Investigation of the interfacial reaction between metal and fluorine-contained polyimides

NASA Astrophysics Data System (ADS)

Yang, Ching-Yu; Chen, J. S.; Hsu, S. L. C.

2005-07-01

In this work, thin metal films (Cr and Ta) were deposited on fluorine-contained polyimides, 6FDA-BisAAF, and 6FDA-PPD. The chemical states of the metal/polyimide samples were characterized by using x-ray photoelectron spectroscopy (XPS). XPS analysis reveals that metal-C, C-O, and metal-O bondings are present in metallized 6FDA-BisAAF and 6FDA-PPD. C-F bonds are observed in bare 6FDA-BisAAF and 6FDA-PPD however, they are not seen in the metallized samples. Disappearance of the C-F bonding is attributed to the disruption of CF3 side groups from the main chains of 6FDA-BisAAF and 6FDA-PPD when the chains are exposed to the plasma during the metal deposition. Nevertheless, the disruption of CF3 side groups also creates sites for the formation of metal-C or C-O bondings, which provide a positive adhesion strength at the metal/polyimide interface, as revealed by the tape test.

75 FR 47820 - Generic Drug User Fee; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381... fee program. The number of human generic drug applications awaiting FDA action and the median review... needed for presentations, FDA reserves the right to terminate the meeting early. If you need special...

America, you are digging your grave with your spoon--should the FDA tell you that on food labels?

PubMed

Card, Melissa M

2013-01-01

R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products.

Educating Brazilian workers about AIDS.

PubMed

1991-12-01

This article contains a the script for a slide-tape presentation entitled Working Against AIDS, a presentation developed by the Brazil Family Planning Association (BEMFAM) which is designed to debunk common misconceptions about the disease. This audio-visual, which targets Brazilian workers, can be used during talks, seminars, and meetings. A discussion of the issues involved usually follows the presentation of Working Against AIDS. The presentation contains 30 illustrated slides (these are included in the article). The presentation begins by explaining that much of the information concerning AIDS is prejudicial and misleading. The next few slides point out some of the common misconceptions about AIDS, such as claims denying the existence of the disease, or suggestions that only homosexuals and prostitutes are at risk. The presentation then goes on to explain the ways in which the virus can and cannot be transmitted. Then it discusses how the virus destroys the body's natural defenses and explains the ensuing symptoms. Slides 14 and 15 point out that no cure yet exists for AIDS, making prevention essential. Slides 16-23 explain what actions are considered to be high risk and which ones do not entail risk. Noting that AIDS can be prevented, slide 24 says that the disease should not present an obstacle to spontaneous manifestations of human relations. The next slide explains that condoms should always be used when having sex with someone who could be infected with AIDS. Finally slides 26-30 demonstrate the proper way to use and dispose of a condom.

Frictional sliding inclusions

NASA Astrophysics Data System (ADS)

Huang, Jin H.; Furuhashi, R.; Mura, T.

1993-02-01

S OLUTIONS ARE presented in closed form by using an averaging method for inclusions sliding along an interface due to uniform eigenstrains precribed in the inclusions. The associated stress fields are also analytically determined. A parameter s is introduced to indicate the relative magnitude of sliding compared with the extreme cases of perfect bonding and perfect sliding. When the parameter s becomes zero, the present solution coincides with Eshelby's solution which is the perfectly bonded case. In contrast, when the parameter s is unity, the solution agrees with Volterra's solution (M URA and F URUHASHI, 1984, J. appl. Mech.51, 308] for the perfect sliding case. Because of non-uniform elastic fields caused by sliding along the interface, the well-known Eshelby tensor is modified for the sliding inclusions. Moreover, based on the Mori-Tanaka theory (M ORI and T ANAKA, 1973, Acta Metall.21, 571), an overall stress-strain relation is established to characterize the sliding effect on the overall elastic moduli.

Sliding mode controller with modified sliding function for DC-DC Buck Converter.

PubMed

Naik, B B; Mehta, A J

2017-09-01

This article presents design of Sliding Mode Controller with proportional integral type sliding function for DC-DC Buck Converter for the controlled power supply. The converter with conventional sliding mode controller results in a steady state error in load voltage. The proposed modified sliding function improves the steady state and dynamic performance of the Convertor and facilitates better choices of controller tuning parameters. The conditions for existence of sliding modes for proposed control scheme are derived. The stability of the closed loop system with proposed sliding mode control is proved and improvement in steady state performance is exemplified. The idea of adaptive tuning for the proposed controller to compensate load variations is outlined. The comparative study of conventional and proposed control strategy is presented. The efficacy of the proposed strategy is endowed by the simulation and experimental results. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

Characterization of Instructor and Student Use of Ubiquitous Presenter, a Presentation System Enabling Spontaneity and Digital Archiving

NASA Astrophysics Data System (ADS)

Price, Edward; Malani, Roshni; Simon, Beth

2007-01-01

Ubiquitous Presenter (UP) is a digital presentation system that allows an instructor with a Tablet PC to spontaneously modify prepared slides, while automatically archiving the inked slides on the web. For two introductory physics classes, we examine the types of slides instructors prepare and the ways in which they add ink to the slides. Modes of usage include: using ink to explicitly link multiple representations; making prepared figures dynamic by animating them with ink; and preparing slides with sparse text or figures, then adding extensive annotations during class. In addition, through an analysis of surveys and of web server logs, we examine student reaction to the system, as well as how often and in what ways students' utilize archived material. In general, students find the system valuable and frequently review the presentations online.

OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.

PubMed

Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

2016-01-01

Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs.

Initiation of forward gait with lateral occurrence of emotional stimuli: general findings and relevance for pedestrians crossing roads.

PubMed

Caffier, D; Gillet, C; Heurley, L P; Bourrelly, A; Barbier, F; Naveteur, J

2017-03-01

With reference to theoretical models regarding links between emotions and actions, the present study examined whether the lateral occurrence of an emotional stimulus influences spatial and temporal parameters of gait initiation in 18 younger and 18 older healthy adults. In order to simulate road-crossing hazard for pedestrians, slides of approaching cars were used and they were presented in counterbalanced order with threatening slides from the International Affective Picture System (IAPS) and control slides of safe walking areas. Each slide was presented on the left side of the participant once the first step was initiated. The results evidenced medio-lateral shifts to the left for the first step (right foot) and to the right for the second step (left foot). These shifts were both modulated by the slide contents in such a way that the resulting distance between the screen and the foot (right or left) was larger with the IAPS and traffic slides than with the control slides. The slides did not affect the base of support, step length, step velocity and time of double support. Advancing age influenced the subjective impact of the slides and gait characteristics, but did not modulate medio-lateral shifts. The data extend evidence of fast, emotional modulation of stepping, with theoretical and applied consequences.

NASA SMD E/PO Community Addresses the needs of the Higher Ed Community: Introducing Slide sets for the Introductory Earth and Space Science Instructor

NASA Astrophysics Data System (ADS)

Buxner, S.; Meinke, B. K.; Brain, D.; Schneider, N. M.; Schultz, G. R.; Smith, D. A.; Grier, J.; Shipp, S. S.

2014-12-01

The NASA Science Mission Directorate (SMD) Science Education and Public Outreach (E/PO) community and Forums work together to bring the cutting-edge discoveries of NASA Astrophysics and Planetary Science missions to the introductory astronomy college classroom. These mission- and grant-based E/PO programs are uniquely poised to foster collaboration between scientists with content expertise and educators with pedagogy expertise. We present two new opportunities for college instructors to bring the latest NASA discoveries in Space Science into their classrooms. The NASA Science Mission Directorate (SMD) Astrophysics Education and Public Outreach Forum is coordinating the development of a pilot series of slide sets to help Astronomy 101 instructors incorporate new discoveries in their classrooms. The "Astro 101 slide sets" are presentations 5-7 slides in length on a new development or discovery from a NASA Astrophysics mission relevant to topics in introductory astronomy courses. We intend for these slide sets to help Astronomy 101 instructors include new developments (discoveries not yet in their textbooks) into the broader context of the course. In a similar effort to keep the astronomy classroom apprised of the fast moving field of planetary science, the Division of Planetary Sciences (DPS) has developed the Discovery slide sets, which are 3-slide presentations that can be incorporated into college lectures. The slide sets are targeted at the Introductory Astronomy undergraduate level. Each slide set consists of three slides which cover a description of the discovery, a discussion of the underlying science, and a presentation of the big picture implications of the discovery, with a fourth slide includes links to associated press releases, images, and primary sources. Topics span all subdisciplines of planetary science, and sets are available in Farsi and Spanish. The NASA SMD Planetary Science Forum has recently partnered with the DPS to continue producing the Discovery slides and connect them to NASA mission science.

