-pharmacodynamic relationships and definition of toxicology impact will help attract additional pharmaceutical investment in this drug-delivery approach. Further discoveries in nasal nanotechnology, targeted delivery devices and diagnostic olfactory imaging will serve to fuel the advancements in this area of drug delivery.

  15. 76 FR 59705 - Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or the..., 10903 New Hampshire Ave., Bldg. 51, rm. 6216, Silver Spring, MD 20993-0002, 301-796-3602; or Stephen... guidance represents the Agency's current thinking on user fee waivers and reductions for drug products....

  16. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... and Research. This draft guidance is not final nor is it in effect at this time. DATES: Although you... Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401..., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville...

  17. 76 FR 13629 - Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401... Food, Drug, and Cosmetic Act (the FD&C Act). This revised draft guidance describes the types of waivers...ComplianceRegulatoryInformation/Guidances/default.htm ,...

  18. Influence of kidney disease on drug disposition: An assessment of industry studies submitted to the FDA for new chemical entities 1999-2010.

    PubMed

    Matzke, Gary R; Dowling, Thomas C; Marks, Samantha A; Murphy, John E

    2016-04-01

    In 1998, the United States Food and Drug Administration (FDA) released the first guidance for industry regarding pharmacokinetic (PK) studies in renally impaired patients. This study aimed to determine if the FDA renal PK guidance influenced the frequency and rigor of renal studies conducted for new chemical entities (NCEs). FDA-approved package inserts (APIs) and clinical pharmacology review documents were analyzed for 194 NCEs approved from 1999 to 2010. Renal studies were conducted in 71.6% of NCEs approved from 1999 to 2010, a significant increase over the 56.3% conducted from 1996 to 1997 (P = .0242). Renal studies were more likely to be completed in highly renally excreted drugs (fe ≥ 30%) compared with drugs with low renal excretion, fe < 30% (89.6% vs 65.8%, P = .0015). PK studies to assess the impact of dialysis were conducted for 31.7% of NCEs that had a renal study: a greater proportion of high fe NCEs were studied (44.2% vs 26.0%, P = .0335). No significant change in frequency or rigor of PK studies was detected over time. The majority of NCEs (76.3%) with a renal study provided specific dosing recommendations in the API. The adoption of the 1998 FDA guidance has resulted in improved availability of PK and drug-dosing recommendations, particularly for high fe drugs.

  19. What Are Drugs?

    ERIC Educational Resources Information Center

    Minnesota Police and Peace Officers Association.

    This guide for parents presents, in Laotian and English, information about drugs, drug use and abuse, and treatment for drug use. Most of the information is presented in question and answer form to give parents the information they need to answer their children's questions and help prevent drug use. The following sections are included: (1)…

  20. The combination of glycerol metabolic engineering and drug resistance marker-aided genome shuffling to improve very-high-gravity fermentation performances of industrial Saccharomyces cerevisiae.

    PubMed

    Wang, Pin-Mei; Zheng, Dao-Qiong; Liu, Tian-Zhe; Tao, Xiang-Lin; Feng, Ming-Guang; Min, Hang; Jiang, Xin-Hang; Wu, Xue-Chang

    2012-03-01

    A challenge associated with the ethanol productivity under very-high-gravity (VHG) conditions, optimizing multi-traits (i.e. byproduct formation and stress tolerance) of industrial yeast strains, is overcome by a combination of metabolic engineering and genome shuffling. First, industrial strain Y12 was deleted with a glycerol exporter Fps1p and hetero-expressed with glyceraldehydes-3-phosphate dehydrogenase, resulting in the modified strain YFG12 with lower glycerol yield. Second, YFG12 was subjected to three rounds of drug resistance marker-aided genome shuffling to increase its ethanol tolerance, and the best shuffled strain TS5 was obtained. Compared with wild strain Y12, shuffled strain TS5 not only decreased glycerol formation by 14.8%, but also increased fermentation rate and ethanol yield by 3.7% and 7.6%, respectively. Moreover, the system of genetic modification and Cre/loxP in aid of three different drug-resistance markers presented in the study significantly improved breeding efficiency and will facilitate the application of breeding technologies in prototrophic industrial microorganisms.

  1. The innovative use of a large-scale industry biomedical consortium to research the genetic basis of drug induced serious adverse events.

    PubMed

    Holden, Arthur L

    2007-01-01

    The International Serious Adverse Event Consortium (SAEC) is a pharmaceutical industry and FDA led international (501 c3 non-profit) consortium, focused on identifying and validating DNA-variants useful in predicting the risk of drug induced, rare serious adverse events (SAEs). As such, it functions with the explicit purpose of enhancing the 'public good'. Its members are (i) organizations engaged principally in the business of discovering, developing and marketing pharmaceutical products, or (ii) a charitable, governmental, or other non-profit organization with an interest in researching the molecular basis of drug response.Drug-induced, rare SAEs present significant health issues for patients; and pose challenges for the safe use of approved drugs and the development of new drugs. Examples of drug-induced, rare SAEs include hepatotoxicity, QT prolongation, rhabdomyolosis, serious skin rashes (e.g. SJS), edema, acute renal failure, acute hypersensitivity, anemias/neutropenias, excessive weigh gain, retinopathy, vasculitis, among others. The rarity of such drug induced SAEs and the absence of effective government surveillance/research networks, makes it extremely difficult for any one company or research entity to accrue enough SAE cases and controls to conduct effective whole genome studies. Central to the notion of the SAEC is industry, government and health care providers can join forces to make use of a variety of sample and data resources in researching the genetic basis of these events.The purpose of the SAEC is threefold:•To carry out research directed toward the discovery of DNA-variants clinically useful in understanding and predicting the risk of drug induced serious adverse events and similar scientific research.•To ensure the widespread availability of the results of such research to the scientific research community and the public at large for no charge through publication and web-based methods; and•To educate the scientific research and medical

  2. 76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Electrocardiograph Electrodes.'' The special controls identify the following risks to health... Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph...

  3. 77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... thinking on the use of medically important antimicrobial drugs in animal agriculture. DATES: Submit either... the Agency's current thinking on the topic. It does not create or confer any rights for or on...

  4. 77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-27

    ...-Bore Connectors Intended for Enteral Applications; Availability AGENCY: Food and Drug Administration... Misconnections with Small- bore Connectors Intended for Enteral Applications.'' The use of common connector... Risks of Misconnections With Small-Bore Connectors Intended for Enteral Applications'' to the...

  5. 78 FR 55261 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... development and/or testing of generic drug products regarding the requirements and commitments of GDUFA. DATES... launch of the GDUFA program, FDA has revised the draft guidance and is issuing it again in draft...

  6. 76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... Staff; the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications ; Availability... and Drug Administration Staff; The 510(k) Program: Evaluating Substantial Equivalence in Premarket... reviews premarket notification (510(k)) submissions as well as on the Special and Abbreviated...

  7. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-20

    ...; Class II Special Controls; Guidance Document: Topical Oxygen Chamber for Extremities; Availability... Drug Administration Staff; Class II Special Controls Guidance Documents: Topical Oxygen Chamber for... Guidance Document: Topical Oxygen Chamber for Extremities'' to the Division of Small...

  8. Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development-Industry Case Studies.

    PubMed

    Kesisoglou, Filippos; Chung, John; van Asperen, Judith; Heimbach, Tycho

    2016-09-01

    In recent years, there has been a significant increase in use of physiologically based pharmacokinetic models in drug development and regulatory applications. Although most of the published examples have focused on aspects such as first-in-human (FIH) dose predictions or drug-drug interactions, several publications have highlighted the application of these models in the biopharmaceutics field and their use to inform formulation development. In this report, we present 5 case studies of use of such models in this biopharmaceutics/formulation space across different pharmaceutical companies. The case studies cover different aspects of biopharmaceutics or formulation questions including (1) prediction of absorption prior to FIH studies; (2) optimization of formulation and dissolution method post-FIH data; (3) early exploration of a modified-release formulation; (4) addressing bridging questions for late-stage formulation changes; and (5) prediction of pharmacokinetics in the fed state for a Biopharmaceutics Classification System class I drug with fasted state data. The discussion of the case studies focuses on how such models can facilitate decisions and biopharmaceutic understanding of drug candidates and the opportunities for increased use and acceptance of such models in drug development and regulatory interactions.

  9. Academic-industrial relations before the blockbuster drugs: lessons from the Harvard Committee on Pharmacotherapy, 1939-1943.

    PubMed

    Podolsky, Scott H; Greene, Jeremy A

    2011-04-01

    Increasing discussion has developed in recent years over the nature of the relationship between academic medicine and the pharmaceutical industry. This article narrates the history of a little-known attempt at Harvard Medical School between 1939 and 1943 to establish an interdisciplinary, academic-industrial Committee on Pharmacotherapy to enhance and rationalize the relationship between the field of academic research in pharmacotherapeutics and the pharmaceutical industry. Using original archival materials, the authors depict the functioning of the committee, which was headed by Soma Weiss and included such members as Fuller Albright, Henry Beecher, and Walter Cannon. The committee would be collectively funded by seven pharmaceutical companies and was to be predicated on collaboration, both across the entire university and between academia and industry. It was expected to transform the bench-to-bedside study and testing of therapeutic compounds, to redefine the teaching of pharmacotherapy, and to create a unified forum through which to discuss the overall academic-industrial relationship and more specific issues such as patents. Unfortunately, the program proved to be short-lived, the victim of such contingent factors as the untimely death of Soma Weiss and America's entry into World War II, as well as such more fundamental factors as the inadequate and temporary nature of the funding stream and unresolved tensions regarding the goals of the committee on the part of both the medical school and its industry supporters. Nevertheless, these early forays into collaborative bench-to-bedside translational research and the rationalization of academic-industrial relations remain instructive today.

  10. NIMH Initiatives to Facilitate Collaborations between Industry, Academia and Government for the Discovery and Clinical Testing of Novel Models and Drugs for Psychiatric Disorders

    PubMed Central

    Brady, Linda S.; Winsky, Lois; Goodman, Wayne; Oliveri, Mary Ellen; Stover, Ellen

    2008-01-01

    There is an urgent need to transform basic research discoveries into tools for treatment and prevention of mental illnesses. This article presents an overview of the National Institute of Mental Health (NIMH) programs and resources to address the challenges and opportunities in psychiatric drug development starting at the point of discovery through the early phases of translational research. We summarize NIMH and selected National Institutes of Health (NIH) efforts to stimulate translation of basic and clinical neuroscience findings into novel targets, models, compounds, and strategies for the development of innovative therapeutics for psychiatric disorders. Examples of collaborations and partnerships between NIMH/NIH, academia, and industry are highlighted. PMID:18800066

  11. GPCR structure, function, drug discovery and crystallography: report from Academia-Industry International Conference (UK Royal Society) Chicheley Hall, 1-2 September 2014.

    PubMed

    Heifetz, Alexander; Schertler, Gebhard F X; Seifert, Roland; Tate, Christopher G; Sexton, Patrick M; Gurevich, Vsevolod V; Fourmy, Daniel; Cherezov, Vadim; Marshall, Fiona H; Storer, R Ian; Moraes, Isabel; Tikhonova, Irina G; Tautermann, Christofer S; Hunt, Peter; Ceska, Tom; Hodgson, Simon; Bodkin, Mike J; Singh, Shweta; Law, Richard J; Biggin, Philip C

    2015-08-01

    G-protein coupled receptors (GPCRs) are the targets of over half of all prescribed drugs today. The UniProt database has records for about 800 proteins classified as GPCRs, but drugs have only been developed against 50 of these. Thus, there is huge potential in terms of the number of targets for new therapies to be designed. Several breakthroughs in GPCRs biased pharmacology, structural biology, modelling and scoring have resulted in a resurgence of interest in GPCRs as drug targets. Therefore, an international conference, sponsored by the Royal Society, with world-renowned researchers from industry and academia was recently held to discuss recent progress and highlight key areas of future research needed to accelerate GPCR drug discovery. Several key points emerged. Firstly, structures for all three major classes of GPCRs have now been solved and there is increasing coverage across the GPCR phylogenetic tree. This is likely to be substantially enhanced with data from x-ray free electron sources as they move beyond proof of concept. Secondly, the concept of biased signalling or functional selectivity is likely to be prevalent in many GPCRs, and this presents exciting new opportunities for selectivity and the control of side effects, especially when combined with increasing data regarding allosteric modulation. Thirdly, there will almost certainly be some GPCRs that will remain difficult targets because they exhibit complex ligand dependencies and have many metastable states rendering them difficult to resolve by crystallographic methods. Subtle effects within the packing of the transmembrane helices are likely to mask and contribute to this aspect, which may play a role in species dependent behaviour. This is particularly important because it has ramifications for how we interpret pre-clinical data. In summary, collaborative efforts between industry and academia have delivered significant progress in terms of structure and understanding of GPCRs and will be

  12. 76 FR 69274 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-08

    ... Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device... Administration Staff; 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing... comment period to request comments on the draft guidance for industry and FDA staff entitled...

  13. Le lexique anglais-francais de l'industrie miniere de l'Office de la langue francaise (The English-French Lexicon of the Mining Industry prepared by the Office of the French Language)

    ERIC Educational Resources Information Center

    Rousseau, Louis-Jean

    1974-01-01

    This article describes research methods involved in compiling a lexicon of terms used in the mining industry. This consisted mainly in contrasting terms found in dictionaries with actual usage in spoken and written language. (Text is in French) (AM)

  14. Maori English

    ERIC Educational Resources Information Center

    Maclagan, Margaret; King, Jeanette; Gillon, Gail

    2008-01-01

    The Maori language is the language of the indigenous people of New Zealand. Today, not all Maori speak the Maori language, and many Maori as well as non-Maori speak Maori English, the fastest growing of the main varieties of New Zealand English. This paper provides a background to the linguistic situation of the Maori populace in New Zealand,…

  15. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS... draft guidance entitled ``Refuse to Accept Policy for 510(k)s.'' The purpose of this document is to... (510(k)) submission is administratively complete, which determines whether it should be accepted...

  16. 78 FR 24425 - Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Assay Migration Studies for In Vitro Diagnostic Devices...'s current thinking on ``migration studies'' for in vitro diagnostic device. It does not create...

  17. 76 FR 26307 - Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... Applications.'' The guidance is intended to assist abbreviated new drug application (ANDA) applicants in... the Federal Register in January 2009 (74 FR 2849, January 16, 2009). The final rule requires ANDA... subjects: Types of ANDA submissions covered by the regulations on BE studies; Recommended format...