EPA/NIEHS Children's Environmental Health and Disease ...

EPA Pesticide Factsheets

Powerpoint presentation - 32 slides. Introductory slides (4-5 slides); Unique Features such as the multidisciplinary Center structure, with community engagement as an integral element through the Community Outreach and Translation Cores (COTCs) (4 slides); Recent findings (Health effects of flame retardants (PBDEs)Health effects from near-road exposures, Asthma, Autism Spectrum Disorder (ASD))(4-5 slides); Impact from the work of the Centers (approx 10 Slides); Conclusion/looking forward/future activities (5 slides); A 3 minute video from one of the Children's Centers summarizing their work in the field will be shared at the end of the presentation. Dr. Johnson will be presenting the work of the EPA/NIEHS Children's Centers to Children’s Health Protection Advisory Committee (CHPAC). The Children's Health Protection Advisory Committee is a body of researchers, academicians, health care providers, environmentalists, state and tribal government employees, and members of the public who advise EPA on regulations, research, and communication issues relevant to the environmental precipitants of health in children. Members serve voluntarily and the CHPAC meets about three times per year to provide specific recommendations to the EPA Administrator. Dr. Johnson will be presenting on unique features of the Children's Centers, findings and impact from the work of the Children's Centers.

On the numerical modeling of sliding beams: A comparison of different approaches

NASA Astrophysics Data System (ADS)

Steinbrecher, Ivo; Humer, Alexander; Vu-Quoc, Loc

2017-11-01

The transient analysis of sliding beams represents a challenging problem of structural mechanics. Typically, the sliding motion superimposed by large flexible deformation requires numerical methods as, e.g., finite elements, to obtain approximate solutions. By means of the classical sliding spaghetti problem, the present paper provides a guideline to the numerical modeling with conventional finite element codes. For this purpose, two approaches, one using solid elements and one using beam elements, respectively, are employed in the analysis, and the characteristics of each approach are addressed. The contact formulation realizing the interaction of the beam with its support demands particular attention in the context of sliding structures. Additionally, the paper employs the sliding-beam formulation as a third approach, which avoids the numerical difficulties caused by the large sliding motion through a suitable coordinate transformation. The present paper briefly outlines the theoretical fundamentals of the respective approaches for the modeling of sliding structures and gives a detailed comparison by means of the sliding spaghetti serving as a representative example. The specific advantages and limitations of the different approaches with regard to accuracy and computational efficiency are discussed in detail. Through the comparison, the sliding-beam formulation, which proves as an effective approach for the modeling, can be validated for the general problem of a sliding structure subjected to large deformation.

Identify and Translate Learnings from On-Going Assay ...

EPA Pesticide Factsheets

Presentation for FDA-CFSAN ILSI workshop on State of the Science on Alternatives to Animal Testing and Integration of Testing Strategies for Food Safety Assessments Presentation for FDA-CFSAN ILSI workshop on State of the Science on Alternatives to Animal Testing and Integration of Testing Strategies for Food Safety Assessments

20170228 - Identify and Translate Learnings from On-Going ...

EPA Pesticide Factsheets

Presentation for FDA-CFSAN ILSI workshop on State of the Science on Alternatives to Animal Testing and Integration of Testing Strategies for Food Safety Assessments Presentation for FDA-CFSAN ILSI workshop on State of the Science on Alternatives to Animal Testing and Integration of Testing Strategies for Food Safety Assessments

Frequency Diverse Array Receiver Architectures

DTIC Science & Technology

2015-06-29

completely associated with FDA, the Hybrid MIMO phased array (HMPAR) concept presented in [18] developed the basic beam patern synthesis theory for an...20], that analyzed beam paterns of chirp waveforms with slightly 6 different starting frequencies. In [21] and [11] they investigated using FDA for...forward-looking radar GMTI benefits. This research showed the ability of the range-dependent energy distribution characteristics of the FDA beam patern

Sliding Mode Control of Dynamic Voltage Restorer by Using a New Adaptive Reaching Law

NASA Astrophysics Data System (ADS)

Pandey, Achala; Agrawal, Rekha; Mandloi, Ravindra S.; Sarkar, Biswaroop

2017-12-01

This paper presents a new kind of adaptive reaching law for sliding mode control of Dynamic Voltage Restorer (DVR). Such an adaptive reaching law follows under-damped sinusoidal nature that causes the initial state to reach the sliding regime in extremely less time with negligible chattering. Moreover, it is robust in the sense the trajectory does not deviate from the sliding surface. This new approach is developed and successfully applied to DVR. The simulation results are presented that show its robustness.

The Introduction of Crystallographic Concepts Using Lap-Dissolve Slide Techniques.

ERIC Educational Resources Information Center

Bodner, George M.; And Others

1980-01-01

Describes a method using lap-dissolve slide techniques with two or more slide projectors focused on a single screen for presenting visual effects that show structural features in extended arrays of atoms, or ions involving up to several hundred atoms. Presents an outline of an introduction to the structures of crystalline solids. (CS)

Alternative Films for Making Presentation Slides for the Occasional User.

ERIC Educational Resources Information Center

Hunt, Harold R., Jr.

1985-01-01

As alternatives to the well-known Kodak Kodalith film for making presentation slides, suggests using Kodak Technical Pan Film, 2415 and Kodak Precision Fine Film LPD4. Although less known, both films are capable of making excellent quality slides with minimum effort and, for the occasional user, offer advantages over the Kodalith-Diazochrome…

76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-02

... workshop will be held in the Great Room at the FDA White Oak Conference Center, Bldg. 31, Rm. 1503, 10903... requests to make oral presentations, as well as presentation materials, must be sent to the contact person... sterilization process, potentially resulting in HAIs or other adverse patient outcomes. FDA receives reports of...

Read Across Approaches: Chemical Structure and Bioactivity ...

EPA Pesticide Factsheets

Presentation for FDA-CFSAN and ILSI workshop on Workshop on State of the Science on Alternatives to Animal Testing and Integration of Testing Strategies for Food Safety Assessments Presentation for FDA-CFSAN and ILSI workshop on Workshop: State of the Science on Alternatives to Animal Testing and Integration of Testing Strategies for Food Safety Assessments

Alternative methods to determine headwater benefits

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bao, Y.S.; Perlack, R.D.; Sale, M.J.

1997-11-10

In 1992, the Federal Energy Regulatory Commission (FERC) began using a Flow Duration Analysis (FDA) methodology to assess headwater benefits in river basins where use of the Headwater Benefits Energy Gains (HWBEG) model may not result in significant improvements in modeling accuracy. The purpose of this study is to validate the accuracy and appropriateness of the FDA method for determining energy gains in less complex basins. This report presents the results of Oak Ridge National Laboratory`s (ORNL`s) validation of the FDA method. The validation is based on a comparison of energy gains using the FDA method with energy gains calculatedmore » using the MWBEG model. Comparisons of energy gains are made on a daily and monthly basis for a complex river basin (the Alabama River Basin) and a basin that is considered relatively simple hydrologically (the Stanislaus River Basin). In addition to validating the FDA method, ORNL was asked to suggest refinements and improvements to the FDA method. Refinements and improvements to the FDA method were carried out using the James River Basin as a test case.« less

[Heritage Education Lesson Plans and Slide Presentations].

ERIC Educational Resources Information Center

Van Buren, Maurie

Field tested in 27 schools and in grades four through twelve, this teaching unit stresses heritage education through the study of southern U.S. architectural styles for homes from the pioneer log structures to the 1950s ranch home. Each of the four lessons in this unit focuses around a slide presentation of 20 slides designed to fit into one…

Fast smooth second-order sliding mode control for systems with additive colored noises.

PubMed

Yang, Pengfei; Fang, Yangwang; Wu, Youli; Liu, Yunxia; Zhang, Danxu

2017-01-01

In this paper, a fast smooth second-order sliding mode control is presented for a class of stochastic systems with enumerable Ornstein-Uhlenbeck colored noises. The finite-time mean-square practical stability and finite-time mean-square practical reachability are first introduced. Instead of treating the noise as bounded disturbance, the stochastic control techniques are incorporated into the design of the controller. The finite-time convergence of the prescribed sliding variable dynamics system is proved by using stochastic Lyapunov-like techniques. Then the proposed sliding mode controller is applied to a second-order nonlinear stochastic system. Simulation results are presented comparing with smooth second-order sliding mode control to validate the analysis.

WTP Pretreatment Facility Potential Design Deficiencies--Sliding Bed and Sliding Bed Erosion Assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hansen, E. K.

2015-05-06

This assessment is based on readily available literature and discusses both Newtonian and non-Newtonian slurries with respect to sliding beds and erosion due to sliding beds. This report does not quantify the size of the sliding beds or erosion rates due to sliding beds, but only assesses if they could be present. This assessment addresses process pipelines in the Pretreatment (PT) facility and the high level waste (HLW) transfer lines leaving the PT facility to the HLW vitrification facility concentrate receipt vessel.

Presentation video retrieval using automatically recovered slide and spoken text

NASA Astrophysics Data System (ADS)

Cooper, Matthew

2013-03-01

Video is becoming a prevalent medium for e-learning. Lecture videos contain text information in both the presentation slides and lecturer's speech. This paper examines the relative utility of automatically recovered text from these sources for lecture video retrieval. To extract the visual information, we automatically detect slides within the videos and apply optical character recognition to obtain their text. Automatic speech recognition is used similarly to extract spoken text from the recorded audio. We perform controlled experiments with manually created ground truth for both the slide and spoken text from more than 60 hours of lecture video. We compare the automatically extracted slide and spoken text in terms of accuracy relative to ground truth, overlap with one another, and utility for video retrieval. Results reveal that automatically recovered slide text and spoken text contain different content with varying error profiles. Experiments demonstrate that automatically extracted slide text enables higher precision video retrieval than automatically recovered spoken text.

Section 608 Rule Presentation Slides

EPA Pesticide Factsheets

This document presents slides informing the public about updates to the Section 608 concerning appliance disposal, refrigerant reclamation, technician certification, refrigerant sales restriction, recordkeeping, and repairing refrigerant leaks.

Association of the FDA Amendment Act with trial registration, publication, and outcome reporting.

PubMed

Phillips, Adam T; Desai, Nihar R; Krumholz, Harlan M; Zou, Constance X; Miller, Jennifer E; Ross, Joseph S

2017-07-18

Selective clinical trial publication and outcome reporting has the potential to bias the medical literature. The 2007 Food and Drug Administration (FDA) Amendment Act (FDAAA) mandated clinical trial registration and outcome reporting on ClinicalTrials.gov, a publicly accessible trial registry. Using publicly available data from ClinicalTrials.gov, FDA documents, and PubMed, we determined registration, publication, and reporting of findings for all efficacy trials supporting FDA approval of new drugs for cardiovascular disease and diabetes between 2005 and 2014, before and after the FDAAA. For published trials, we compared the published interpretation of the findings (positive, equivocal, or negative) with the FDA reviewer's interpretation. Between 2005 and 2014, the FDA approved 30 drugs for 32 indications of cardiovascular disease (n = 17) and diabetes (n = 15) on the basis of 183 trials (median per indication 5.7 (IQR, 3-8)). Compared with pre FDAAA, post-FDAAA studies were more likely to be registered (78 of 78 (100%) vs 73 of 105 (70%); p < 0.001), to be published (76 of 78 (97%) vs 93 of 105 (89%); p = 0.03), and to present findings concordant with the FDA reviewer's interpretation (74 of 76 (97%) vs 78 of 93 (84%); p = 0.004). Pre FDAAA, the FDA reviewer interpreted 80 (76%) trials as positive and 91 (98%) were published as positive. Post FDAAA, the FDA reviewer interpreted 71 (91%) trials as positive and 71 (93%) were published as positive. FDAAA was associated with increased registration, publication, and FDA-concordant outcome reporting for trials supporting FDA approval of new drugs for cardiovascular disease and diabetes.

Survey of the Use of Slide/Tape Presentations for Orientation and Instruction Purposes in Academic Libraries.

ERIC Educational Resources Information Center

Hardesty, Larry

Eighty-eight academic libraries were surveyed to determine what kinds of slide/tape library instruction materials are available for purchase or loan. The conclusions reached were: (1) there are less than a dozen libraries that have produced presentations of sufficient quality and adaptability to be widely used; and (2) the slide/tape format…

Public voices in pharmaceutical deliberations: negotiating "clinical benefit" in the FDA's Avastin Hearing.

PubMed

Teston, Christa B; Graham, S Scott; Baldwinson, Raquel; Li, Andria; Swift, Jessamyn

2014-06-01

This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA's 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol's (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe's (2011) "hybrid forums," we demonstrate that the FDA's deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for "clinical benefit." Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed.

From English to Chinese, Japanese, and Russian: extending research visibility with language translations of a conference slide presentation.

PubMed

Hoffecker, Lilian; Abbey, Dana

2017-01-01

The research demonstrates that a conference slide presentation translated into non-English languages reaches significantly larger and different audiences than an English presentation alone. The slides of a presentation from the Medical Library Association annual meeting were translated from English to Chinese, Japanese, and Russian and posted along with the English version to SlideShare, an open slide-hosting website. View counts, traffic sources, and geographic origins of the traffic for each language version were tracked over a twenty-two-month period. Total view counts for all 4 language versions amounted to 3,357 views, with the Chinese version accounting for 71% of the total views. The trends in view counts over time for the Japanese, Russian, and English versions were similar, with high interest at the beginning and a rapid drop and low level of viewing activity thereafter. The pattern of view counts for the Chinese version departed considerably from the other language versions, with very low activity at the beginning but a sharp rise 10 months later. This increase in activity was related to access to the presentations via a Taiwanese website that embedded the SlideShare website code. Language translation can be a difficult and time-consuming task. However, translation of a conference slide presentation with limited text is an achievable activity and engages an international audience for information that is often not noticed or lost. Although English is by far the primary language of science and other disciplines, it is not necessarily the first or preferred language of global researchers. By offering appropriate language versions, the authors of presentations can expand the reach of their work.

The history and contemporary challenges of the US Food and Drug Administration.

PubMed

Borchers, Andrea T; Hagie, Frank; Keen, Carl L; Gershwin, M Eric

2007-01-01

The year 2006 marks the 100th anniversary of the regulatory agency now known as the US Food and Drug Administration (FDA), the first consumer protection agency of the federal government and arguably the most influential regulatory agency in the world. The FDA thus plays an integral role in the use of pharmaceuticals, not only in the United States but worldwide. The goal of this review was to present an overview of the FDA and place its current role in the perspectives of history and contemporary needs. Relevant materials for this review were identified through a search of the English-language literature indexed on MEDLINE (through 2006) using the main search terms United States Food and Drug Administration, FDA, history of the FDA, drug approvals, drug legislation, and FDA legislation. Results from the initial searches were then explored further. The statute that created the bureau which later became the FDA established this agency to prohibit interstate commerce of adulterated foods, drinks, and drugs. The Food, Drug, and Cosmetic Act that replaced it in 1938, and subsequent food and drug laws and amendments, expanded the FDA's responsibilities to cosmetics, medical devices, biological products, and radiation-emitting products. These amendments have also established the FDA as a mainly preventive regulatory agency that relies chiefly on pre-market control. As such, the FDA has played an important role in shaping the modern pharmaceutical industry by making the scientific approach and the clinical trial process the standard for establishing safety and efficacy and by making rigorous scientific analysis the predominant component of the process for pharmaceutical regulation. As shown in this review, the evolution of the FDA can be described as a series of "crisis-legislation-adaptation" cycles: a public health crisis promoted the passage of congressional legislation, which was then followed by implementation of the law by the FDA. However, the crises the FDA faces currently are likely to be overcome only under strong and permanent leadership willing to redefine the role and procedures of the FDA with an open mind.

Fast smooth second-order sliding mode control for stochastic systems with enumerable coloured noises

NASA Astrophysics Data System (ADS)

Yang, Peng-fei; Fang, Yang-wang; Wu, You-li; Zhang, Dan-xu; Xu, Yang

2018-01-01

A fast smooth second-order sliding mode control is presented for a class of stochastic systems driven by enumerable Ornstein-Uhlenbeck coloured noises with time-varying coefficients. Instead of treating the noise as bounded disturbance, the stochastic control techniques are incorporated into the design of the control. The finite-time mean-square practical stability and finite-time mean-square practical reachability are first introduced. Then the prescribed sliding variable dynamic is presented. The sufficient condition guaranteeing its finite-time convergence is given and proved using stochastic Lyapunov-like techniques. The proposed sliding mode controller is applied to a second-order nonlinear stochastic system. Simulation results are given comparing with smooth second-order sliding mode control to validate the analysis.