  18. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-19

    ... licensing applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current thinking on... provides sponsors of NDAs, ANDAs, and BLAs CDER's current thinking on appropriate size ranges for beads in...). The draft guidance, when finalized, will represent the Agency's current thinking on size of beads...

  19. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ... Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug... marketing clearance for a new x-ray imaging device with a pediatric indication should provide data... marketing clearance only for general indications or do not submit adequate data to the FDA to support...

  20. Evaluation of CYP2B6 Induction and Prediction of Clinical Drug-Drug Interactions: Considerations from the IQ Consortium Induction Working Group-An Industry Perspective.

    PubMed

    Fahmi, Odette A; Shebley, Mohamad; Palamanda, Jairam; Sinz, Michael W; Ramsden, Diane; Einolf, Heidi J; Chen, Liangfu; Wang, Hongbing

    2016-10-01

    Drug-drug interactions (DDIs) due to CYP2B6 induction have recently gained prominence and clinical induction risk assessment is recommended by regulatory agencies. This work aimed to evaluate the potency of CYP2B6 versus CYP3A4 induction in vitro and from clinical studies and to assess the predictability of efavirenz versus bupropion as clinical probe substrates of CYP2B6 induction. The analysis indicates that the magnitude of CYP3A4 induction was higher than CYP2B6 both in vitro and in vivo. The magnitude of DDIs caused by induction could not be predicted for bupropion with static or dynamic models. On the other hand, the relative induction score, net effect, and physiologically based pharmacokinetics SimCYP models using efavirenz resulted in improved DDI predictions. Although bupropion and efavirenz have been used and are recommended by regulatory agencies as clinical CYP2B6 probe substrates for DDI studies, CYP3A4 contributes to the metabolism of both probes and is induced by all reference CYP2B6 inducers. Therefore, caution must be taken when interpreting clinical induction results because of the lack of selectivity of these probes. Although in vitro-in vivo extrapolation for efavirenz performed better than bupropion, interpretation of the clinical change in exposure is confounded by the coinduction of CYP2B6 and CYP3A4, as well as the increased contribution of CYP3A4 to efavirenz metabolism under induced conditions. Current methods and probe substrates preclude accurate prediction of CYP2B6 induction. Identification of a sensitive and selective clinical substrate for CYP2B6 (fraction metabolized > 0.9) is needed to improve in vitro-in vivo extrapolation for characterizing the potential for CYP2B6-mediated DDIs. Alternative strategies and a framework for evaluating the CYP2B6 induction risk are proposed.

  1. Current Approaches for Absorption, Distribution, Metabolism, and Excretion Characterization of Antibody-Drug Conjugates: An Industry White Paper.

    PubMed

    Kraynov, Eugenia; Kamath, Amrita V; Walles, Markus; Tarcsa, Edit; Deslandes, Antoine; Iyer, Ramaswamy A; Datta-Mannan, Amita; Sriraman, Priya; Bairlein, Michaela; Yang, Johnny J; Barfield, Matthew; Xiao, Guangqing; Escandon, Enrique; Wang, Weirong; Rock, Dan A; Chemuturi, Nagendra V; Moore, David J

    2016-05-01

    An antibody-drug conjugate (ADC) is a unique therapeutic modality composed of a highly potent drug molecule conjugated to a monoclonal antibody. As the number of ADCs in various stages of nonclinical and clinical development has been increasing, pharmaceutical companies have been exploring diverse approaches to understanding the disposition of ADCs. To identify the key absorption, distribution, metabolism, and excretion (ADME) issues worth examining when developing an ADC and to find optimal scientifically based approaches to evaluate ADC ADME, the International Consortium for Innovation and Quality in Pharmaceutical Development launched an ADC ADME working group in early 2014. This white paper contains observations from the working group and provides an initial framework on issues and approaches to consider when evaluating the ADME of ADCs.

  2. Lexicogrammar in the International Construction Industry: A Corpus-Based Case Study of Japanese-Hong-Kongese On-Site Interactions in English

    ERIC Educational Resources Information Center

    Handford, Michael; Matous, Petr

    2011-01-01

    The purpose of this research is to identify and interpret statistically significant lexicogrammatical items that are used in on-site spoken communication in the international construction industry, initially through comparisons with reference corpora of everyday spoken and business language. Several data sources, including audio and video…

  3. ''I'd Love to Put Someone in Jail for This:" An Initial Investigation of English in the Business Processing Outsourcing (BPO) Industry

    ERIC Educational Resources Information Center

    Forey, Gail; Lockwood, Jane

    2007-01-01

    In the global workplace, there has been tremendous growth in business processing outsourcing (BPO). Many industries are establishing call centers, back offices and other offshore enterprises in developing countries in an attempt to reduce costs. This development has far-reaching implications for language in these offshore destinations. Despite…

  4. How to create innovation by building the translation bridge from basic research into medicinal drugs: an industrial perspective.

    PubMed

    Germann, Paul G; Schuhmacher, Alexander; Harrison, Juan; Law, Ronald; Haug, Kevin; Wong, Gordon

    2013-03-05

    The global healthcare industry is undergoing substantial changes and adaptations to the constant decline of approved new medical entities. This decrease in internal research productivity is resulting in a major decline of patent-protected sales (patent cliff) of most of the pharmaceutical companies. Three major global adaptive trends as driving forces to cope with these challenges are evident: cut backs of internal research and development jobs in the western hemisphere (Europe and USA), following the market growth potential of Asia by building up internal or external research and development capabilities there and finally, 'early innovation hunting' with an increased focus on identifying and investing in very early innovation sources within academia and small start-up companies. Early innovation hunting can be done by different approaches: increased corporate funding, establishment of translational institutions to bridge innovation, increasing sponsored collaborations and formation of technology hunting groups for capturing very early scientific ideas and concepts. This emerging trend towards early innovation hunting demands special adaptations from both the pharmaceutical industry and basic researchers in academia to bridge the translation into new medicines which deliver innovative medicines that matters to the patient. This opinion article describes the different modalities of cross-fertilisation between basic university or publicly funded institutional research and the applied research and development activities within the pharmaceutical industry. Two key factors in this important translational bridge can be identified: preparation of both partnering organisations to open up for new and sometime disruptive ideas and creation of truly trust-based relationships between the different groups allowing long-term scientific collaborations while acknowledging that value-creating differences are an essential factor for successful collaboration building.

  5. How to create innovation by building the translation bridge from basic research into medicinal drugs: an industrial perspective

    PubMed Central

    2013-01-01

    The global healthcare industry is undergoing substantial changes and adaptations to the constant decline of approved new medical entities. This decrease in internal research productivity is resulting in a major decline of patent-protected sales (patent cliff) of most of the pharmaceutical companies. Three major global adaptive trends as driving forces to cope with these challenges are evident: cut backs of internal research and development jobs in the western hemisphere (Europe and USA), following the market growth potential of Asia by building up internal or external research and development capabilities there and finally, ‘early innovation hunting’ with an increased focus on identifying and investing in very early innovation sources within academia and small start-up companies. Early innovation hunting can be done by different approaches: increased corporate funding, establishment of translational institutions to bridge innovation, increasing sponsored collaborations and formation of technology hunting groups for capturing very early scientific ideas and concepts. This emerging trend towards early innovation hunting demands special adaptations from both the pharmaceutical industry and basic researchers in academia to bridge the translation into new medicines which deliver innovative medicines that matters to the patient. This opinion article describes the different modalities of cross-fertilisation between basic university or publicly funded institutional research and the applied research and development activities within the pharmaceutical industry. Two key factors in this important translational bridge can be identified: preparation of both partnering organisations to open up for new and sometime disruptive ideas and creation of truly trust-based relationships between the different groups allowing long-term scientific collaborations while acknowledging that value-creating differences are an essential factor for successful collaboration building. PMID

  6. Research and development costs for new drugs by therapeutic category. A study of the US pharmaceutical industry.

    PubMed

    DiMasi, J A; Hansen, R W; Grabowski, H G; Lasagna, L

    1995-02-01

    The clinical period (i.e. clinical trial and long term animal testing) development costs of a random sample of new chemical entities (NCEs) were examined for differences in average cost. All of the NCEs studied were first tested in humans between 1970 and 1982, and were classified for the purposes of the study by therapeutic class. The costs of unsuccessful projects were included with those of projects that resulted in US marketing approval. Including income forgone from expending funds before returns are earned ('time costs'), the capitalised (i.e. out-of-pocket plus time) clinical period costs per approved NCE were $US70, $US98, $US103 and $US163 million (1993 dollars) for anti-infective, cardiovascular, neuropharmacological and nonsteroidal anti-inflammatory drugs, respectively. Combining the data for all therapeutic categories, the mean clinical period cost per approved NCE was $US93 million. Omitting costs associated with unsuccessful projects, the mean capitalised clinical period costs for approved NCEs ranged from $US7.1 million (for topical steroids) to $US66.7 million (for cardiovascular agents) [1993 dollars]. The estimates of total clinical period costs per approved NCE depend on average out-of-pocket clinical phase costs, attrition rates across phases (i.e. the rates at which compounds drop out of active testing), the probability of marketing approval, and development and regulatory review times. Phase attrition and approval rates are the most important sources of variability in total clinical period costs between therapeutic categories. Development cost estimates by therapeutic category did not correlate strongly with US sales in the fifth year of marketing. Cardiovascular NCEs had much higher than average sales revenues, but clinical development costs for these drugs were only slightly above average. Conversely, nonsteroidal anti-inflammatory drugs attained average sales revenues, but had much higher than average development costs.

  7. English Education and Communication Studies: Ambiguity in the International Airway.

    ERIC Educational Resources Information Center

    Aune, Adonica Schultz; Huglen, Mark; Lim, Dan

    In the airline industry, English is now the accepted medium of communication for all air traffic controllers and pilots. For international flights it is of vital importance to hundreds of airline passengers that English be spoken clearly and properly to execute proper procedures and to act decisively and safely. Airspeak, aviation English, or air…

  8. How a patient advocacy group developed the first proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration.

    PubMed

    Furlong, Pat; Bridges, John F P; Charnas, Lawrence; Fallon, Justin R; Fischer, Ryan; Flanigan, Kevin M; Franson, Timothy R; Gulati, Neera; McDonald, Craig; Peay, Holly; Sweeney, H Lee

    2015-06-24

    Among the challenges confronting patients with rare diseases is a dearth of treatment options. The development of safe and effective new therapies is hampered by challenges associated with conducting clinical trials in small populations. In this article, we describe how the Duchenne muscular dystrophy community-led by Parent Project Muscular Dystrophy-created a proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration. This unprecedented undertaking involved a broad coalition of more than 80 stakeholders collaborating across nine time zones to produce a document in only 6 months. We hope that other rare disease communities and advocacy organizations can use our experience as a model for developing their own draft guidance documents.

  9. Complaints, Complainants, and Rulings Regarding Drug Promotion in the United Kingdom and Sweden 2004–2012: A Quantitative and Qualitative Study of Pharmaceutical Industry Self-Regulation

    PubMed Central

    Zetterqvist, Anna V.; Merlo, Juan; Mulinari, Shai

    2015-01-01

    companies were in serious violation more than ten times each. A qualitative content analysis of serious violations pertaining to diabetes drugs (UK, n = 15; Sweden, n = 6; 10% of serious violations) and urologics (UK, n = 6; Sweden, n = 13; 9%) revealed various types of violations: misleading claims (n = 23; 58%); failure to comply with undertakings (n = 9; 23%); pre-licensing (n = 7; 18%) or off-label promotion (n = 2; 5%); and promotion of prescription drugs to the public (n = 6; 15%). Violations that go undetected or unpunished by self-regulatory bodies are the main limitation of this study, since they are likely to lead to an underestimate of industry misconduct. Conclusions The prevalence and severity of breaches testifies to a discrepancy between the ethical standard codified in industry Codes of Conduct and the actual conduct of the industry. We discuss regulatory reforms that may improve the quality of medicines information, such as pre-vetting and intensified active monitoring of promotion, along with larger fines, and giving greater publicity to rulings. But despite the importance of improving regulatory arrangements in an attempt to ensure unbiased medicines information, such efforts alone are insufficient because simply improving oversight and increasing penalties fail to address additional layers of industry bias. PMID:25689460

  10. Black English.

    ERIC Educational Resources Information Center

    Bailey, Charles-James N.

    This paper, presented as part of a military lecture series given by the Division of Continuing Education and Community Service Speakers' Bureau of the University of Hawaii to military personnel at Schofield Barracks and Fort Shafter, investigates the origins and present status of Black English. A discussion of early studies in the Gullah dialect…

  11. English Downfall

    ERIC Educational Resources Information Center

    Theamishaugur

    2009-01-01

    In a remix of the infamous Hitler meme--taking a scene from the movie, "Downfall" (2005), and adding subtitles appropriate (in this case) for "Kairos" readers--theamishaugur makes a pointed, humorous (to some) commentary on the status of multimodal composition scholars in English departments during job market season.

  12. Reduction of multidrug-resistant and drug-susceptible Salmonella in ground beef and freshly harvested beef briskets after exposure to commonly used industry antimicrobial interventions.

    PubMed

    Hughes, M K; Yanamala, S; San Francisco, M; Loneragan, G H; Miller, M F; Brashears, M M

    2010-07-01

    Two separate studies were conducted to examine the differences in survivability of multidrug-resistant (MDR) and drug-susceptible Salmonella in fresh meats in a simulated industry environment. Beef trim from a commercial facility was inoculated with either MDR (AmpC phenotype) or drug-susceptible Salmonella (SUS) cocktails (10(6) CFU/ml). Antimicrobial interventions included 3% lactic acid (LA), 1,000 ppm of acidified sodium chloride (ASC), ambient water (AW), and an inoculated control with no intervention (CTRL). Each aliquot was ground and formed into patties and packaged using high-O(2) modified atmosphere packaging. Samples for microbiological evaluation were collected on days 0, 7, 10, and 14. In the second study, beef briskets were collected immediately after harvest. Inoculation and antimicrobial application were the same, except treatments were heated and there was an additional hot water treatment. All beef briskets were refrigerated, and samples were collected at 0, 6, and 24 h. For the first study, the overall effectiveness of the treatments (from most effective to least effective) was LA, ASC, CTRL, and AW. Significant differences were observed only between MDR and SUS Salmonella when AW was applied (P = 0.02), and bacterial loads with AW were significantly greater (P < 0.01) for MDR Salmonella. In the second study, the intervention effectiveness ranked LA, ASC, hot water, AW, and CTRL. Significant differences between MDR and SUS Salmonella levels were not detected for any intervention or sampling time point. These data indicate that MDR and SUS variants of Salmonella behave similarly in response to the antagonistic action of antimicrobials commonly used in beef facilities.

  13. Who Shall Teach English?

    ERIC Educational Resources Information Center

    Smith, Eugene

    Potential secondary school English teachers undergo a unique screening procedure at the University of Washington. The education faculty allows the English faculty to recommend qualified candidates for the English education program. Students considering teaching English as a career visit the English department's advisory office, where they complete…

  14. A Structural History of English.

    ERIC Educational Resources Information Center

    Nist, John

    This book combines a traditional history-of-the-language approach with modern linguistic analysis to discuss the history of English from Old English through Middle English, Early Modern English, Authoritarian English, Mature Modern English, to American English. The book begins with a discussion of the present status and structure of English. Each…

  15. English Channel

    NASA Technical Reports Server (NTRS)

    1984-01-01

    The cloud covered earthscape of Northern Europe demonstrates the difficulty of photographing this elusive subject from space. The English Channel (51.0N, 1.5E) separating the British Islands from Europe is in the center of the scene. The white cliffs of Dover on the SE coast of the UK, the Thames River estuary and a partial view of the city of London can be seen on the north side of the Channel while the Normandy coast of France is to the south.

  16. What You Should Know about Flu Antiviral Drugs

    MedlinePlus

    ... Newsletters What You Should Know About Flu Antiviral Drugs Language: English Español Recommend on Facebook Tweet ... used to treat flu illness. What are antiviral drugs? Antiviral drugs are prescription medicines (pills, liquid, an ...

  17. Paperwork Plus: Literacy Materials for the Service Industry. Hotel Edition.

    ERIC Educational Resources Information Center

    Bond, Judith; McGill, Teresa

    The instructional materials are intended for use in teaching vocational English and English literacy to limited-English-speaking personnel in the hotel industry. They are designed for learners at three instructional levels, and address job-specific literacy tasks. An introductory section describes the materials and offers suggestions for…

  18. ESL for Hotel/Hospitality Industry. Level: Beginner.

    ERIC Educational Resources Information Center

    Western Suffolk County Board of Cooperative Educational Services, Northport, NY.

    This document contains eight lesson plans for a beginning course in work-related English for non-English or limited-English speaking entry-level employees in the hotel and hospitality industry. Course objectives include the following: helping participants understand and use job-specific vocabulary; receive and understand job-related instructions;…

  19. Plain English Helps the Financial Services Industry.

    ERIC Educational Resources Information Center

    McGrath, Matthew J.

    1987-01-01

    In examining documentation difficulties through user surveys, Citibank found that their many different accounts each had unique forms, and accounts were booked in different locations and currencies. New forms emerged with new types of accounts. Refinement efforts reduced the number of forms from 64 to 4. (Author/CH)

  20. English Vocabulary Instruction for English Learners

    ERIC Educational Resources Information Center

    Manyak, Patrick C.; Bauer, Eurydice Bouchereau

    2009-01-01

    In this column Manyak and Bauer summarize key research addressing the English vocabulary development of English learners (ELs) and distill implications for instructional practice. First, the authors discuss several key studies that demonstrate the limitation of many ELs' English vocabulary knowledge and the negative impact of this limitation on…

  1. English as "Tyrannosaurus Rex."

    ERIC Educational Resources Information Center

    Swales, John M.

    1997-01-01

    The increasing domination of English as the world's leading medium of international professional communication has begun to impact English for Academic Purposes (EAP) programs, specifically the question of whether English is becoming too successful. The article argues that resistance to the "triumphalism" of English is a responsibility of EAP…

  2. English Teaching Profile: France.

    ERIC Educational Resources Information Center

    British Council, London (England). English Language and Literature Div.

    This review of the status of English language instruction in France provides an overview of the role of English in the society in general and outlines the status of English in the educational system at the elementary, secondary, higher, and vocational levels. The following topics are covered: instruction in English for special purposes, the…

  3. The "New" English.

    ERIC Educational Resources Information Center

    DeBoer, John J.

    1968-01-01

    Recent trends in the English curriculum--little more than changes in emphases--do not constitute a utopian "new English." In fact, one trend, revealed in some current studies of the high school English curriculum, involves a return to the "old" tradition of instruction in the great masters of English and American literature. The studies imply a…

  4. English Teaching Profile: Yugoslavia.

    ERIC Educational Resources Information Center

    British Council, London (England). English Language and Literature Div.

    A review of the status of English language instruction in Yugoslavia begins with an overview of the role of English in the society in general and outlines the status of English use and instruction in the educational system at all levels. The review also covers the characteristics and training of English language instructors, the type and…

  5. English Teaching Profile: Mexico.

    ERIC Educational Resources Information Center

    British Council, London (England). English Language and Literature Div.

    This profile of the English language teaching situation in Mexico examines the role of English in society and in the educational system. It is noted that the extent to which English is used in Mexico is affected by the country's proximity to the United States. The educational system is described, with emphasis on English instruction which begins…

  6. English Teaching Profile: Senegal.

    ERIC Educational Resources Information Center

    British Council, London (England). English Language and Literature Div.

    This profile of the English language teaching situation in Senegal examines the role of English in society and in the educational system. It is noted that English is the principal foreign language studied, but that it is used very little as a means of communication. The English curriculum is described, especially the secondary school examinations,…

  7. English Teaching Profile: Ethiopia.

    ERIC Educational Resources Information Center

    British Council, London (England).

    A review of the status of English language instruction in Ethiopia begins with an overview of the role of English in the society in general, and goes on to outline the status of English use and instruction in the educational system at all levels (elementary, secondary, higher, and teacher), the characteristics and training of English language…

  8. On Observing World English.

    ERIC Educational Resources Information Center

    Urdang, Lawrence

    1990-01-01

    Reviews the current state of World English. Subjects addressed include standard accents and dialects, prejudicial attitudes toward nonstandard "local" usages, the use of English as the language of diplomacy, American influences on the language, and the fracturing of English in non-English-speaking countries around the world. (17 references) (JL)

  9. ENGLISH AND THE DISADVANTAGED.

    ERIC Educational Resources Information Center

    FAGAN, EDWARD R., ED.

    PART 1 OF THIS COLLECTION OF ARTICLES BY THE STAFF AND PARTICIPANTS OF AN NDEA SUMMER INSTITUTE IN ENGLISH FOR DISADVANTAGED YOUTH DESCRIBES ATTITUDES AND VIEWPOINTS ON THE PLACE OF ENGLISH IN THE DAILY LIVES OF STUDENTS AND CONTAINS ARTICLES ON "ENGLISH FOR WHAT" BY CHARLES WEINGARTNER, "ENGLISH TEACHING AND DROP-OUTS" AND…

  10. Catching Up with Europe: Speakers and Functions of English in Hungary.

    ERIC Educational Resources Information Center

    Petzold, Ruth; Berns, Margie

    2000-01-01

    Discusses the functional range of English and its penetration into Hungarian society and shows that in just a few years English has become an essential tool for modernization and economic development and a significant medium in the tourist and entertainment industries as well as education. The need for and use of English in the workplace has had a…

  11. Concept of Best Practices in English Language Teaching to Pakistani ELT Fraternity

    ERIC Educational Resources Information Center

    Soomro, Muhammad Arif; Memon, Natasha; Memon, Shumaila Aijaz

    2016-01-01

    Teaching industry of English as a second or foreign language has grown massively in recent times in Pakistan. There are many public sectors universities and English academies established all over Pakistan offering English language proficiency courses. Therefore, this wave led to conduct this research. The purpose of conducting this study was to…

  12. Is the Drug Problem Soluble?

    ERIC Educational Resources Information Center

    Jonas, Steven

    1989-01-01

    Concludes that the principle drug problems in the United States arise from the use of cigarette tobacco and alcoholic beverages. Identifies a drug culture as the persistent force in society that promotes drug use. Points out that the influence of the primary drug industries inhibit attempts to deal effectively with drug problems. (KO)

  13. Energy-Saving Opportunities for Manufacturing Companies (English/Portuguese Brochure)

    SciTech Connect

    Not Available

    2011-07-01

    This English/Portuguese brochure describes the Industrial Technologies Program Save Energy Now model and provides information on tools and resources to help manufacturing facilities reduce industrial energy intensity.

  14. Energy-Saving Opportunities for Manufacturing Companies, (English/Russian Fact Sheet) (Revised)

    SciTech Connect

    Not Available

    2011-07-01

    This English/Russian brochure describes the Industrial Technologies Program Save Energy Now model and provides information on tools and resources to help manufacturing facilities reduce industrial energy intensity.

  15. 21 CFR 803.13 - Do I need to submit reports in English?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Do I need to submit reports in English? 803.13... need to submit reports in English? (a) Yes. You must submit all written or electronic equivalent reports required by this part in English. (b) If you submit any reports required by this part in...

  16. 21 CFR 803.13 - Do I need to submit reports in English?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Do I need to submit reports in English? 803.13... in English? (a) Yes. You must submit all written or electronic equivalent reports required by this part in English. (b) If you submit any reports required by this part in an electronic medium,...

  17. 21 CFR 803.13 - Do I need to submit reports in English?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Do I need to submit reports in English? 803.13... in English? (a) Yes. You must submit all written or electronic equivalent reports required by this part in English. (b) If you submit any reports required by this part in an electronic medium,...

  18. 21 CFR 803.13 - Do I need to submit reports in English?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Do I need to submit reports in English? 803.13... in English? (a) Yes. You must submit all written or electronic equivalent reports required by this part in English. (b) If you submit any reports required by this part in an electronic medium,...

  19. Dictionary of surfactants English/German and German/English

    SciTech Connect

    Siekmann, K.

    1987-01-01

    This dictionary is supplement to the monograph ''Surfactants in Consumer Products'' edited by Professor Dr. J. Falbe. It comprises approximately 3.200 keywords of the chemistry, technology and applications of surfactants in English/German and German/English. In the monograph the physical-chemical principles of action of the surfactants, their production and their application in laundry detergents, dishwashing detergents and cleaning agents as well as in cosmetics and toiletries are discussed. The technological aspects of application and formulation along with those of production and manufacturing processes are illustrated. Ecological and toxicological questions are probed in depth. Finally, important economic data concerning this branch of industry as well as an attempt to provide a perspective with regard to the future of the surfactant market round out the picture.

  20. Tussle Over English-Language Learners

    ERIC Educational Resources Information Center

    Zehr, Mary Ann

    2007-01-01

    In the past decade, Harrisonburg, Virginia, has become a magnet for immigrant families drawn to jobs in the poultry and construction industries. More than 1,600 of the school district's 4,400 students are English-learners. The largest group of newcomers are Latinos, followed by Kurdish and Russian refugees. In this article, the author discusses a…

  1. English Language Teaching in Indonesia.

    ERIC Educational Resources Information Center

    Musthafa, Bachrudin

    2002-01-01

    Discusses the education system in Indonesia, the development of a national English syllabus, English in elementary and secondary schools and in higher education, private sector English courses, teacher preparation and professional development, and expatriate English teachers. (Author/VWL)

  2. On the Applications of Modern Educational Technology in Maritime English Teaching from the Perspective of Constructivism

    ERIC Educational Resources Information Center

    Cui, Zhongliang

    2010-01-01

    Nowadays maritime transportation has become a major modern logistics because of its large capacity and low cost. English plays a leading role in the industry of maritime transportation. It is the most important medium and an indispensable communication tool in international business and global marine industry. Maritime English teaching has made…

  3. An Empirical Report on an English for Special Purposes Learning Situation.

    ERIC Educational Resources Information Center

    Hickey, Joseph

    One teacher's experience in providing individualized instruction in English to a manager in the German coal mining industry is reported. The highly motivated manager required specialized skills in English for communicating with foreign visitors who were either members of the industry or lay people. The manager brought with him to the first meeting…

  4. A Handbook of the Job-Site English Project 1985-86.

    ERIC Educational Resources Information Center

    Acevedo, Sheila; Dovel, Frankie

    The Orange County Public Schools' Job Site English Project was initiated to provide employees of businesses and industries with work-related English for speakers of other languages. The program features individualized curricula that are developed after the curriculum writer visits the business/industry in need of services, analyzes the…

  5. Risk evaluation and mitigation strategies for drugs with abuse liability: public interest, special interest, conflicts of interest, and the industry perspective.

    PubMed

    Wright, Curtis; Schnoll, Sidney; Bernstein, David

    2008-10-01

    Risk evaluation and mitigation strategies (REMS) formerly known as Risk Minimization Action Plans (RiskMAPs) are a regulatory technique for dealing with anticipated risks of new medications and are especially important for new drugs with abuse potential. This paper describes the origin and history of risk-management plans for drugs that might be abused, the proper use of these plans in minimizing the risk to the public, and the special difficulties inherent in managing risks for drugs with abuse potential. Drugs with abuse liability are distinctive since the risks inherent in manufacture and distribution include not only risks to patients prescribed the medications, but also risks to the general public including subgroups in the population not intended to get the drug and who receive no medical benefit from the medication. The crafting of risk-management plans intended to protect nonpatient populations is unique for these products. The content, extent, and level of intensity of these plans affect areas of medical ethics, civil liability, and criminal prosecution. The need for risk-management plans for drugs with abuse liability can potentially act as a deterrent to investment and is a factor in decisions concerning the development of new medications for the treatments of pain, ADHD, anxiety disorders, and addictions. This paper provides a framework for moving the process of REMS development forward and criteria for evaluating the probity and adequacy of such programs.

  6. English Language Teaching Profile: Spain.

    ERIC Educational Resources Information Center

    British Council, London (England). English Language and Literature Div.

    The role of English in Spain is discussed, with attention directed to (1) English within the educational system, (2) inspection of teachers and teaching methods, (3) commercial English, (4) adult education, (5) radio and television instruction in English, (6) English teachers, (7) English outside the educational system, and (8) British and…

  7. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2001-01-01

    An overview of the industrial diamond industry is provided. More than 90 percent of the industrial diamond consumed in the U.S. and the rest of the world is manufactured diamond. Ireland, Japan, Russia, and the U.S. produce 75 percent of the global industrial diamond output. In 2000, the U.S. was the largest market for industrial diamond. Industrial diamond applications, prices for industrial diamonds, imports and exports of industrial diamonds, the National Defense Stockpile of industrial diamonds, and the outlook for the industrial diamond market are discussed.