Continuous stacking computational approach based automated microscope slide scanner

NASA Astrophysics Data System (ADS)

Murali, Swetha; Adhikari, Jayesh Vasudeva; Jagannadh, Veerendra Kalyan; Gorthi, Sai Siva

2018-02-01

Cost-effective and automated acquisition of whole slide images is a bottleneck for wide-scale deployment of digital pathology. In this article, a computation augmented approach for the development of an automated microscope slide scanner is presented. The realization of a prototype device built using inexpensive off-the-shelf optical components and motors is detailed. The applicability of the developed prototype to clinical diagnostic testing is demonstrated by generating good quality digital images of malaria-infected blood smears. Further, the acquired slide images have been processed to identify and count the number of malaria-infected red blood cells and thereby perform quantitative parasitemia level estimation. The presented prototype would enable cost-effective deployment of slide-based cyto-diagnostic testing in endemic areas.

"Discoveries in Planetary Sciences": Slide Sets Highlighting New Advances for Astronomy Educators

NASA Astrophysics Data System (ADS)

Brain, D. A.; Schneider, N. M.; Beyer, R. A.

2010-12-01

Planetary science is a field that evolves rapidly, motivated by spacecraft mission results. Exciting new mission results are generally communicated rather quickly to the public in the form of press releases and news stories, but it can take several years for new advances to work their way into college textbooks. Yet it is important for students to have exposure to these new advances for a number of reasons. In some cases, new work renders older textbook knowledge incorrect or incomplete. In some cases, new discoveries make it possible to emphasize older textbook knowledge in a new way. In all cases, new advances provide exciting and accessible examples of the scientific process in action. To bridge the gap between textbooks and new advances in planetary sciences we have developed content on new discoveries for use by undergraduate instructors. Called 'Discoveries in Planetary Sciences', each new discovery is summarized in a 3-slide PowerPoint presentation. The first slide describes the discovery, the second slide discusses the underlying planetary science concepts, and the third presents the big picture implications of the discovery. A fourth slide includes links to associated press releases, images, and primary sources. This effort is generously sponsored by the Division for Planetary Sciences of the American Astronomical Society, and the slide sets are available at http://dps.aas.org/education/dpsdisc/. Sixteen slide sets have been released so far covering topics spanning all sub-disciplines of planetary science. Results from the following spacecraft missions have been highlighted: MESSENGER, the Spirit and Opportunity rovers, Cassini, LCROSS, EPOXI, Chandrayan, Mars Reconnaissance Orbiter, Mars Express, and Venus Express. Additionally, new results from Earth-orbiting and ground-based observing platforms and programs such as Hubble, Keck, IRTF, the Catalina Sky Survey, HARPS, MEarth, Spitzer, and amateur astronomers have been highlighted. 4-5 new slide sets are scheduled for release before December 2010. In this presentation we will discuss our motivation for this project, our implementation approach (from choosing topics to creating the slide sets, to getting them reviewed and released), and give examples of slide sets. We will present information in the form of web statistics on how many educators are using the slide sets, and which topics are most popular. We will also present feedback from educators who have used them in the classroom, and possible new directions for our activity.

Modelling the initiation of basal sliding

NASA Astrophysics Data System (ADS)

Mantelli, E.; Schoof, C.

2017-12-01

The initiation of basal sliding is a thermally-controlled process that affects ice speed, englacial heat transport, and melt water production at the bed, and ultimately influences the large-scale dynamics of ice sheets. From a modelling perspective, describing the onset of sliding in thin-film models suitable for ice sheet scale simulations is problematic. In particular, previous work concluded that, under shallow-ice mechanics, the scenario of a hard switch from frozen to molten bed leads to an infinite vertical velocity at the onset, and higher-order mechanical formulations are needed to describe sliding initiation. An alternative view considers the occurrence of subtemperate sliding, which allows for a smooth sliding velocity across the onset. However, the sliding velocity decreases rapidly as temperature drops below the melting point, thus raising the issue of whether a mechanical model that does not resolve the ice sheet thickness scale is ever appropriate to model the onset of sliding. In this study we first present a boundary layer model for the hard switch scenario. Our analysis, which considers a thermo-mechanically coupled Stokes flow near the onset, shows that the abrupt onset of sliding is never possible. In fact, the acceleration of ice flow deflects the flowlines towards the bed, which freezes again immediately downstream to the onset. This leads to the conclusion that the sliding velocity must change smoothly across the onset, thus the temperature dependence of sliding needs to be taken into account. In this context, we examine a limiting case of standard temperature-dependent sliding laws, where sliding onset takes the form of an extended transition region interposed between fully frozen and temperate bed. In the transition region basal temperature is at the melting point, and the sliding velocity varies smoothly as dictated by the energy budget of the bed. As the extent of this region is not small compared to the ice sheet length scale, we couple this description of sliding initiation to a shallow-ice model, which is appropriate so long as sliding velocities are not large. We present numerical and analytical results concerning the steady states and the stability of this ice sheet model, and discuss implications of sliding initiation with respect to pattern formation.

Slide system for machine tools

DOEpatents

Douglass, S.S.; Green, W.L.

1980-06-12

The present invention relates to a machine tool which permits the machining of nonaxisymmetric surfaces on a workpiece while rotating the workpiece about a central axis of rotation. The machine tool comprises a conventional two-slide system (X-Y) with one of these slides being provided with a relatively short travel high-speed auxiliary slide which carries the material-removing tool. The auxiliary slide is synchronized with the spindle speed and the position of the other two slides and provides a high-speed reciprocating motion required for the displacement of the cutting tool for generating a nonaxisymmetric surface at a selected location on the workpiece.

Slide system for machine tools

DOEpatents

Douglass, Spivey S.; Green, Walter L.

1982-01-01

The present invention relates to a machine tool which permits the machining of nonaxisymmetric surfaces on a workpiece while rotating the workpiece about a central axis of rotation. The machine tool comprises a conventional two-slide system (X-Y) with one of these slides being provided with a relatively short travel high-speed auxiliary slide which carries the material-removing tool. The auxiliary slide is synchronized with the spindle speed and the position of the other two slides and provides a high-speed reciprocating motion required for the displacement of the cutting tool for generating a nonaxisymmetric surface at a selected location on the workpiece.

Evidentiary Support in Public Comments to the FDA's Center for Tobacco Products.

PubMed

Hemmerich, Natalie; Klein, Elizabeth G; Berman, Micah

2017-08-01

Electronic Nicotine Delivery Systems (ENDS) were introduced into the US market in 2007, and until recently these devices were unregulated at the federal level. In 2014, the US Food and Drug Administration (FDA) published a Notice of Proposed Rulemaking asserting its intention to regulate ENDS and requesting public comments on numerous related issues, including potential limits on the sale of flavored ENDS. This article analyzes key comments submitted to the FDA on the issue of flavor regulation in ENDS and examines the weight and credibility of the evidence presented by both supporters and opponents of regulation. It also describes the final deeming rule, published in May 2016, and the FDA's response to the evidence submitted. This is the first study to examine public comments submitted to the FDA's Center for Tobacco Products, and it concludes that opponents of regulation were more likely to rely on sources that were not peer reviewed and that were affected by conflicts of interest. In light of these findings, the FDA and the research community should develop processes to carefully and critically analyze public comments submitted to the FDA on issues of tobacco regulation. Copyright © 2017 by Duke University Press.

Adaptive Actor-Critic Design-Based Integral Sliding-Mode Control for Partially Unknown Nonlinear Systems With Input Disturbances.

PubMed

Fan, Quan-Yong; Yang, Guang-Hong

2016-01-01

This paper is concerned with the problem of integral sliding-mode control for a class of nonlinear systems with input disturbances and unknown nonlinear terms through the adaptive actor-critic (AC) control method. The main objective is to design a sliding-mode control methodology based on the adaptive dynamic programming (ADP) method, so that the closed-loop system with time-varying disturbances is stable and the nearly optimal performance of the sliding-mode dynamics can be guaranteed. In the first step, a neural network (NN)-based observer and a disturbance observer are designed to approximate the unknown nonlinear terms and estimate the input disturbances, respectively. Based on the NN approximations and disturbance estimations, the discontinuous part of the sliding-mode control is constructed to eliminate the effect of the disturbances and attain the expected equivalent sliding-mode dynamics. Then, the ADP method with AC structure is presented to learn the optimal control for the sliding-mode dynamics online. Reconstructed tuning laws are developed to guarantee the stability of the sliding-mode dynamics and the convergence of the weights of critic and actor NNs. Finally, the simulation results are presented to illustrate the effectiveness of the proposed method.