  8. English Transported: Essays on Australasian English.

    ERIC Educational Resources Information Center

    Ramson, W. S., Ed.

    This collection of essays on Australasian English deals with various aspects of the language as it is spoken in the areas of Australian, New Zealand, and Papua-New Guinea. Although the bulk of the essays are concerned with Australian and New Zealand English, the editor expresses the hope that the integrated study of these two major dialects will…

  9. An ecological perspective on U.S. industrial poultry production: the role of anthropogenic ecosystems on the emergence of drug-resistant bacteria from agricultural environments.

    PubMed

    Davis, Meghan F; Price, Lance B; Liu, Cindy Meng-Hsin; Silbergeld, Ellen K

    2011-06-01

    The industrialization of food animal production, specifically the widespread use of antimicrobials, not only increased pressure on microbial populations, but also changed the ecosystems in which antimicrobials and bacteria interact. In this review, we argue that industrial food animal production (IFAP) is appropriately defined as an anthropogenic ecosystem. This paper uses an ecosystem perspective to frame an examination of these changes in the context of U.S. broiler chicken production. This perspective emphasizes multiple modes by which IFAP has altered microbiomes and also suggests a means of generating hypotheses for understanding and predicting the ecological impacts of IFAP in terms of the resistome and the flow of resistance within and between microbiomes.

  10. English in Mauritius.

    ERIC Educational Resources Information Center

    Foley, Joseph

    1995-01-01

    Provides an overview of the position of English on the island of Mauritius, where the dominant language of the home is a French-based Creole but the language of government and schooling is English. Also discusses English instruction on Mauritius, noting that language instruction on the island has been traditionally structuralist rather than…

  11. Aboriginal English. PEN 93.

    ERIC Educational Resources Information Center

    Eades, Diana

    This report focuses on the teaching of English to Aboriginal children in primary schools in Australia. A definition and analysis of dialectal differences between Aboriginal (Australian) English and Standard (Australian) English is offered that includes the phonological, morpho-syntactic, lexico-semantic, and pragmatic differences of the Aboriginal…

  12. English Teaching Profile: Brazil.

    ERIC Educational Resources Information Center

    British Council, London (England). English Language and Literature Div.

    This review of the status of English language instruction in Brazil provides an overview of the Brazilian geographic, historical, and political context and the role of English in the society in general and in the educational system. The following topics are covered: an outline of the status of English use and instruction in the educational system…

  13. English Teaching Profile: Algeria.

    ERIC Educational Resources Information Center

    British Council, London (England). English Language and Literature Div.

    A survey of the status and use of the English language in Algeria is presented. The following topics are outlined: (1) the role of English as a third language, (2) its place within the educational system at all levels and in each graduate institution, (3) the status of British expatriates teaching English in Algeria and of Algerian teachers of…

  14. China's English Language Environment

    ERIC Educational Resources Information Center

    Gil, Jeffrey

    2008-01-01

    Chinese students and teachers often say that the major challenge they face in acquiring English is that "China does not have a good English language environment" ("zhong guo de ying yu huan jing bu tai hao") by which they mean there are insufficient opportunities to use English in real life situations and a lack of exposure to…

  15. My English History.

    ERIC Educational Resources Information Center

    Sommer, Paul

    2003-01-01

    Outlines the author's history as an English teacher. Suggests that English teaching is not hermetic but profoundly influenced by educational trends outside the subject itself. Explains that the author's commitment to English combines a sense of engagement with a sense of liberation. (PM)

  16. English and the Arts.

    ERIC Educational Resources Information Center

    Mead, Russell

    1968-01-01

    English, which enrolls all students, is the only humanities course capable of transmitting culture to everyone. Students respond to cultural stimuli other than books, however; and since many justifications for traditionally narrow English courses are demonstrably not valid, English subject matter should be broadened to include methods of…

  17. English in China.

    ERIC Educational Resources Information Center

    Dzau, Y. F.; And Others

    This collection of writings on the history and status of English language teaching (ELT) in China includes the following essays: "Historical Background" (Y. F. Dzau); "How English is Taught in Tertiary Educational Institutions" (Dzau); "Teaching English in Chinese Secondary Schools" (Yu Yining); "Teachers,…

  18. English in Vanuatu.

    ERIC Educational Resources Information Center

    Crowley, Terry

    1989-01-01

    Although English shares official language status with French in Vanuatu, enrollments in English-language schools have increased dramatically at the expense of French-medium schools. Bislama, an English-derived pidgin, has become a compromise language between the two colonial languages that have divided the country. (Author/CB)

  19. Business English: Curriculum Guide.

    ERIC Educational Resources Information Center

    Montag, Elizabeth J.; Shaw, Warren

    Intended as an English elective subject for senior high school students, this business English course guide provides students with the communication tools that can lead to success in the business world. Units cover the following topics: introduction to Business English (punctuation, grammar, spelling, vocabulary, and use of reference tools);…

  20. Moodling English Language Education

    ERIC Educational Resources Information Center

    Coskun, Abdullah; Arslan, Abdullah

    2014-01-01

    This paper aims to emphasize the importance of using Moodle in foreign language learning and teaching by reviewing relevant literature and introducing a Moodle-based environment aiming to help English learners to practice their English by themselves. Firstly, the use of Moodle in education and more specifically in English Language Teaching is…

  1. Noch Einmal:American English - British English (Once More: American English -- British English).

    ERIC Educational Resources Information Center

    Botts, M.

    1980-01-01

    Replies critically to the article by D. K. Stevenson and R. J. Brunt, "Living English: Seeing the Forest in Spite of the Trees -- On Differences between American English and British English," in this journal, issue 1979/2. A reply by Stevenson and Brunt continues the controversy. (IFS/WGA)

  2. English Teaching in Mexico.

    ERIC Educational Resources Information Center

    Salazar, Denise

    2002-01-01

    Discusses teaching English in Mexico, a country with important social, cultural, and economic ties to the United States. Looks at the various English teaching situations as well as teacher education for teachers in Mexico. Concludes that the English teaching situation in Mexico reflects great diversity and growth, and that the knowledge of English…

  3. Sentential Negation in English

    ERIC Educational Resources Information Center

    Mowarin, Macaulay

    2009-01-01

    This paper undertakes a detailed analysis of sentential negation in the English language with Chomsky's Government-Binding theory of Transformational Grammar as theoretical model. It distinguishes between constituent and sentential negation in English. The essay identifies the exact position of Negation phrase in an English clause structure. It…

  4. 78 FR 100 - Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ...; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled ``Refuse to Accept Policy for 510(k)s.'' The purpose of this document is to explain the procedures and criteria FDA intends to use in determining whether a 510(k) submission is...

  5. Industrial garnet

    USGS Publications Warehouse

    Olson, D.W.

    2001-01-01

    A general overview of the industrial garnet industry is provided. About 20 percent of global industrial garnet production takes place in the U.S. During 2000, an estimated 300 kt of industrial garnets were produced worldwide. The U.S. is the world's largest consumer of industrial garnet, consuming 56.9 kt in 2000.

  6. China's growing biomedical industry.

    PubMed

    Han, Pei

    2009-06-01

    The biomedical industry in China is developing rapidly, and new biological drugs are increasing their share of the pharmaceutical market based on people's needs. China is the largest producer and user of vaccines in the world, but the existing production of vaccines is far from enough to meet the needs of the market. The entire market of biological drugs in China is still smaller than that for traditional medicines and chemicals. Therefore, the biopharmaceutical industry has the potential to be the rising star in the pharmaceutical market in the future.

  7. English as Lingua Franca and English in Europe

    ERIC Educational Resources Information Center

    Berns, Margie

    2009-01-01

    One of the objectives of English as Lingua Franca (ELF) researchers is an account of the unique features of English that they have found in the speech of European users of English. These features, it is argued, describe a variety of English which they label "English as Lingua Franca". The choice of this particular term is problematic…

  8. General English Ability, Specific Purpose English Ability, and Computer Skills.

    ERIC Educational Resources Information Center

    Prapphal, Kanchana

    2003-01-01

    Aims to answer the following research questions: (1) Are general English ability and specific purpose English ability related to computer skills? and (2) Is general English ability transferable to specific purpose English ability? Subjects were third year science students enrolled in an English for academic purposes course. (Author/VWL)

  9. Food and Drug Administration

    MedlinePlus

    ... Reportable Food Registry Report an Emergency Report Suspected Criminal Activity For Industry: Drugs and Therapeutic Biologics News & ... FDA Organization FDA Basics Advisory Committees International Programs Criminal Investigations Emergency Preparedness & Response Working at FDA Training/ ...

  10. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2003-01-01

    Statistics on the production, consumption, cost, trade, and government stockpile of natural and synthetic industrial diamond are provided. The outlook for the industrial diamond market is also considered.

  11. Thanking Responders in Cameroon English

    ERIC Educational Resources Information Center

    Ouafeu, Yves Talla Sando

    2009-01-01

    An analysis of authentic or genuine interactions among Cameroon English speakers reveals that conversational routines in this variety of English differ a good deal from those obtained in other varieties of English, non-native varieties of English inclusive, and more specifically in native varieties of English. This paper looks at "thanking…

  12. English Teaching Profile (Provisional): Germany.

    ERIC Educational Resources Information Center

    British Council, London (England). English Language and Literature Div.

    The role and status of English instruction in West Germany is outlined. The regions of West Berlin, Hesse, and North Rhine-Westphalia are highlighted. The role of English and English instruction in the country as a whole, English instruction in the educational system, the demand for and qualifications of English teachers, textbook selection and…

  13. ESL for Hotel/Hospitality Industry. Level: Advanced Beginner/Intermediate.

    ERIC Educational Resources Information Center

    Western Suffolk County Board of Cooperative Educational Services, Northport, NY.

    This document contains 16 lesson plans for an advanced beginning and intermediate course in work-related English for non-English- or limited-English-speaking entry-level employees in the hotel and hospitality industry. Course objectives are as follows: helping participants understand and use job-specific vocabulary; receive and understand…

  14. Industrial Minerals

    ERIC Educational Resources Information Center

    Bradbury, James C.

    1978-01-01

    The past year is seen as not particularly good for industrial minerals and for industry in general. Environmental concerns continued to trouble the industry with unacceptable asbestos concentrations and chlorofluorocarbon effects on ozone. A halting U.S. economy also affected industrial progress. (MA)

  15. Industry Employment

    ERIC Educational Resources Information Center

    Occupational Outlook Quarterly, 2012

    2012-01-01

    This article illustrates projected employment change by industry and industry sector over 2010-20 decade. Workers are grouped into an industry according to the type of good produced or service provided by the establishment for which they work. Industry employment projections are shown in terms of numeric change (growth or decline in the total…

  16. INTERNATIONAL ENGLISH MANUAL

    SciTech Connect

    AMADOR, MABLE; KELLER, YVONNE KELLER

    2002-02-22

    This document presents a set of guidelines for authors who wish to express themselves more clearly to foreign readers, or readers whose first language is not American English. Topics include idioms, technical terms, jargon, word meaning, acronyms, and international conventions of measurement. The guidelines will help writers of technical documents present their ideas more effectively to audiences that may include individuals whose first language is not American English, including audiences with individuals from other English-speaking countries.

  17. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2000-01-01

    Part of the 1999 Industrial Minerals Review. A review of the state of the global industrial diamond industry in 1999 is presented. World consumption of industrial diamond has increased annually in recent years, with an estimated 500 million carats valued between $650 million and $800 million consumed in 1999. In 1999, the U.S. was the world's largest market for industrial diamond and was also one of the world's main producers; the others were Ireland, Russia, and South Africa. Uses of industrial diamonds are discussed, and prices of natural and synthetic industrial diamond are reported.

  18. Drug discovery in jeopardy

    PubMed Central

    Cuatrecasas, Pedro

    2006-01-01

    Despite striking advances in the biomedical sciences, the flow of new drugs has slowed to a trickle, impairing therapeutic advances as well as the commercial success of drug companies. Reduced productivity in the drug industry is caused mainly by corporate policies that discourage innovation. This is compounded by various consequences of mega-mergers, the obsession for blockbuster drugs, the shift of control of research from scientists to marketers, the need for fast sales growth, and the discontinuation of development compounds for nontechnical reasons. Lessons from the past indicate that these problems can be overcome, and herein, new and improved directions for drug discovery are suggested. PMID:17080187

  19. The Importance of Foreign Language Education to the Hospitality Industry.

    ERIC Educational Resources Information Center

    Kluge, E. Alan

    In the hospitality industry there are three major needs for study of a foreign language: (1) the need to communicate with non-English speaking employees, (2) the need to assist foreign travelers; and (3) the need to work in a non-English speaking country. The strength of the need to know a foreign language depends on the employee's level within…

  20. The relationship between rational drug design and drug side effects.

    PubMed

    Wang, Juan; Li, Zhi-xin; Qiu, Cheng-xiang; Wang, Dong; Cui, Qing-hua

    2012-05-01

    Previous analysis of systems pharmacology has revealed a tendency of rational drug design in the pharmaceutical industry. The targets of new drugs tend to be close with the corresponding disease genes in the biological networks. However, it remains unclear whether the rational drug design introduces disadvantages, i.e. side effects. Therefore, it is important to dissect the relationship between rational drug design and drug side effects. Based on a recently released drug side effect database, SIDER, here we analyzed the relationship between drug side effects and the rational drug design. We revealed that the incidence drug side effect is significantly associated with the network distance of drug targets and diseases genes. Drugs with the distances of three or four have the smallest incidence of side effects, whereas drugs with the distances of more than four or smaller than three show significantly greater incidence of side effects. Furthermore, protein drugs and small molecule drugs show significant differences. Drugs hitting membrane targets and drugs hitting cytoplasm targets also show differences. Failure drugs because of severe side effects show smaller network distances than approved drugs. These results suggest that researchers should be prudent on rationalizing the drug design. Too small distances between drug targets and diseases genes may not always be advantageous for rational design for drug discovery.