Using the General Mission Analysis Tool (GMAT)

NASA Technical Reports Server (NTRS)

Hughes, Steven P.; Conway, Darrel J.; Parker, Joel

2017-01-01

This is a software tutorial and presentation demonstrating the application of the General Mission Analysis Tool (GMAT). These slides will be used to accompany the demonstration. The demonstration discusses GMAT basics, then presents a detailed example of GMAT application to the Transiting Exoplanet Survey Satellite (TESS) mission. This talk is a combination of existing presentations and material; system user guide and technical documentation; a GMAT basics and overview, and technical presentations from the TESS projects on their application of GMAT to critical mission design. The GMAT basics slides are taken from the open source training material. The TESS slides are a streamlined version of the CDR package provided by the project with SBU and ITAR data removed by the TESS project. Slides for navigation and optimal control are borrowed from system documentation and training material.

The Easy Way to Create Computer Slide Shows.

ERIC Educational Resources Information Center

Anderson, Mary Alice

1995-01-01

Discusses techniques for creating computer slide shows. Topics include memory; format; color use; HyperCard and CD-ROM; font styles and sizes; graphs and graphics; the slide show option; special effects; and tips for effective presentation. (Author/AEF)

[Effects of Drugs Given During Pregnancy and Lactation on the Unborn Child and Neonate.

ERIC Educational Resources Information Center

Kelsey, Frances O.

This symposium presentation outlines the activity of the Food and Drug Administration (FDA) in regulating the use during pregnancy and lactation of drugs which affect the fetus and neonate. When presented with an unexpected adverse effect of a drug or of a class of drugs, the FDA can take several steps. These steps include ordering total removal…

Water and the Thirsting Spirit.

ERIC Educational Resources Information Center

Najem, Robert E.

1984-01-01

Highlights a four-part slide show focusing on the humanistic legacy of water: (1) water in literature; (2) architecture; (3) religion; and (4) painting. Discusses representative slides in each category and presents a complete list of all slides that comprise the program. (BC)

Terminal sliding mode tracking control for a class of SISO uncertain nonlinear systems.

PubMed

Chen, Mou; Wu, Qing-Xian; Cui, Rong-Xin

2013-03-01

In this paper, the terminal sliding mode tracking control is proposed for the uncertain single-input and single-output (SISO) nonlinear system with unknown external disturbance. For the unmeasured disturbance of nonlinear systems, terminal sliding mode disturbance observer is presented. The developed disturbance observer can guarantee the disturbance approximation error to converge to zero in the finite time. Based on the output of designed disturbance observer, the terminal sliding mode tracking control is presented for uncertain SISO nonlinear systems. Subsequently, terminal sliding mode tracking control is developed using disturbance observer technique for the uncertain SISO nonlinear system with control singularity and unknown non-symmetric input saturation. The effects of the control singularity and unknown input saturation are combined with the external disturbance which is approximated using the disturbance observer. Under the proposed terminal sliding mode tracking control techniques, the finite time convergence of all closed-loop signals are guaranteed via Lyapunov analysis. Numerical simulation results are given to illustrate the effectiveness of the proposed terminal sliding mode tracking control. Copyright © 2012 ISA. Published by Elsevier Ltd. All rights reserved.

Problems caused by regulatory delays and lack of regulation

NASA Astrophysics Data System (ADS)

Reamer, Lynne A.

1994-12-01

An FDA perspective on some of the problems encountered during the device review process is described. Emphasis is placed on the need for communication and teamwork among all parties to make the system work. Manufacturers are encouraged to `Do it right the first time.' Pertinent questions are asked of the manufacturers and proposed solutions are presented. Day to day reality at FDA is described and document workload is revealed. Lack of regulation, or more appropriately, when less regulation is appropriate is discussed. FDA has distributed to manufacturers a new draft guidance document to help in the decisionmaking process and when to submit a 510(k) when modifications are made to a device. This and other mechanisms are in place at the FDA to streamline the review process. Manufacturers are cautioned about their decisions and to seek advice from qualified persons. FDA emphasizes that help is available and that when in doubt, call.

Human factors and the FDA's goals: improved medical device design.

PubMed

Burlington, D B

1996-01-01

The Food and Drug Administration's new human factors design requirements for medical devices were previewed by the director of the FDA's Center for Devices and Radiological Health (CDRH) at AAMI/FDA's Human Factors in Medical Devices Conference held in September 1995. Director Bruce Burlington, MD, said the FDA plans to take a closer look at how new medical devices are designed to ensure proper attention has been paid to human error prevention. As a medical practitioner who has witnessed use-related deaths and injuries, Burlington stressed the importance of the medical community's reporting use errors as they occur and manufacturers' creating easy-to-use labeling and packaging. He also called for simplicity and quality of design in medical products, and asked for a consolidated effort of all professionals involved in human factors issues to help implement and further the FDA's new human factors program. An edited version of his presentation appears here.

Preparing Scientific Papers, Posters, and Slides.

PubMed

Lefor, Alan Kawarai; Maeno, Misato

2016-01-01

Publications and presentations are important in academic medicine. The ability to present information in a standard fashion is critically important. Papers, posters, and slides must be prepared appropriately to maximize their chance of being accepted. The first step is to use word processing software correctly. English language usage must conform to standard scientific English usage. Abbreviations should be avoided as much as possible. Numerical data must be presented with the appropriate number of significant figures. The first step in preparing a paper is to decide the target journal. Papers should always be written in 12 point Times New Roman font, while slides and posters should be in Arial or Helvetica. The Results section must contain actual data with appropriate statistical analysis. Take great care to prepare figures and tables according to the journal's instructions. Posters must be prepared to allow easy reading at a distance of 2m. Use a white background and dark letters. The majority of the area of your poster should be Results, and there is no need to include the abstract or references on a poster. Slide presentations should be limited to about one slide for each minute of the talk. Avoid the use of animations and excessive use of color. Do not use abbreviations on slides. Following these simple guidelines will meet the requirements of most journals and allow your audience to appreciate the data on your posters and slides. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Analysis and Synthesis of Memory-Based Fuzzy Sliding Mode Controllers.

PubMed

Zhang, Jinhui; Lin, Yujuan; Feng, Gang

2015-12-01

This paper addresses the sliding mode control problem for a class of Takagi-Sugeno fuzzy systems with matched uncertainties. Different from the conventional memoryless sliding surface, a memory-based sliding surface is proposed which consists of not only the current state but also the delayed state. Both robust and adaptive fuzzy sliding mode controllers are designed based on the proposed memory-based sliding surface. It is shown that the sliding surface can be reached and the closed-loop control system is asymptotically stable. Furthermore, to reduce the chattering, some continuous sliding mode controllers are also presented. Finally, the ball and beam system is used to illustrate the advantages and effectiveness of the proposed approaches. It can be seen that, with the proposed control approaches, not only can the stability be guaranteed, but also its transient performance can be improved significantly.

Qualification test unit slide stainer (Beckman P/N 673753)

NASA Technical Reports Server (NTRS)

Bernier, P. S.

1972-01-01

Specifications for a slide stainer unit for the Skylab program are presented. The qualification test slide stainer was designed to be a self-contained system capable of performing an eight-step Gram stain of microorganisms and a Wright's stain of blood smears.

Determining the Ecosystem Services Important for Urban Landscapes-Slides

EPA Science Inventory

This presentation consists of introductory slides on ecosystem services in urban landscapes and then a discussion of two case studies concerning the provision of water quality in urban landscapes. The introductory slides will explore the range of ecosystem services provided by u...

Continuing Medical Education Speakers with High Evaluation Scores Use more Image-based Slides.

PubMed

Ferguson, Ian; Phillips, Andrew W; Lin, Michelle

2017-01-01

Although continuing medical education (CME) presentations are common across health professions, it is unknown whether slide design is independently associated with audience evaluations of the speaker. Based on the conceptual framework of Mayer's theory of multimedia learning, this study aimed to determine whether image use and text density in presentation slides are associated with overall speaker evaluations. This retrospective analysis of six sequential CME conferences (two annual emergency medicine conferences over a three-year period) used a mixed linear regression model to assess whether post-conference speaker evaluations were associated with image fraction (percentage of image-based slides per presentation) and text density (number of words per slide). A total of 105 unique lectures were given by 49 faculty members, and 1,222 evaluations (70.1% response rate) were available for analysis. On average, 47.4% (SD=25.36) of slides had at least one educationally-relevant image (image fraction). Image fraction significantly predicted overall higher evaluation scores [F(1, 100.676)=6.158, p=0.015] in the mixed linear regression model. The mean (SD) text density was 25.61 (8.14) words/slide but was not a significant predictor [F(1, 86.293)=0.55, p=0.815]. Of note, the individual speaker [χ 2 (1)=2.952, p=0.003] and speaker seniority [F(3, 59.713)=4.083, p=0.011] significantly predicted higher scores. This is the first published study to date assessing the linkage between slide design and CME speaker evaluations by an audience of practicing clinicians. The incorporation of images was associated with higher evaluation scores, in alignment with Mayer's theory of multimedia learning. Contrary to this theory, however, text density showed no significant association, suggesting that these scores may be multifactorial. Professional development efforts should focus on teaching best practices in both slide design and presentation skills.