  1. Towards Developmental World Englishes

    ERIC Educational Resources Information Center

    Bolton, Kingsley; Graddol, David; Meierkord, Christiane

    2011-01-01

    Over the last three decades scholars promoting the world Englishes paradigm (WE) have worked towards establishing a more positive attitude towards international varieties of English. However, despite the best intentions of Western linguists working in this field, there is an obvious imbalance between the developed and developing world in many…

  2. California's English Learner Students

    ERIC Educational Resources Information Center

    Hill, Laura E.

    2012-01-01

    English Learner (EL) students in California's schools are numerous and diverse, and they lag behind their native-English-speaking peers. Closing the achievement gap for EL students has been a long-standing goal for California educators, and there are some signs of success. Now that EL funding and curriculum issues are receiving a fresh level of…

  3. Reshaping High School English.

    ERIC Educational Resources Information Center

    Pirie, Bruce

    This book takes up the question of what shape high school English studies should take in the coming years. It describes an English program that blends philosophical depth with classroom practicality. Drawing examples from commonly taught texts such as "Macbeth,""To Kill a Mockingbird," and "Lord of the Flies," the…

  4. English for Global Peacekeeping

    ERIC Educational Resources Information Center

    Crossey, Mark

    2008-01-01

    In this article, I discuss the work of the British Council's Peacekeeping English Project: why the British Council is undertaking this work, why is it being sponsored, what exactly is being done and what are the key issues in English for peacekeeping and other security forces.

  5. English I. [Revised].

    ERIC Educational Resources Information Center

    Spann, Margaret; And Others

    This manual for language arts instructors contains a basic core of instruction in English that provides updated and extensive vocationally related application of such basic English skills as reading, writing, and practical usage. Attention is also focused on assisting students with life and study skills. The material should be adapted to…

  6. English "Si," Only "No."

    ERIC Educational Resources Information Center

    Villanueva, Victor, Jr.

    The English-only movement is about more than language; underlying it is bigotry against non-White, non-English-speaking immigrants. The term "Hispanic" is itself a Census Bureau creation which ignores the cultural and linguistic differences between such groups as the Mexican, Cuban, and Nicaraguan immigrants. The argument that a single…

  7. Abbreviations in Maritime English

    ERIC Educational Resources Information Center

    Yang, Zhirong

    2011-01-01

    Aiming at the phenomena that more and more abbreviations occur in maritime English correspondences, the composing laws of the abbreviations in maritime English correspondence are analyzed, and the correct methods to answer the abbreviations are pointed out, and the translation method of abbreviations are summarized in this article, and the…

  8. Learning English, Learning Science

    ERIC Educational Resources Information Center

    Nelson, Virginia

    2010-01-01

    Using science notebooks effectively in the classroom can encourage students who are learning English to keep up and keep interested. English language proficiency might head the list of content areas that schools can teach properly and effectively through science. Amaral, Garrison, and Klentschy (2002) reported that a successful inquiry-based…

  9. Coordinate Structures in English.

    ERIC Educational Resources Information Center

    Meyer, Charles F.

    1996-01-01

    Examines comparable speech and writing samples in the British and American components of the International Corpus of English (ICE) to study properties of coordinate structures in English. Findings indicate that "and" is a primary coordinator, that "but" and "or" are more peripheral, and that the concept of…

  10. English Loanwords in Russian.

    ERIC Educational Resources Information Center

    Benson, Morton

    1959-01-01

    This introductory survey describes the English contribution to the vocabulary of modern Russian. The author presents an analysis of English loanwords based on the etymologies of Vasmer and Lexin, by subject classification (amusements, clothing, economics, food, nautical terminology, and technology). Separate commentary on sporting terms, where…

  11. English and "Humanities"

    ERIC Educational Resources Information Center

    Lindley, David

    1973-01-01

    Defends English instruction against the current trend of integrating such classes into humanities programs, arguing for the uniqueness and unpredictability of all experience and the human capacity to recreate, share, and evaluate experience as is taught in English. (Author/RB)

  12. Lexicon of Black English.

    ERIC Educational Resources Information Center

    Dillard, J. L.

    The purpose of this volume is to demonstrate that the fields of linguistics, dialectology, language education, and early reading would be well served by a word book of the Black English vernacular. Chapters are devoted to discussion of the social significance of a lexicon of Black English vernacular, the terminology of sex and lovemaking, religion…

  13. English in Myanmar

    ERIC Educational Resources Information Center

    Fen, Wong Soon

    2005-01-01

    This paper provides an overview of the development of English in Myanmar. It begins by tracing the changing role and status of English and Myanmar from the colonial period, which has had an impact on the current education structure. The paper outlines the structure of the education system and the recent reforms that reflect the rising importance…

  14. ENGLISH LANGUAGE ARTS EDUCATION.

    ERIC Educational Resources Information Center

    SQUIRE, JAMES R.

    IN THE PAST DECADE, ENGLISH AS A SCHOOL SUBJECT HAS BEEN REASSESSED TO ESTABLISH PRIORITIES, SPECIFY THE TASKS OF THE ENGLISH TEACHER, AND CREATE EFFECTIVE SEQUENTIAL, INTEGRATED PROGRAMS WHICH BALANCE CONTENT AND SKILLS. THIS SUMMARY REPORT CONSIDERS EMERGING CONCEPTS IN THE TEACHING OF LANGUAGE, LITERATURE, AND COMPOSITION, AND THEIR APPLICATION…

  15. English in Indian Media.

    ERIC Educational Resources Information Center

    Khubchandani, Lachman M.

    2000-01-01

    Examines the use of English in urban India, with specific focus on the three domains of mass media, print, television, and advertising. Points to the emergence of Angrezi, which can potentially take a divergent path as an Ausbau language different from the global English. Brings under discussion interesting examples of bilingual and biscriptal…

  16. English for Business Communication

    ERIC Educational Resources Information Center

    Bhatia, Vijay K.; Bremner, Stephen

    2012-01-01

    The concept of Business English has undergone some major shifts in the last few years because of a number of developments, such as advances in genre theory and the coming together of English for Business Purposes and Business Communication, inspired by the realization that there is a gap to be bridged between the academy and the globalized…

  17. Scientific and Technical English.

    ERIC Educational Resources Information Center

    Vaclavik, Jaroslav

    Technical English differs from everyday English because of the specialized contexts in which it is used and because of the specialized interests of scientists and engineers. This text provides exercises in technical and scientific exposition in the following fields: mathematics, physics, temperature effects, mechanics, dynamics, conservation of…

  18. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2004-01-01

    Part of the 2003 industrial minerals review. Supply and demand data for industrial diamond are provided. Topics discussed are consumption, prices, imports and exports, government stockpiles, and the outlook for 2004.

  19. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2012-01-01

    Estimated 2011 world production of natural and synthetic industrial diamond was about 4.45 billion carats. During 2011, natural industrial diamonds were produced in more than 20 countries, and synthetic industrial diamond was produced in at least 13 countries. About 98 percent of the combined natural and synthetic global output was produced in China, Ireland, Japan, Russia, South Africa and the United States. China is the world's leading producer of synthetic industrial diamond followed by Russia and the United States.

  20. English Learners: Reaching the Highest Level of English Literacy.

    ERIC Educational Resources Information Center

    Garcia, Gilbert C., Ed.

    This collection of papers examines the critical literacy development of English learners, focusing on English reading instruction in an immersion setting, English language development, and cultural issues pertaining to English learners in and out of the classroom. The 16 papers include the following: (1) "Reading and the Bilingual Student: Fact…

  1. Learner Views on English and English Language Teaching in China

    ERIC Educational Resources Information Center

    Liu, Na; Lin, Chih-Kai; Wiley, Terrence G.

    2016-01-01

    Since the 1980s, China has represented one of the major growth areas in the world for English language education, and studying English has been a priority among its foreign language educational policies. As English has gained more popularity in China, some have noted the potential value of English as a means to greater educational access and…

  2. Constructing English as a Ugandan Language through an English Textbook

    ERIC Educational Resources Information Center

    Stranger-Johannessen, Espen

    2015-01-01

    English is a national language in Uganda and is widely used in elite areas such as politics and business, but most Ugandans master English to only a limited degree. In this situation, English can be seen as either a foreign language or a second language--influencing how English is taught. One goal of language teaching espoused in this article is…

  3. Industrial Microbiology.

    ERIC Educational Resources Information Center

    Demain, Arnold L.; Solomon, Nadine A.

    1981-01-01

    Presents an overview of the field of industrial microbiology, providing historical backgrounds of scientific discoveries in the field and descriptions of industrially important microorganisms. Applied research in industry is also detailed, with mention of gene amplification, DNA recombination, pharmaceutical approaches, and detoxification and…

  4. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2011-01-01

    Estimated world production of natural and synthetic industrial diamond was about 4.44 billion carats in 2010. Natural industrial diamond deposits have been found in more than 35 countries, and synthetic industrial diamond is produced in at least 15 countries.

  5. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2006-01-01

    In 2005, estimated world production of natural and synthetic industrial diamond was 630 million carats. Natural industrial diamond deposits were found in more than 35 countries. Synthetic industrial diamond is produced in at least 15 countries. More than 81% of the combined natural and synthetic global output was produced in Ireland, Japan, Russia, South Africa and the United States.

  6. Industry Employment

    ERIC Educational Resources Information Center

    Occupational Outlook Quarterly, 2010

    2010-01-01

    This article illustrates projected employment change from an industry perspective over the 2008-2018 decade. Workers are grouped into an industry according to the type of good produced or service provided by the establishment in which they work. Industry employment projections are shown in terms of numeric change (growth or decline in the total…

  7. The subversion of urine drug testing.

    PubMed

    Berge, Keith H; Bush, Donna M

    2010-08-01

    Since government and private industry have instituted urine drug testing to ensure a drug-free work force, an industry dedicated to subverting the results of those tests has developed. This article describes that industry, the types of products it markets, and efforts to curb the sale of those products.

  8. English Language Teaching Profile: Sweden.

    ERIC Educational Resources Information Center

    British Council, London (England). English-Teaching Information Centre.

    This profile in outline form of the English language teaching situation in Sweden discusses the role of English within Swedish society and within the Swedish educational system. The status of English as the principal foreign language since 1945 for use in business, the media and tourism is pointed out. The system of English instruction in the…

  9. English Language Teaching Profile: Yugoslavia.

    ERIC Educational Resources Information Center

    British Council, London (England). English Language and Literature Div.

    The role of English in Yugoslavia is discussed, with attention directed to (1) education within the education system, (2) English teachers, (3) inservice teacher training, (4) teaching materials, (5) adult education institutes, and (6) British and American support for the teaching of English. Although English is not used as a medium of instruction…

  10. My Hesitation to Speak English

    ERIC Educational Resources Information Center

    Oda, Naruha

    2015-01-01

    Even though English was the author's favorite subject, she was not good at speaking in English, and always tried to avoid it. However, it did not matter because she did not have to speak to demonstrate her English ability. After entering university, her lack of confidence in speaking English became a major issue, and other students face the same…

  11. English Language Teaching Profile: Bangladesh.

    ERIC Educational Resources Information Center

    British Council, London (England). English-Teaching Information Centre.

    This profile of the English language teaching situation in Bangladesh discusses the role of English in the community and within the educational system. The amount of time devoted to English is discussed, as well as the syllabus used, the teaching staff, teacher training, and teaching materials. English instruction outside the educational system is…

  12. English Language Teaching Profile: India.

    ERIC Educational Resources Information Center

    British Council, London (England). English-Teaching Information Centre.

    This profile in outline form examines the English language teaching situation and the role of English in India. The profile considers these issues by region, that is, the eastern, southern and northern regions of the country. For each region, the following topics are covered: the role of English; English within the educational system, including a…

  13. Workplace Literacy: Developing and Implementing an ESL Curriculum for Limited English Proficient Poultry Workers.

    ERIC Educational Resources Information Center

    Merlin, Shirley B.

    The report describes the development and implementation of an English-as-a-Second-Language (ESL) program for limited-English-proficient employees of the poultry industry. The program, undertaken at James Madison University (Virginia), was funded initially in 1991 by the federal government and has continued with funding from two poultry companies.…

  14. Making an Economic Impact: Higher Education and the English Regions. Research Report

    ERIC Educational Resources Information Center

    Kelly, Ursula; McLellan, Donald; McNicoll, Iain

    2010-01-01

    This is the first published study of the impact of the higher education sector on the English regions. This study presents key economic features of UK higher education in the academic year 2007/08 and those aspects of its contribution to the nine English regions that can be readily measured. The sector is analysed as a conventional industry,…

  15. The Third Way: A Call for Breaking the Dependency on the Mainstream English Language Teaching

    ERIC Educational Resources Information Center

    Davari, Hossein; Aghagolzadeh, Ferdows; Golfam, Arsalan; Kambuziya, Aliyeh Kord Zafaranlu

    2014-01-01

    The worldwide spread of English, especially through the tenets and assumptions of the mainstream English language teaching (ELT) has had ideological, socio-cultural and political implications in the field of education. Reviewing these tenets and assumptions, this paper attempts to reveal this growing industry through publicizing the spread of…

  16. Drugs in sport.

    PubMed

    McGrath, J C; Cowan, D A

    2008-06-01

    This themed issue of the British Journal of Pharmacology has been compiled and edited by Ian McGrath, Regius Professor of Physiology at University of Glasgow and David Cowan, Director of the Drug Control Centre at King's College London. It contains 11 articles covering the mechanisms of action of the major groups of drugs used illicitly in sport. The articles, written by experts in how drugs work, set out where drugs can or cannot affect sporting performance, how this relates to their legitimate medicinal use, their other detrimental effects and how they can be detected. Publication coincides with Olympic year, when sport is highlighted in the public mind and much speculation is made concerning the use of drugs. The articles provide a framework of expert, accurate knowledge to inform and facilitate these debates and to help to overcome the ill-informed and dangerous anecdotal information by which sports men and women are persuaded to misuse drugs in the mistaken belief that this will improve their performance without present or future ill effects. A unique article is included by the Spedding brothers, Mike with a long career in drug discovery and Charlie, the 1984 Los Angeles Olympic Marathon Bronze Medallist and still the English National Marathon record holder. From their unique experience, they describe the insidious and unfair way that drug-assisted performance undermines the ethos of sport and endangers the vital place of sport in maintaining the health of the population.

  17. 21 CFR 803.13 - Do I need to submit reports in English?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Do I need to submit reports in English? 803.13 Section 803.13 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.13 Do I need to submit...