A Day in the Life of an Industrial Hearing Conservationist: A Template for Successful Career Education and Outreach Presentations

NASA Technical Reports Server (NTRS)

Cooper, Beth A.

1997-01-01

Whether in a classroom setting or at a local community meeting, opportunities for providing descriptive and positive information about our professions to an audience unfamiliar with acoustics, noise control or hearing conservation often call for alternatives to technical demonstrations that illustrate principles of acoustics or noise control. More importantly, successful outreach presentations must convey images of our day-to-day activities and the challenges we address, many of which are non-technical. One successful approach to career outreach presentations makes use of a collection of photo slides featuring the speaker, his colleagues, customers and workplaces to vividly illustrate the specific job tasks, people and environment of the speaker's job or career. Against this fluid and multi-dimensional visual backdrop, an accompanying script addresses the main theme. A comprehensive photo slide collection may be established gradually, often by making use of and adding to technical and personal slides already in the speaker's possession. Slide collections are portable, easily and quickly reconfigured for back-to-back or spontaneous engagements, and they are well suited to speaking opportunities where technical presentations or demonstrations are not practical or appropriate. A carefully chosen sequence of photo slides minimizes the need for speaker's notes, as each photo itself provides a visual prompt. Although photo slide presentations are appropriate to a variety of outreach and professional settings, the specific illustrative and explanatory material presented here illustrates their application in career education outreach activities, using industrial hearing conservation as an example.

Evaluation of efficacy of heartworm preventive products at the FDA.

PubMed

Hampshire, Victoria A

2005-10-24

The Center for Veterinary Medicine, U.S. Food and Drug Administration (FDA/CVM) has authority under the United States Code 21 under Section 514.80 to monitor for adverse experiences of approved animal products. Although veterinarians voluntarily report suspect drug-related events to manufacturers, firms that market FDA-approved animal products must report serious events to the FDA within 15 working days of the veterinarian or pet-owner's call to them. Under the present regulations, canine heartworm preventatives are approved for 100% efficacy after testing in laboratory and field conditions. The report of lack of efficacy against heartworm larvae is a serious adverse drug event because the resulting condition or the treatment of the condition is life threatening. Information on lack of effect that are deemed possibly, probably, or definitely drug-related available for review under generic product on the FDA/CVM website Surveillance of these reports indicates there are some failures for virtually all heartworm prevention product categories. Most failures have been reported in heartworm-endemic states. At this time, it is unclear whether these are representative of the rare occurrences of failure that have been in existence for a long time, but not reported regularly or promptly, or whether there is a true increase in complaints of ineffectiveness and real variability between products. This paper discusses methods, personnel, and procedures in place in the Division of Surveillance that will aid the FDA to better assess heartworm preventive treatment failures. It discusses scoring paradigms presently utilized by FDA/CVM to assess severity of complaints of lack of efficacy against heartworms, and welcomes audience input as to how to improve existing processes. Results suggest that more comprehensive reporting will provide FDA/CVM more accurate surveillance information regarding efficacy problems. Such practices will permit FDA/CVM to better interpret both incidence and severity of in-effect and possible patterns of emerging resistance and to convey this in any necessary updated labeling. It also indicates that as part of that process, practitioners should return to a more conservative testing schedule.

Projector Center: Slide-Tape Presentations on a Classroom Budget.

ERIC Educational Resources Information Center

Barman, Charles R., Ed.

1984-01-01

Presented is a recommended sequence for developing a slide-tape presentation. Steps include selecting a topic, determining objectives for the presentation, constructing a storyboard, writing the script, and recording the script. Comments on use of quotation, sound effects, built-in pauses, and use of student voices are included. (JN)

Sliding Mode Control for Discrete-Time Systems With Markovian Packet Dropouts.

PubMed

Song, Heran; Chen, Shih-Chi; Yam, Yeung

2017-11-01

This paper presents the design of a sliding mode controller for networked control systems subject to successive Markovian packet dropouts. This paper adopts the Gilbert-Elliott channel model to describe the temporal correlation among packet losses, and proposes an update scheme to select the assumed available states for use in a sliding mode control law. A technique used in the theory of discrete-time Markov jump linear systems is applied to tackle the effect of the packet losses. This involves introducing a couple of Lyapunov functions dependent on the indicator functions of the instantaneous packet loss, and proving that the sliding mode controller is able to drive the system state trajectories into the neighborhood of the designed integral sliding surface in mean-square sense given that the corresponding Lyapunov inequalities are satisfied. The system is guaranteed thereafter to remain inside the neighborhood of the sliding surface. Simulated case studies are presented to illustrate the effectiveness of the control law.

Web-based oil immersion whole slide imaging increases efficiency and clinical team satisfaction in hematopathology tumor board

PubMed Central

Chen, Zhongchuan Will; Kohan, Jessica; Perkins, Sherrie L.; Hussong, Jerry W.; Salama, Mohamed E.

2014-01-01

Background: Whole slide imaging (WSI) is widely used for education and research, but is increasingly being used to streamline clinical workflow. We present our experience with regard to satisfaction and time utilization using oil immersion WSI for presentation of blood/marrow aspirate smears, core biopsies, and tissue sections in hematology/oncology tumor board/treatment planning conferences (TPC). Methods: Lymph nodes and bone marrow core biopsies were scanned at ×20 magnification and blood/marrow smears at 83X under oil immersion and uploaded to an online library with areas of interest to be displayed annotated digitally via web browser. Pathologist time required to prepare slides for scanning was compared to that required to prepare for microscope projection (MP). Time required to present cases during TPC was also compared. A 10-point evaluation survey was used to assess clinician satisfaction with each presentation method. Results: There was no significant difference in hematopathologist preparation time between WSI and MP. However, presentation time was significantly less for WSI compared to MP as selection and annotation of slides was done prior to TPC with WSI, enabling more efficient use of TPC presentation time. Survey results showed a significant increase in satisfaction by clinical attendees with regard to image quality, efficiency of presentation of pertinent findings, aid in clinical decision-making, and overall satisfaction regarding pathology presentation. A majority of respondents also noted decreased motion sickness with WSI. Conclusions: Whole slide imaging, particularly with the ability to use oil scanning, provides higher quality images compared to MP and significantly increases clinician satisfaction. WSI streamlines preparation for TPC by permitting prior slide selection, resulting in greater efficiency during TPC presentation. PMID:25379347

DPS Discovery Slide Sets for the Introductory Astronomy Instructor

NASA Astrophysics Data System (ADS)

Meinke, Bonnie K.; Jackson, Brian; Buxner, Sanlyn; Horst, Sarah; Brain, David; Schneider, Nicholas M.

2016-10-01

The DPS actively supports the E/PO needs of the society's membership, including those at the front of the college classroom. The DPS Discovery Slide Sets are an opportunity for instructors to put the latest planetary science into their lectures and for scientists to get their exciting results to college students.In an effort to keep the astronomy classroom apprised of the fast moving field of planetary science, the Division for Planetary Sciences (DPS) has developed "DPS Discoveries", which are 3-slide presentations that can be incorporated into college lectures. The slide sets are targeted at the Introductory Astronomy undergraduate level. Each slide set consists of three slides which cover a description of the discovery, a discussion of the underlying science, and a presentation of the big picture implications of the discovery, with a fourth slide that includes links to associated press releases, images, and primary sources. Topics span all subdisciplines of planetary science, and 26 sets are available in Farsi and Spanish. We intend for these slide sets to help Astronomy 101 instructors include new developments (not yet in their textbooks) into the broader context of the course. If you need supplemental material for your classroom, please checkout the archived collection: http://dps.aas.org/education/dpsdiscMore slide sets are now in development and will be available soon! In the meantime, we seek input, feedback, and help from the DPS membership to add fresh slide sets to the series and to connect the college classroom to YOUR science. It's easy to get involved - we'll provide a content template, tips and tricks for a great slide set, and pedagogy reviews. Talk to a coauthor to find out how you can disseminate your science or get involved in E/PO with your contributions.

Sliding wear and friction behaviour of zircaloy-4 in water

NASA Astrophysics Data System (ADS)

Sharma, Garima; Limaye, P. K.; Jadhav, D. T.

2009-11-01

In water cooled nuclear reactors, the sliding of fuel bundles in fuel channel handling system can lead to severe wear and it is an important topic to study. In the present study, sliding wear behaviour of zircaloy-4 was investigated in water (pH ˜ 10.5) using ball-on-plate sliding wear tester. Sliding wear resistance zircaloy-4 against SS 316 was examined at room temperature. Sliding wear tests were carried out at different load and sliding frequencies. The coefficient of friction of zircaloy-4 was also measured during each tests and it was found to decrease slightly with the increase in applied load. The micro-mechanisms responsible for wear in zircaloy-4 were identified to be microcutting, micropitting and microcracking of deformed subsurface zones in water.

Improved Coast Guard Communications Using Commercial Satellites and WWW Technology: Slide Presentation

DOT National Transportation Integrated Search

1997-06-18

The slides in this file amplify a paper that was presented at International Mobile Satellite Conference, (IMSC-97), Pasadena CA on 18 June 1997. The text of that presentation can be found at http://www.bts.gov/NTL/data/imsc.pdf.

A Simple Measurement of the Sliding Friction Coefficient

ERIC Educational Resources Information Center

Gratton, Luigi M.; Defrancesco, Silvia

2006-01-01

We present a simple computer-aided experiment for investigating Coulomb's law of sliding friction in a classroom. It provides a way of testing the possible dependence of the friction coefficient on various parameters, such as types of materials, normal force, apparent area of contact and sliding velocity.

A Computer System for Making Quick and Economical Color Slides.

ERIC Educational Resources Information Center

Pryor, Harold George

1986-01-01

A computer-based method for producing 35mm color slides has been used in Ohio State University's College of Dentistry. The method can produce both text and slides in less than two hours, providing substantial flexibility in planning and revising visual presentations. (Author/MLW)

77 FR 26768 - Food and Drug Administration/International Society for Pharmaceutical Engineering Cosponsorship...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

... year, FDA speakers provide updates on current efforts affecting the development of global regulatory strategies, while industry professionals from some of today's leading pharmaceutical companies present case... hear directly from FDA experts and representatives of global regulatory authorities on best practices...

World petroleum assessment 2000; compiled PowerPoint slides

USGS Publications Warehouse

Ahlbrandt, Thomas S.

2001-01-01

The slides in this compilation have been produced for a number of presentations on the World Petroleum Assessment 20000. Many of the figures are taken directly form the publication "U.S. Geological Survey World Petroleum Assessment 2000" - Description and Results: USGS Digital Data Series DDS-60, 2000. Some of the slides are modifications of figures from DDS-60, some are new descriptive slides, and a few are new slides. Several of the slides appear to be duplicates, but in fact are slight modifications for format or content from the same image. Forty-one people participated in this effort as part of the World Energy Assessment Team. The full list of contributors is given ion DDS-60. 

Digital and traditional slides for teaching cellular morphology: a comparative analysis of learning outcomes.

PubMed

Solberg, Brooke L

2012-01-01

Recent advances in technology have brought forth an intriguing new tool for teaching hematopoietic cellular identification skills: the digital slide. Although digitized slides offer a number of appealing options for educators, little research has been done to examine how their utilization would impact learning outcomes. To fill that void, this study was designed to examine student performance, skill retention and transferability, and self-efficacy beliefs amongst undergraduate MLS students learning cellular morphology with digital versus traditional slides. Results showed that students learning with digital slides performed better on assessments containing only traditional slide specimens than students learning with traditional slides, both immediately following the learning activity and after a considerable duration of time. Students learning with digital slides also reported slightly higher levels of self-efficacy related to cellular identification. The findings of this study suggest that students learning cellular identification skills with digital slides are able to transfer that skill directly to traditional slides, and that their ability to identify cells is not negatively affected in present or future settings.

The Munson-Nygren slide: A major lower-slope slide off Georges Bank

USGS Publications Warehouse

O'Leary, Dennis W.

1986-01-01

The Munson-Nygren slide is a large compound slide located between Munson and Nygren Canyons below 1900 m depth on the Continental Slope off Georges Bank. Its structural and morphological features are recognized in high-resolution seismic-reflection profiles. The slide comprises an axial trough which has a relief as great as 325 m and a width of 6-10 km. The trough is flanked by displaced and disrupted strata for a total lateral extent of approximately 20 km and a downslope extent of at least 35 km. The slide is unrelated genetically to the adjacent canyons and may postdate Munson Canyon. There is evidence of plastic deformation at the base of the section subjected to sliding. Certain features of the slide complex resemble those seen in landforms on the Laurentian Rise and attributed by Emery et al.* * Emery et al. (1970). to the 1929 Grand Banks earthquake. The Munson-Nygren slide may have been triggered by a large earthquake in late Pleistocene time or later. Destructional landforms associated with the slide are similar to those widely present along the lower slope off Georges Bank. ?? 1986.

Application of ToxCast High-Throughput Screening and ...

EPA Pesticide Factsheets

Slide presentation at the SETAC annual meeting on High-Throughput Screening and Modeling Approaches to Identify Steroidogenesis Distruptors Slide presentation at the SETAC annual meeting on High-Throughput Screening and Modeling Approaches to Identify Steroidogenssis Distruptors

Intracellular esterase activity in living cells may distinguish between metastatic and tumor-free lymph nodes.

PubMed

Afrimzon, Elena; Deutsch, Assaf; Shafran, Yana; Zurgil, Naomi; Sandbank, Judith; Pappo, Itzhak; Deutsch, Mordechai

2008-01-01

One of the major clinical problems in breast cancer detection is the relatively high incidence of occult lymph node metastases undetectable by standard procedures. Since the ascertainment of breast cancer stage determines the following treatment, such a "hypo-diagnosis" leads to inadequate therapy, and hence is detrimental for the outcome and survival of the patients. The purpose of our study was to investigate functional metabolic characteristics of living cells derived from metastatic and tumor-free lymph nodes of breast cancer (BC) patients. Our methodology is based on the ability of living cells to hydrolyze fluorescein diacetate (FDA) by intracellular esterases and on the association of FDA hydrolysis rates with a specific cell status, both in physiological and pathological conditions. The present study demonstrates a significant difference in the ability to utilize FDA by lymph node cells derived from metastatic and tumor-free lymph nodes in general average, as well as in the metastatic and tumor-free lymph nodes of individual patients. Cells from metastatic lymph nodes had a higher capacity for FDA hydrolysis, and increased this activity after additional activation by autologous tumor tissue (tt). The association between increased FDA hydrolysis rate and activated T lymphocytes and antigen-presenting cells (APC) was shown. The results of the present study may contribute to predicting the risk of involvement of seemingly "tumor-free" axillary lymph nodes in occult metastatic processes, and to reducing false-negative results of axillary examination.

Suicidality and risk of suicide--definition, drug safety concerns, and a necessary target for drug development: a brief report.

PubMed

Meyer, Roger E; Salzman, Carl; Youngstrom, Eric A; Clayton, Paula J; Goodwin, Frederick K; Mann, J John; Alphs, Larry D; Broich, Karl; Goodman, Wayne K; Greden, John F; Meltzer, Herbert Y; Normand, Sharon-Lise T; Posner, Kelly; Shaffer, David; Oquendo, Maria A; Stanley, Barbara; Trivedi, Madhukar H; Turecki, Gustavo; Beasley, Charles M; Beautrais, Annette L; Bridge, Jeffrey A; Brown, Gregory K; Revicki, Dennis A; Ryan, Neal D; Sheehan, David V

2010-08-01

To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009. This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies in studies of psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest. Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted. Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this brief report and the accompanying full article from which it is distilled. The full article was developed by the authors with feedback from all participants at the meeting and represents a consensus view. Any areas of disagreement at the conference have been noted in the text. The term suicidality is not as clinically useful as more specific terminology (ideation, behavior, attempts, and suicide). Most participants applauded the FDA's encouragement of standard definitions and definable expectations for investigators and industry sponsors. Further research of available assessment instruments is needed to verify their utility, reliability, and validity in identifying suicide-associated treatment-emergent adverse effects and/or a signal of efficacy in suicide prevention trials. The FDA needs to systematically monitor postmarketing events by encouraging the development of a validated instrument for postmarketing surveillance of suicidal ideation, behavior, and risk. Over time, the FDA, industry, and clinical researchers should evaluate the impact of the requirement that all central nervous system clinical drug trials must include a Columbia Classification Algorithm of Suicide Assessment (C-CASA)-compatible screening instrument for assessing and documenting the occurrence of treatment-emergent suicidal ideation and behavior. Finally, patients at high risk for suicide can safely be included in clinical trials, if proper precautions are followed. Copyright 2010 Physicians Postgraduate Press, Inc.

Community Air Sensor Network CAIRSENSE Project: Lower ...