  18. English for Business

    ERIC Educational Resources Information Center

    Moulin, Andre

    1974-01-01

    Examines four publications meant for intermediate or even advanced learners of English: first, two handbooks of commercial correspondence, then, two methods designed to develop the four basic language skills. (Author/PMP)

  19. 77 FR 61006 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-05

    ... HUMAN SERVICES Food and Drug Administration Request for Notification From Industry Organizations... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... CONTACT: Caryn Cohen, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate...

  20. Communication Skills for the Cosmetology Industry.

    ERIC Educational Resources Information Center

    Rader, Wendy

    This teaching guide contains materials for 24 2-hour lessons for people with limited English proficiency who are seeking a job in the cosmetology industry or seeking enrollment in cosmetology courses. The course is intended to improve students' abilities to communicate orally with customers in a cosmetology setting and to improve job seeking and…

  1. Clinically relevant drug interactions with anti-Alzheimer's drugs.

    PubMed

    Caraci, Filippo; Sultana, Janet; Drago, Filippo; Spina, Edoardo

    2017-03-03

    The aging world population had led to an increase in the prevalence of Alzheimer's disease (AD). The drugs used to slow down the onset of AD, galantamine, donepezil, rivastigmine and memantine, are generally well-tolerated. However, drug interactions between these drugs and other drugs are an important aspect of patient safety that should be borne in mind, particularly given the high burden of polypharmacy in the elderly. The aim of this review is to provide an updated review of clinically significant drug-drug interactions concerning drugs approved for AD. PubMed was searched for relevant keywords. No time limit was imposed but only articles in English published in peer-reviewed journals were selected. Relevant literature was also identified from the references of identified articles. Further information was obtained from drug summary of product characteristics. The major pharmacokinetic interactions identified concerned fluoxetine, paroxetine and ketoconazole when used with galantamine or donepezil. On the other hand, the major potential pharmacodynamic interactions concerned anti-dementia drugs and general anesthesia agents, anti-cholinergic drugs, conventional antipsychotics and bradycardia-inducing drugs. In clinical practice memantine shows a lower potential for pharmacodynamic drug-drug interactions (DDIs) compared to other drug classes. In conclusion, the concomitant use of anti-dementia drugs with other drugs can have variable clinical effects, making appropriate prescribing of these drugs very challenging. A simple and coherent way of presenting evidence on complex drug interaction information from heterogenous sources to clinicians is needed in order for the voluminous data available to have an impact on clinical practice.

  2. Drug allergies

    MedlinePlus

    Allergic reaction - drug (medication); Drug hypersensitivity; Medication hypersensitivity ... A drug allergy involves an immune response in the body that produces an allergic reaction to a medicine. The ...

  3. Industrial Robots.

    ERIC Educational Resources Information Center

    Reed, Dean; Harden, Thomas K.

    Robots are mechanical devices that can be programmed to perform some task of manipulation or locomotion under automatic control. This paper discusses: (1) early developments of the robotics industry in the United States; (2) the present structure of the industry; (3) noneconomic factors related to the use of robots; (4) labor considerations…

  4. Industrial garnet

    USGS Publications Warehouse

    Olson, D.W.

    2000-01-01

    The state of the global industrial garnet industry in 1999 is discussed. Industrial garnet mined in the U.S., which accounts for approximately one-third of the world's total, is usually a solid-solution of almandine and pyrope. The U.S. is the largest consumer of industrial garnet, using an estimated 47,800 st in 1999 as an abrasive and as a filtration medium in the petroleum industry, filtration plants, aircraft and motor vehicle manufacture, shipbuilding, wood furniture finishing operations, electronic component manufacture, ceramics manufacture, and glass production. Prices for crude concentrates ranged from approximately $50 to $110/st and refined garnet from $50 to $215/st in 1999, depending on type, source, quantity purchased, quality, and application.

  5. Questioning Linguistic Instrumentalism: English, Neoliberalism, and Language Tests in Japan

    ERIC Educational Resources Information Center

    Kubota, Ryuko

    2011-01-01

    Linguistic instrumentalism, which underscores the importance of English skills for work and for achieving individual economic success, has influenced language education policies and proliferated the language teaching and testing industry in Japan. Linguistic instrumentalism is linked to the notion of human capital (i.e., skills deemed necessary…

  6. The Cutting Edge: Workplace English. Section I: Project Handbook.

    ERIC Educational Resources Information Center

    El Paso Community Coll., TX. Literacy Center.

    A model workplace literacy program of El Paso Community College (Texas), in cooperation with Levi Strauss and Company, is described. The partnership designed a three-part, job-specific, video-based curriculum in English as a Second Language (ESL) for garment industry workers, implemented in seven local plants. The 18-month program had these goals:…

  7. Medical English for Finnish Doctors

    PubMed Central

    Collan, Y.; Lock, S. P.; Pyke, D. A.; Whimster, W. F.

    1974-01-01

    Courses in medical editing and medical English are relatively new and infrequent. We have now provided seven of them for Finnish doctors who wished to publish their work in English, to present papers in English to conferences, to work in English-speaking countries—or who wanted to improve their knowledge of the language. Although such courses should be tailored to individual needs, most participants seem to have found them helpful, particularly the sessions spent in the language laboratories. We suggest that courses in medical English might be useful for both medical students and postgraduate doctors outside English-speaking countries. PMID:4821015

  8. Trends in Industry Supervisors' Feedback on Business Communication Internships

    ERIC Educational Resources Information Center

    Sapp, David Alan; Zhang, Qin

    2009-01-01

    The purpose of this empirical study is to explore expectations of industry insiders and identify how student interns are performing in relation to those expectations as defined by 11 performance areas. The results of a survey of 238 industry supervisors were collected over a 5-year period in the departments of English and communication at a…

  9. Translating Word-Play: French-English, English-French.

    ERIC Educational Resources Information Center

    Gordon, W. Terrence

    1986-01-01

    The linguistic complexity of humor is illustrated with examples of word play translated from French to English and English to French. Examples from the writings of James Joyce and Marcel Proust are highlighted. (CB)

  10. Drug Safety

    MedlinePlus

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  11. Chemistry in the Pharmaceutical Industry

    NASA Astrophysics Data System (ADS)

    Poindexter, Graham S.; Pendri, Yadagiri; Snyder, Lawrence B.; Yevich, Joseph P.; Deshpande, Milind

    This chapter will discuss the role of chemistry within the pharmaceutical industry. Although the focus will be upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first world nations such as Japan and those in Europe. The major objective of the pharmaceutical industry is the discovery, development, and marketing of efficacious and safe drugs for the treatment of human disease. Of course drug companies do not exist as altruistic, charitable organizations but like other share-holder owned corporations within our capitalistic society must achieve profits in order to remain viable and competitive. Thus, there exists a conundrum between the dual goals of enhancing the quality and duration of human life and that of increasing stock-holder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships this places upon the elderly and others of limited income.

  12. Industrial College of the Armed Forces Industry Studies 2002: Biotechnology

    DTIC Science & Technology

    2002-01-01

    biology, genetics and genetic engineering, and cell fusion techniques using living organisms or their products to manufacture industrial products including...leavening agent. Yeast also produces alcohol during the production of wine and beer. Bacteria produce lactic acid for making yogurt and acetic acid...of a biotech drug company depends on its ability to translate basic scientific research into drugs that can be manufactured and sold at sufficient

  13. On Differences between General English Teaching and Business English Teaching

    ERIC Educational Resources Information Center

    Zhu, Wenzhong; Liao, Fang

    2008-01-01

    With the accelerating rate of globalization, business exchanges are carried out cross the border, as a result there is a growing demand for talents professional both in English and Business. We can see that at present Business English courses are offered by many language schools in the aim of meeting the need for Business English talent. Many…

  14. African American Evaluations of Black English and Standard American English.

    ERIC Educational Resources Information Center

    White, Michael J.; Vandiver, Beverly J.; Becker, Maria L.; Overstreet, Belinda G.; Temple, Linda E.; Hagan, Kelly L.; Mandelbaum, Emily P.

    1998-01-01

    Studied the perceptions of 55 African American undergraduates about Black English. Students identified as not having a committed Black identity evaluated Black English as lower in status than those students with a committed Black identity. Black English was not perceived as reflecting higher social solidarity. (SLD)

  15. Practices That Promote English Reading for English Learners (Els)

    ERIC Educational Resources Information Center

    Martínez, Rebecca S.; Harris, Bryn; McClain, Maryellen Brunson

    2014-01-01

    Schools are becoming increasingly diversified; however, training and professional development related to working with English language learners (ELs), especially in the area of English reading, is limited. In this article, we identify three "Big Ideas" of effective and collaborative practices that promote English reading achievement for…

  16. Japanese College Students' Attitudes towards Japan English and American English

    ERIC Educational Resources Information Center

    Sasayama, Shoko

    2013-01-01

    This study investigated contemporary Japanese college students' attitudes towards Japan English (JE) and American English (AE) through a verbal guise test (VGT) as well as a questionnaire. Forty-four Japanese college students listened to four Japanese and four North Americans reading a text in English, rated them in terms of solidarity-related…

  17. THE TEACHING OF ENGLISH TO NON-ENGLISH-SPEAKING MIGRANTS.

    ERIC Educational Resources Information Center

    VITO, LAWRENCE

    THIS PROVISIONAL GUIDE FOR TEACHING ENGLISH TO NON-ENGLISH SPEAKING MIGRANTS PRESENTS THE USUAL ENGLISH LINGUISTIC PROBLEMS OF SPANISH-SPEAKING LEARNERS--CONSONANT SOUND PROBLEMS, VOWEL SOUND PROBLEMS, CONSONANT CLUSTER PROBLEMS, LANGUAGE RHYTHM PROBLEMS, AND INTONATION PROBLEMS. AIDS TO SPANISH USAGE AND PRONUNCIATION, INCLUDING VOWEL SOUNDS,…

  18. The English of Business Is the Business of English.

    ERIC Educational Resources Information Center

    Versluis, Edward B.

    Three arguments lead to the conclusion that the English of business is the business of English. First, reluctance to fully appreciate the English of Business stems in part from a serious misunderstanding about the development of written language in the Western tradition. While studying folktales and the origins of myths has made an awareness of…

  19. ENGLISH FOR TODAY. BOOK SIX, LITERATURE IN ENGLISH.

    ERIC Educational Resources Information Center

    SLAGER, WILLIAM R.; AND OTHERS

    THE SIXTH AND LAST VOLUME IN THE "ENGLISH FOR TODAY" SERIES, "LITERATURE IN ENGLISH" PRESENTS A WIDE RANGE OF WELL-KNOWN CONTEMPORARY WRITERS FROM THE ENGLISH-SPEAKING WORLD--ENGLAND, THE UNITED STATES, AUSTRALIA, CANADA, INDIA, IRELAND, AND SCOTLAND. THE SELECTIONS INCLUDE--(I) SHORT STORIES BY SAKI, CALLAGHAN, O'CONNOR, HEMINGWAY, JOYCE,…

  20. World Englishes, English as an International Language and Applied Linguistics

    ERIC Educational Resources Information Center

    Kilickaya, Ferit

    2009-01-01

    The paper discusses World Englishes (WEs) in relation to English as an International Language (EIL) and Applied Linguistics. Taking into account Kachru's interesting but at the same time controversial debate about the status of English in its varieties, which are commonly called WEs and the opposing ideas presented by Quirk, it is aimed to present…

  1. English Language Teaching Profile: Saudi Arabia.

    ERIC Educational Resources Information Center

    British Council, London (England). English Language and Literature Div.

    The role and status of English in Saudi Arabia are examined, with attention directed to: (1) English within the education system; (2) teachers of English; (3) English outside the education system; (4) materials support; (5) British support for the teaching of English; and (6) English syllabi at intermediate, secondary, and higher education levels.…

  2. Drug Themes in Science Fiction. National Institute on Drug Abuse Research Issues 9.

    ERIC Educational Resources Information Center

    Silverberg, Robert

    This booklet is part of a series most of which focus on empirical research findings and major theoretical approaches in the area of drug usage. In this volume, the author has compiled a group of English-language short stories and novels which deal with the use of mind-altering drugs, all written since 1900 and falling within the literary category…

  3. Electronics Industry

    DTIC Science & Technology

    2006-01-01

    companies to begin listing stock options as expenses on financial reports (Chappell, 2005). The industry had used stock options extensively to help... stock options (Chappell, 2005). Industry representatives interviewed by the group argued against the requirement since they predict U.S. companies...may be less inclined now to offer stock options , and subsequently talent may be lost to aggressive foreign competition (Anonymous interviews, 2006

  4. The General English Proficiency Test

    ERIC Educational Resources Information Center

    Shih, Chih-Min

    2008-01-01

    Since 2000, the General English Proficiency Test, a newly developed test of English, has been phased in by the Language Training and Testing Center in Taiwan. It has become the most universally used test of English in Taiwan, a fact that can be evidenced by its aggregate number of registered test takers. This article first describes the…

  5. Brunei English: A Developing Variety

    ERIC Educational Resources Information Center

    O'Hara-Davies, Breda

    2010-01-01

    A considerable amount of time has elapsed since the existence of a distinct variety of English, Brunei English (BNE), was mooted in the early 1990s. A subsequent study conducted by Svalberg in 1998 suggested that BNE was then in its infancy and that its speakers were largely unaware of the differences between it and Standard British English (STE).…

  6. World Englishes and Applied Linguistics.

    ERIC Educational Resources Information Center

    Kachru, Braj B.

    This paper addresses the issue of the relationship between World Englishes (WE) and applied linguistics. The diffusion of English is seen in terms of three concentric circles: the Inner Circle (first-language varieties, e.g., the United States, United Kingdom), the Outer Circle (English-as-a-Second-Language varieties), and the Expanding Circle…

  7. Teachers' Habitus for Teaching English

    ERIC Educational Resources Information Center

    Flynn, Naomi

    2015-01-01

    In this examination of monolingual and multilingual pedagogies I draw on literature that explores the position of English globally and in the curriculum for English. I amplify the discussion with data from a project exploring how teachers responded to the arrival of Polish children in their English classrooms following Poland's entry to the…

  8. Chinese English Learners' Strategic Competence

    ERIC Educational Resources Information Center

    Wang, Dianjian; Lai, Hongling; Leslie, Michael

    2015-01-01

    The present study aims to investigate Chinese English learners' ability to use communication strategies (CSs). The subjects are put in a relatively real English referential communication setting and the analyses of the research data show that Chinese English learners, when encountering problems in foreign language (FL) communication, are…

  9. English Teachers' Journal (Israel), 1991.

    ERIC Educational Resources Information Center

    English Teachers' Journal (Israel), 1991

    1991-01-01

    This document consists of the two issues of "English Teachers' Journal (Israel)" issued during 1991. Contents include: "Introduction for English Teachers"; "Announcements for Bagrut Teachers and Examiners"; "News from E.T.A.I. (English Teachers' Association of Israel)" (Ephraim Weintroub); "Learning…

  10. English Teaching Profile: Hong Kong.

    ERIC Educational Resources Information Center

    British Council, London (England). English Language and Literature Div.

    A review of the status of English language instruction in Hong Kong begins with an overview of the role of English in the society in general, and outlines the status of English use and instruction in the educational system at all levels (elementary, secondary, higher, vocational, adult, and teacher), the characteristics and training of English…

  11. English Language Teaching Profile: Uruguay.

    ERIC Educational Resources Information Center

    British Council, London (England). English-Teaching Information Centre.

    This profile in outline form of the English language teaching situation in Uruguay discusses the role of English within Uruguayan society and within the educational system. Though English is quite widely used for reading scientific, technical and medical publications, and while it is considered important culturally in higher professions, it is not…

  12. Symposium: What Is College English?

    ERIC Educational Resources Information Center

    Bloom, Lynn Z.; White, Edward M.; Enoch, Jessica; Hawk, Byron

    2013-01-01

    This symposium explores the role(s) College English has (or has not) had in the scholarly work of four scholars. Lynn Bloom explores the many ways College English influenced her work and the work of others throughout their scholarly lives. Edward M. White examines four articles he has published in College English and draws connections between…

  13. Some "English" Words in French.

    ERIC Educational Resources Information Center

    Thogmartin, Clyde

    1984-01-01

    Examines "pseudoborrowing" of some English words into the French vocabulary. Considered the prestige language of Western Europe, English is viewed as a social hallmark of higher education; thus, even a modest knowledge and use of English reinforces this attitude. However, also suggests a modification of this concept, noting a reciprocal prestige…

  14. English Teachers' Journal (Israel), 1992.

    ERIC Educational Resources Information Center

    English Teachers' Journal (Israel), 1992

    1992-01-01

    This document consists of the two issues of "English Teachers' Journal (Israel)" issued during 1992. Articles include: "Information for English Teachers"; "Announcements for Bagrut Teachers and Examiners"; "News from Educational Television" (Lily Vered and Others); "News from E.T.A.I. (English Teachers'…

  15. Fundamentals of English Language Teaching.

    ERIC Educational Resources Information Center

    Kitao, S. Kathleen; Kitao, Kenji

    English is not the most widely spoken language in the world, but it is the most widely used by non-native speakers, making the teaching of English as a Second Language a very important endeavor. This book provides an overview of English language teaching, giving the reader a general background on the issues related to language…

  16. The English Language Growth Project

    ERIC Educational Resources Information Center

    Rochecouste, Judith; Oliver, Rhonda; Mulligan, Denise; Davies, Martin

    2011-01-01

    The English Language Growth (ELG) Project was conducted in five Australian universities in 2008-09 to address the on-going English language development of international students from non-English speaking backgrounds. Using an online survey inviting both qualitative and quantitative responses, 798 international students provided a rich source of…

  17. Prosodic Features of Hawaiian English

    ERIC Educational Resources Information Center

    Vanderslice, Ralph; Pierson, Laura Shun

    1967-01-01

    This paper describes a "neglected" aspect of Hawaiian ("Pidgin") English--the suprasegmental or prosodic features. Illustrated by contrastive samples of Hawaiian American English (HAE) and General American English (GAE), the salient prosodic features are presented as follows--(1) syllable-timed rhythm, modified by emphatic…

  18. Effective Instruction for English Learners

    ERIC Educational Resources Information Center

    Calderon, Margarita; Slavin, Robert; Sanchez, Marta

    2011-01-01

    The fastest-growing student population in U.S. schools today is children of immigrants, half of whom do not speak English fluently and are thus labeled English learners. Although the federal government requires school districts to provide services to English learners, it offers states no policies to follow in identifying, assessing, placing, or…

  19. Project English Summaries, March 1970.

    ERIC Educational Resources Information Center

    Haughey, Charles F.; And Others

    Information concerning Project English, which is being carried out at 14 universities and 1 State Department of Education through the support of the Office of Education, is provided in summary format. Project English is concerned with the development of English curriculum for Grades K through 12 and with the development of curriculum for…

  20. English in the Jordanian Context

    ERIC Educational Resources Information Center

    Hamdan, Jihad M.; Hatab, Wafa A. Abu

    2009-01-01

    The paper explores the status of English in Jordan as reflected in newspaper job advertisements (ads) published in 1985, 1995 and 2005, and English language documents in the educational domain. The study shows a steady increase in the percentage of English ads paralleled with a steady decrease in the percentage of Arabic ads. Further, it reports a…

  1. Unconventional Internships for English Majors.

    ERIC Educational Resources Information Center

    Otto, Don H.

    After five years of research, the English department at St. Cloud (Minnesota) State University created an internship program for English majors. The philosophy behind the program is that the typical experience of the English major in college is excellent preparation for what the college graduate will be doing in most careers in business,…

  2. Teaching English to American Indians.

    ERIC Educational Resources Information Center

    Reyhner, Jon

    Many practices in Bureau of Indian Affairs (BIA) schools were negative, but this paper emphasizes the positive efforts that were made throughout their history, especially in regard to teaching English. The Carlisle Indian School, which opened in 1879, encouraged the use of English through an English language student newspaper and frequently…

  3. The Benefits of English Immersion.

    ERIC Educational Resources Information Center

    Porter, Rosalie Pedalino

    2000-01-01

    In 1998, California voters approved Initiative 227, requiring that all limited-English children be provided an English-immersion program for 1 year or longer as needed. Hispanic parents are leaders in the movement. Dire predictions that bilingual children in English-language classrooms would fall behind have not materialized. (Contains 18…

  4. The Ecology of Global English

    ERIC Educational Resources Information Center

    Canagarajah, A. Suresh

    2007-01-01

    Global English is under contestation. Although some consider lingua franca English (LFE) as a neutral medium or code that does not belong to any specific culture or nationality, others see the deceptive nature of this linguistic globalization. Along with Spring (2007/this issue), they see global English as embodying partisan interests and values.…

  5. Intercultural Processes in Accented English

    ERIC Educational Resources Information Center

    Rivers, Damian J.

    2011-01-01

    This study assessed the attitudinal responses of 48 Japanese university students towards 10 accented English speech samples across nine evaluative criteria. Of the 10 samples, one was a Japanese-English speech sample (the intracultural familiar), seven were non-native-English samples originating from a variety of Asian countries (intercultural…

  6. Drugs, drugs--who has the drugs?

    PubMed

    Blair, James

    2012-01-01

    Drug diversion, although on the increase, is not the only problem involving drugs that hospital security officials should be concerned with. Growing drug shortages, offshore production, counterfeiting, and weaknesses in the drug supply chain in case of a world-wide pandemic, are even greater causes for concern, the author claims.

  7. 77 FR 71804 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-04

    ... HUMAN SERVICES Food and Drug Administration Request for Notification From Industry Organizations... Nominations for Nonvoting Industry Representatives on the Device Good Manufacturing Practice Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  8. 76 FR 59142 - Guidance for Industry on Reproductive and Developmental Toxicities-Integrating Study Results To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Reproductive and Developmental... a guidance for industry entitled ``Reproductive and Developmental Toxicities--Integrating Study... developmental or reproductive risks associated with drug or biological product exposure when a...

  9. 76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements: New...: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and... notice entitled ``Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient...

  10. Reconsidering English Grammar Teaching for Improving Non-English Majors' English Writing Ability

    ERIC Educational Resources Information Center

    Shen, Yuru

    2012-01-01

    With the globalization of world economy, English learners' writing ability has been attached less and less importance. As a result, many college students in China, especially the non-English majors, cannot express themselves effectively in written English. They make various kinds of mistakes, mostly grammar mistakes, such as writing sentence…

  11. English Leadership Quarterly. 1991.

    ERIC Educational Resources Information Center

    Strickland, James, Ed.

    1991-01-01

    These four issues of the English Leadership Quarterly represent the quarterly for 1991. Articles in number 1 deal with whole language and include: "CEL: Shorter and Better" (Myles D. Eley); "Toward a New Philosophy of Language Learning" (Kathleen Strickland); "Whole Language: Implications for Secondary Classrooms"…

  12. Behavioral Objectives for English

    ERIC Educational Resources Information Center

    Zoellner, Robert

    1972-01-01

    A review-critique of On Writing Behavioral Objectives for English, by John Maxwell and Anthony Lovat, in which behavioral objectives theory is dominated by a stimulus-response rather than a stimulus-response-reinforcement psychology. The reviewer questions whether behavioral objectives can be applied accurately and without distortion of meanings,…

  13. Varieties of English.

    ERIC Educational Resources Information Center

    Brook, G. L.

    The English language is not a monolithic entity but an amalgam of many different varieties that can be associated respectively with groups of speakers, with individuals, and with the occasion. Among such varieties are slang, regional and class dialects, the language of children, and the language used by public speakers, journalists, lawyers,…

  14. English 3135: Visual Rhetoric

    ERIC Educational Resources Information Center

    Gatta, Oriana

    2013-01-01

    As an advanced rhetoric and composition doctoral student, I taught Engl 3135: Visual Rhetoric, a three-credit upper-level course offered by the Department of English at Georgia State University. Mary E. Hocks originally designed this course in 2000 to, in her words, "introduce visual information design theories and practices for writers [and]…

  15. Fostering English Learners' Confidence

    ERIC Educational Resources Information Center

    Bondie, Rhonda; Gaughran, Laurie; Zusho, Akane

    2014-01-01

    A teacher is doing something right when his high school students--kids with limited English, no less--form groups and begin discussing a lesson on quadratic equations at the start of class, without any teacher direction. Bondie, Gaughran, and Zusho describe "discussion routines" that teachers at International Community High School in the…

  16. English Leadership Quarterly, 1993.

    ERIC Educational Resources Information Center

    Strickland, James, Ed.

    1993-01-01

    These four issues of the English Leadership Quarterly represent those published during 1993. Articles in number 1 deal with parent involvement and participation, and include: "Opening the Doors to Open House" (Jolene A. Borgese); "Parent/Teacher Conferences: Avoiding the Collision Course" (Robert Perrin); "Expanding Human…

  17. English Leadership Quarterly, 1994.

    ERIC Educational Resources Information Center

    Strickland, James, Ed.; Kiernan, Henry, Ed.

    1994-01-01

    These 4 issues of the English Leadership Quarterly comprise volume 16, published during 1994. Articles in number 1 deal with practical advice, and include: "The Law of Privacy and the Writing Teacher" (Ben T. Allen); Beware of Teachers Who Laminate Their Lesson Plans and Other Useful Suggestions about Teaching" (Robert Perrin);…

  18. English Leadership Quarterly, 1992.

    ERIC Educational Resources Information Center

    Strickland, James, Ed.

    1992-01-01

    These four issues of the English Leadership Quarterly represent those published during 1992. Articles in number 1 deal with testing assessing, and measuring student performance, and include: "Real Evaluation: Portfolios as an Effective Alternative to Standardized Testing" (Kate Kiefer); "No More Objective Tests, Ever" (Carol…

  19. English Education and Aging.

    ERIC Educational Resources Information Center

    Gillis, Candida

    1983-01-01

    Suggests that English teachers are in an excellent position to help students learn about the aged and aging because they know literature that treats the joys and pains of later life and they understand how language shapes and reflects cultural attitudes. Proposes objectives and presents samples of activities to be used in an aging unit. (MM)

  20. The Paradox of English

    ERIC Educational Resources Information Center

    O'Hara-Davies, Breda

    2010-01-01

    This paper summarises the results of a qualitative study which focused on 60 Malay students aged 17-19 years in Brunei Darussalam. It explored the interplay of factors that colour the participants' attitude to the English language and its role in their education as well as in their lives. Brunei's status as a former British protectorate was taken…

  1. Is English Changing?

    ERIC Educational Resources Information Center

    Birner, Betty, Ed.

    This brochure discusses, in lay terms, how languages change and how English in particular has gone through much alteration over the ages. It explains that languages change because: the needs of its speakers change; individual experience differs, and, therefore, the uses of language differ; new words are brought in from other languages or created…

  2. English II. Revised.

    ERIC Educational Resources Information Center

    Spann, Margaret; And Others

    This manual is intended to enable academically disadvantaged and disabled youth to acquire basic communications and English skills while also acquiring a salable vocational skill. The following topics are covered in the individual units: related vocational information (abbreviations); related vocational skills (job search, job application forms,…

  3. HAIKU IN ENGLISH.

    ERIC Educational Resources Information Center

    HENDERSON, HAROLD G.

    CONVENTIONS FOR CLASSICAL JAPANESE HAIKU USUALLY INCLUDE--17 JAPANESE SYLLABLES IN A 5-7-5 LINE PATTERN, AND SOME SPECIFIC REFERENCE TO AN ASPECT OF NATURE AND TO A PARTICULAR EVENT, PRESENTED AS IF IT WERE HAPPENING IN THE IMMEDIATE PRESENT TO ALLOW THE READER TO EXPERIENCE THE POET'S EMOTION. HAIKU IN ENGLISH, A FORM OF POETRY WHICH HAS BECOME…

  4. English-Dari Dictionary.

    ERIC Educational Resources Information Center

    Peace Corps, Washington, DC.

    This 7,000-word dictionary is designed for English speakers learning Dari. The dictionary consists of two parts, the first a reference to find words easily translatable from one language to the other, the second a list of idioms and short phrases commonly used in everyday conversation, yet not readily translatable. Many of these entries have no…

  5. Elective English Curriculum.

    ERIC Educational Resources Information Center

    Palm Springs High School, CA.

    This document contains course descriptions of 37 elective English courses divided into five levels for sophomore, junior, and senior high school students--the higher levels having more difficult reading and more demanding work, and requiring better writing skills and more independent study habits. An explanation of the composition, grammar,…

  6. The Subject Is English

    ERIC Educational Resources Information Center

    Scott, Melanie

    2007-01-01

    Students will have to use language all their lives, whether they are signing off on stock investments, guiding airplanes to land, or writing the next great novel. Language is the stuff of communication, and English happens to be the most commonly used language in the world. However, Canadian schools do not adequately prepare young people to use…

  7. English Leadership Quarterly, 1995.

    ERIC Educational Resources Information Center

    Kiernan, Henry, Ed.

    1995-01-01

    These 4 issues of the English Leadership Quarterly comprise volume 17, published during 1995. Articles in number 1 deal with multicultural and multiethnic literature, and are, as follows: "Guidelines for Selecting European Ethnic Literature for Interdisciplinary Courses" (Sandra Stotsky); "Striving for Kinship within Diverse Communities" (Peter…

  8. EIGHTH GRADE ENGLISH CURRICULUM.

    ERIC Educational Resources Information Center

    University City School District, MO.

    A CURRICULUM GUIDE FOR TEACHING EIGHTH-GRADE ENGLISH WAS DEVELOPED IN 1965 AT UNIVERSITY CITY, MISSOURI. FOUR UNITS ARE PRESENTED IN DETAILED OUTLINE FORM--"PAST THROUGH PROLOGUE,""GROWING UP,""WHAT IS HUMOR," AND "HEROES, REAL AND UNREAL." THREE OTHER UNITS ARE SUGGESTED BUT NOT OUTLINED--"VALUE AND…

  9. English: Progress and Transition.

    ERIC Educational Resources Information Center

    Burton, Dwight L.

    The assessments of the work of the curriculum study centers and the insights of the Dartmouth Seminar in the past decade have given rise to six major directions in the teaching of English: (1) increased relevance and vitality in literature study through attention to student response to literature and elimination of censorship and moral bias, (2)…

  10. Reaching English Language Learners

    ERIC Educational Resources Information Center

    Keenan, Suzanne

    2004-01-01

    In the authors' science classroom, students who are English Language Learners (ELL) seem to struggle less than they do with other content areas. She believes the "handson" nature of science motivates and encourages students to interact with others. This interaction spurs conversation among the students involved in the activity. If a child is…

  11. The English Verb System.

    ERIC Educational Resources Information Center

    Gorayska, Barbara

    1978-01-01

    Techniques of teaching the English finite verb to speakers of other languages must account for meaning that is signalled by the structure alone and meaning derived from the context. Accordingly, this study attempts to distinguish the semantic components of the finite verb structure. The structure is viewed as being always composed of the following…

  12. English for American Indians.

    ERIC Educational Resources Information Center

    Slager, William R., Ed.; Madsen, Betty M., Ed.

    The present issue of "English for American Indians" follows the format and approach of the Spring 1970 issue. (See ED 040 396.) In the lead article, Evelyn Hatch surveys some of the research in first language acquisition and points out its implications for second language teaching. Her main thesis is that with the best of intentions,…

  13. Help through Learning English.

    ERIC Educational Resources Information Center

    Mitchell, Elizabeth

    Teaching English as a second language is the purpose of this curriculum guide developed for adult basic literacy classes within the Home Education Livelihood Program in New Mexico. The guide consists of 16 teaching units composed of conversations and exercises with teaching notes. Emphasis is on memorization through oral and written drills. A…

  14. English Only JAMAS.

    ERIC Educational Resources Information Center

    Cartagena, Juan

    1989-01-01

    Puerto Ricans have been largely ignored in the current debate over English as a national language. Once the rhetoric of language restrictionists is discarded, the real issue becomes that of the political empowerment of Puerto Ricans. The history of language policy in relation to Puerto Ricans is also reviewed. (SLD)

  15. English-Cinyanja Dictionary.

    ERIC Educational Resources Information Center

    Zambesi Mission, Mitsidi (Malawi).

    This English-Chinyanja (Cinyanja) dictionary was prepared and published by the Zambesi Mission for use in Africa. Compilers of this volume were aided by Africans of Southern Angoniland and a Yao tribesman from the Blantyre district knowledgeable in Chinyanja. Spelling rules used are those of the United Translation Board, which has adopted…

  16. Morphology and English Spelling.

    ERIC Educational Resources Information Center

    Russell, Paula

    Although approximately one-half of the English lexicon can be spelled according to phoneme-grapheme correspondences, many words in the remaining half of the lexicon can also be spelled systematically on the basis of their morphemic properties rather than on the bases of their pronunciations. This paper discusses the bases for assuming that English…

  17. Regional Norms for English.

    ERIC Educational Resources Information Center

    Kachru, Braj B.

    The debate continues about regional norms for English usage around the world, although the discussion has become more realistic and less didactic. Educated non-native varieties are increasingly accepted, distinctions are being made between national and international language uses, and localized varieties are no longer considered as necessarily…

  18. COMIT English Module.

    ERIC Educational Resources Information Center

    Beam, Paul

    This COMIT English module used most of the interrelated devices of sound, sonic pen, keyboard, slide, and terminal display in a lesson which, depending on the student's interest and ability, might last from four to ten hours and formed an integral part of a second year course in critical analysis. Four contexts were included in the subject of…

  19. English in Colombia.

    ERIC Educational Resources Information Center

    Quintanilla, Victor

    English language education in Colombia has been improved because the teachers have organized professional associations and have received assistance and support from the Colombian and United States governments to improve teaching methods, teacher preparation, and teaching materials. With the help of the University of California at Los Angeles, the…

  20. Situational Variation in English.

    ERIC Educational Resources Information Center

    Littlewood, William T.

    1981-01-01

    Presents data which shows, in a systematic and objective way, how the same speaker can express the same meaning in a variety of ways depending upon the social situation. Such data offer the teacher of English a basis for discussing some of the linguistic features involved in this variation. (Author/PJM)

  1. "Right" in Singapore English

    ERIC Educational Resources Information Center

    Tan, Angela

    2010-01-01

    Singapore English has been, and still is, an enigma for many scholars and researchers. In recent years, much attention has been given to the analysis of its particles. However, rather than focusing on the analysis of one particle or several particles and how they operate at the level of the sentence, this paper looks at a particular phenomenon in…

  2. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2013-01-01

    Estimated 2012 world production of natural and synthetic industrial diamond was about 4.45 billion carats. During 2012, natural industrial diamonds were produced in at least 20 countries, and synthetic industrial diamond was produced in at least 12 countries. About 99 percent of the combined natural and synthetic global output was produced in Belarus, China, Ireland, Japan, Russia, South Africa and the United States. During 2012, China was the world’s leading producer of synthetic industrial diamond followed by the United States and Russia. In 2012, the two U.S. synthetic producers, one in Pennsylvania and the other in Ohio, had an estimated output of 103 million carats, valued at about $70.6 million. This was an estimated 43.7 million carats of synthetic diamond bort, grit, and dust and powder with a value of $14.5 million combined with an estimated 59.7 million carats of synthetic diamond stone with a value of $56.1 million. Also in 2012, nine U.S. firms manufactured polycrystalline diamond (PCD) from synthetic diamond grit and powder. The United States government does not collect or maintain data for either domestic PCD producers or domestic chemical vapor deposition (CVD) diamond producers for quantity or value of annual production. Current trade and consumption quantity data are not available for PCD or for CVD diamond. For these reasons, PCD and CVD diamond are not included in the industrial diamond quantitative data reported here.

  3. 21 CFR 178.3520 - Industrial starch-modified.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Industrial starch-modified. 178.3520 Section 178... SANITIZERS Certain Adjuvants and Production Aids § 178.3520 Industrial starch-modified. Industrial starch... provisions of this section. (a) Industrial starch-modified is identified as follows: (1) A food...

  4. 21 CFR 178.3520 - Industrial starch-modified.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Industrial starch-modified. 178.3520 Section 178... SANITIZERS Certain Adjuvants and Production Aids § 178.3520 Industrial starch-modified. Industrial starch... provisions of this section. (a) Industrial starch-modified is identified as follows: (1) A food...

  5. 21 CFR 178.3520 - Industrial starch-modified.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Industrial starch-modified. 178.3520 Section 178... § 178.3520 Industrial starch-modified. Industrial starch-modified may be safely used as a component of..., transporting, or holding food, subject to the provisions of this section. (a) Industrial starch-modified...

  6. 21 CFR 178.3520 - Industrial starch-modified.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Industrial starch-modified. 178.3520 Section 178... SANITIZERS Certain Adjuvants and Production Aids § 178.3520 Industrial starch-modified. Industrial starch... provisions of this section. (a) Industrial starch-modified is identified as follows: (1) A food...

  7. 21 CFR 178.3520 - Industrial starch-modified.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Industrial starch-modified. 178.3520 Section 178... SANITIZERS Certain Adjuvants and Production Aids § 178.3520 Industrial starch-modified. Industrial starch... provisions of this section. (a) Industrial starch-modified is identified as follows: (1) A food...

  8. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2007-01-01

    World production of natural and synthetic industrial diamond was about 648 million carats in 2006, with 79 percent of the production coming from Ireland, Japan, Russia, South Africa, and the U.S. U.S. consumption was was an estimated 602 million carats, imports were over 391 million carats, and exports were about 83 million carats. About 87 percent of the industrial diamonds market uses synthetic diamonds, which are expected to become less expensive as technology improves and competition from low-cost producers increases.

  9. Industrial garnet

    USGS Publications Warehouse

    Olson, D.W.

    2006-01-01

    In 2005, US production of crude garnet concentrate for industrial use was 28.4 kt valued at $3.05 million. Refined garnet material sold or used was 30.4 kt valued at $10 million. For the year, the US was one of the world's leading consumers of industrial garnet. Domestic values for crude concentrates for different applications ranged from about $53 to $120/t. In the short term, excess production capacity, combined with suppliers that vary in quality, grain size and mineral type, will keep prices down.

  10. Novels and Nonfiction Annotated Listing for English 10, English 13, English 20, English 23, English 30, English 33. Senior High English Language Arts.

    ERIC Educational Resources Information Center

    Alberta Dept. of Education, Edmonton. Curriculum Standards Branch.

    This annotated listing of fiction and nonfiction works suitable for use in Senior High English courses was written and developed by teachers, in Alberta, Canada. It contains 83 new titles and 44 titles carried over from the 1983 list. A specific edition of each of the novel and nonfiction titles in the list has been authorized because of such…

  11. Drug Resistance

    MedlinePlus

    HIV Treatment Drug Resistance (Last updated 3/2/2017; last reviewed 3/2/2017) Key Points As HIV multiplies in the ... the risk of drug resistance. What is HIV drug resistance? Once a person becomes infected with HIV, ...

  12. Fermentation Industry.

    ERIC Educational Resources Information Center

    Grady, C. P. L., Jr.; Grady, J. K.

    1978-01-01

    Presents a literature review of wastes from the fermentation industry, covering publications of 1976-77. This review focuses on: (1) alcoholic beverage production; (2) pharmaceuticals and biochemicals production; and (3) biomass production. A list of 62 references is also presented. (HM)

  13. Industrial Microorganisms.

    ERIC Educational Resources Information Center

    Phaff, Herman J.

    1981-01-01

    Describes industrially important yeasts, molds, bacteria, and actinomycetes. Discussed in detail are microbial products, such as primary metabolites, secondary metabolites, enzymes, and capsular polysaccharides. Traces the historical background of human cell culture, mentioning recombinant DNA research and hybridization of normal mammalian cells…

  14. Industrial garnet

    USGS Publications Warehouse

    Olson, D.W.

    2010-01-01

    In 2009, U.S. production of crude garnet concentrate for industrial use was estimated to be 56.5 kt (62,300 st), valued at about $8.85 million. This was a 10-percent decrease in quantity compared with 2008 production. Refined garnet material sold or used was 28 kt (31,000 st) valued at $7.96 million.

  15. Fermentation industry

    SciTech Connect

    Chiesa, S.C.; Manning, J.F. Jr.

    1983-06-01

    A literature review of the fermenation industry's wastes is presented. In addition to studies on the characterization, treatment, and disposal of wastes in alcohol fuel production, studies concerning wastes from breweries, wineries, yeast manufacture, pharmaceutical production, and distilleries are reviewed. (JMT)

  16. Industrial garnet

    USGS Publications Warehouse

    Olson, D.W.

    2011-01-01

    Garnet has been used as a gemstone since the Bronze Age. However, garnet's angular fractures, relatively high hardness and specific gravity, chemical inertness and nontoxicity make it ideal for many industrial applications. It is also free of crystalline silica and can be recycled.

  17. Industrial garnet

    USGS Publications Warehouse

    Olson, D.W.

    2013-01-01

    Garnet has been used as a gemstone since the Bronze Age. However, garnet’s angular fractures, relatively high hardness and specific gravity, chemical inertness and nontoxicity make it ideal for many industrial applications. It is also free of crystalline silica and can be recycled.

  18. Industrial garnet

    USGS Publications Warehouse

    Olson, D.W.

    2012-01-01

    Garnet has been used as a gemstone since the Bronze Age. However, garnet's angular fractures, relatively high hardness and specific gravity, chemical inertness, and nontoxicity make it ideal for many industrial applications. It is also free of crystalline silica and can be recycled.

  19. Industrial Orientation.

    ERIC Educational Resources Information Center

    Rasor, Leslie; Brooks, Valerie

    These eight modules for an industrial orientation class were developed by a project to design an interdisciplinary program of basic skills training for disadvantaged students in a Construction Technology Program (see Note). The Drafting module overviews drafting career opportunities, job markets, salaries, educational requirements, and basic…

  20. Discontinued drugs in 2012: cardiovascular drugs.

    PubMed

    Zhao, Hong-Ping; Jiang, Hong-Min; Xiang, Bing-Ren

    2013-11-01

    The continued high rate of cardiovascular morbidity and mortality has attracted wide concern and great attention of pharmaceutical industry. In order to reduce the attrition of cardiovascular drug R&D, it might be helpful recapitulating previous failures and identifying the potential factors to success. This perspective mainly analyses the 30 cardiovascular drugs dropped from clinical development in 2012. Reasons causing the termination of the cardiovascular drugs in the past 5 years are also tabulated and analysed. The analysis shows that the attrition is highest in Phase II trials and financial and strategic factors and lack of clinical efficacy are the principal reasons for these disappointments. To solve the four problems (The 'better than the Beatles' problem, the 'cautious regulator' problem, the 'throw money at it' tendency and the 'basic researchbrute force' bias) is recommended as the main measure to increase the number and quality of approvable products.