EPA Pesticide Factsheets

Presentation slides on the CAIRSENSE project, Atlanta field study testing low cost air sensors against FEM instruments. To be presented at the Air and Waste Management Association conference. Presentation slides on the CAIRSENSE project, Atlanta field study testing low cost air sensors against FEM instruments. To be presented at the Air and Waste Management Association conference.

Improving Student Group Marketing Presentations: A Modified Pecha Kucha Approach

ERIC Educational Resources Information Center

Oliver, Jason; Kowalczyk, Christine

2013-01-01

Student presentations can often seem like a formality rather than a lesson in representing oneself or group in a professional manner. To improve the quality of group presentations, the authors modified the popular presentation style of Pecha Kucha (20 slides, 20 seconds per slide) for marketing courses to help students prepare and deliver…

Thin Film Solid Lubricant Development

NASA Technical Reports Server (NTRS)

Benoy, Patricia A.

1997-01-01

Tribological coatings for high temperature sliding applications are addressed. A sputter-deposited bilayer coating of gold and chromium is investigated as a potential solid lubricant for protection of alumina substrates during sliding at high temperature. Evaluation of the tribological properties of alumina pins sliding against thin sputtered gold films on alumina substrates is presented.

Optimizing Student Learning: Examining the Use of Presentation Slides

ERIC Educational Resources Information Center

Strauss, Judy; Corrigan, Hope; Hofacker, Charles F.

2011-01-01

Sensory overload and split attention result in reduced learning when instructors read slides with bullet points and complex graphs during a lecture. Conversely, slides containing relevant visual elements, when accompanied by instructor narration, use both the visual and verbal channels of a student's working memory, thus improving the chances of…

A novel glass slide filing system for pathology slides.

PubMed

Tsai, Steve; Kartono, Francisca; Shitabata, Paul K

2007-07-01

The availability of a collection of microscope glass slides for review is essential in the study and practice of pathology. A common problem facing many pathologists is the lack of a well-organized filing system. We present a novel system that would be easily accessible, informative, protective, and portable.

Kidney removal - slideshow

MedlinePlus

... this page: //medlineplus.gov/ency/presentations/100069.htm Kidney removal (nephrectomy) - series—Normal anatomy To use the sharing features on this page, please enable JavaScript. Go to slide 1 out of 5 Go to slide 2 out of ... to slide 5 out of 5 Overview The kidneys are paired organs that lie posterior to the ...

The educational potential of direct-to-consumer prescription drug advertising.

PubMed

Kaphingst, Kimberly A; DeJong, William

2004-01-01

Food and Drug Administration (FDA) regulations for direct-to-consumer (DTC) prescription drug advertising allow broadcast advertisements with incomplete risk information if the ads refer consumers to physicians, pharmacists, and supplemental information sources. New research reveals several problems with both television advertisements and supplemental text materials that might compromise their ability to meet the FDA's requirement for "fair balance" in the presentation of risks and benefits. In response, we make several recommendations to improve the educational quality of DTC advertising, which can be implemented through either voluntary agreements or revised FDA regulations.

76 FR 43847 - Poison Prevention Packaging Requirements; Exemption of Powder Formulations of Colesevelam...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

... FDA-regulated drug, biologic, medical device, dietary supplement, or cosmetic. (See http://www.fda.gov... powders generally present a low risk because they are more difficult to ingest, particularly in large quantities. Generally, with the exception of caustics, the primary exposure risk associated with powders is...

The experiment research of the friction sliding isolation structure

NASA Astrophysics Data System (ADS)

Zhang, Shirong; Li, Jiangle; Wang, Sheliang

2018-04-01

This paper investigated the theory of the friction sliding isolation structure, The M0S2 solid lubricant was adopted as isolation bearing friction materials, and a new sliding isolation bearing was designed and made. The formula of the friction factor and the compression stress was proposed. The feasibility of the material MoS2 used as the coating material in a friction sliding isolation system was tested on the 5 layers concrete frame model. Two application experiment conditions were presented. The results of the experiment research indicated that the friction sliding isolation technology have a good damping effect.

Backstepping sliding mode control with functional tuning based on an instantaneous power approach applied to an underwater vehicle

NASA Astrophysics Data System (ADS)

Santos, Carlos Henrique Farias dos; Cildoz, Mariana Uzeda; Terra, Marco Henrique; De Pieri, Edson Roberto

2018-03-01

In this paper, we present a modified backstepping sliding mode control to deal with Euler-Lagrange systems. The controller is applied in an underwater vehicle in order to show the effectiveness of the approach proposed. Instantaneous power data provided by the propulsion system are used to tune the controller in order to guarantee robust performance and energy saving. Thanks to the combination of an internal Proportional Integral and Derivative (PID) controller, it is possible implement high gains to deal with the influence of disturbances and uncertainties. A comparative study among this backstepping sliding mode controller and standard sliding mode controls is presented.

Sliding Mode Thermal Control System for Space Station Furnace Facility

NASA Technical Reports Server (NTRS)

Jackson Mark E.; Shtessel, Yuri B.

1998-01-01

The decoupled control of the nonlinear, multiinput-multioutput, and highly coupled space station furnace facility (SSFF) thermal control system is addressed. Sliding mode control theory, a subset of variable-structure control theory, is employed to increase the performance, robustness, and reliability of the SSFF's currently designed control system. This paper presents the nonlinear thermal control system description and develops the sliding mode controllers that cause the interconnected subsystems to operate in their local sliding modes, resulting in control system invariance to plant uncertainties and external and interaction disturbances. The desired decoupled flow-rate tracking is achieved by optimization of the local linear sliding mode equations. The controllers are implemented digitally and extensive simulation results are presented to show the flow-rate tracking robustness and invariance to plant uncertainties, nonlinearities, external disturbances, and variations of the system pressure supplied to the controlled subsystems.

Ensuring the safe and effective FDA regulation of fecal microbiota transplantation

PubMed Central

Sachs, Rachel E.; Edelstein, Carolyn A.

2015-01-01

Scientists, policymakers, and medical professionals alike have become increasingly worried about the rise of antibiotic resistance, and the growing number of infections due to bacteria like Clostridium difficile, which cause a significant number of deaths and are imposing increasing costs on our health care system. However, in the last few years, fecal microbiota transplantation (FMT), the transplantation of stool from a healthy donor into the bowel of a patient, has emerged as a startlingly effective means to treat recurrent C. difficile infections. At present, the FDA is proposing to regulate FMT as a biologic drug. However, this proposed classification is both underregulatory and overregulatory. The FDA's primary goal is to ensure that patients have access to safe, effective treatments—and as such they should regulate some aspects of FMT more stringently than they propose to, and others less so. This essay will examine the nature of the regulatory challenges the FDA will face in deciding to regulate FMT as a biologic drug, and will then evaluate available policy alternatives for the FDA to pursue, ultimately concluding that the FDA ought to consider adopting a hybrid regulatory model as it has done in the case of cord blood. PMID:27774199

FDA has the legal authority to adopt a threshold of toxicological concern (TTC) for substances in food at trace levels.

PubMed

Hahn, Martin J

2010-01-01

It now is possible to detect many substances in the parts per trillion and further advances will allow for even lower levels of detection. Many of these substances may always have been present in the food supply, but escaped detection. Others may have been introduced through environmental contamination, changes in food processing, sourcing of ingredients from different manufacturers or countries, and a myriad of other reasons. The adulteration and various safety provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), principles of statutory construction, and case law, provide FDA with the legal authority to adopt the threshold concept. FDA and the courts have long recognized it is possible to establish safe levels of poisonous or deleterious substances found in foods. FDA routinely conducts such an analysis under the general adulteration provisions of the FDCA and has identified safe levels for numerous environmental contaminants found in food. The courts have recognized that through its exercise of enforcement discretion, FDA has the legal authority to establish non-binding defect action levels for contaminants. FDA similarly could implement the Threshold of Toxicological Concern (TTC) through its exercise of enforcement discretion.

Biologics as countermeasures for acute radiation syndrome: where are we now?

PubMed

Singh, Vijay K; Romaine, Patricia L P; Newman, Victoria L

2015-04-01

Despite significant scientific advances toward the development of a safe, nontoxic and effective radiation countermeasure for acute radiation syndrome (ARS) over the past six decades, no drug has been approved by the US FDA. Several biologics are currently under development as radiation countermeasures for ARS, of which three have received FDA Investigational New Drug (IND) status for clinical investigation. Presently, two of these agents, entolimod (CBLB502) and HemaMax (recombinant human IL-12) are progressing with large animal studies and clinical trials. Neupogen (G-CSF, filgrastim) has recently been recommended for approval by an FDA Advisory Committee. Filgrastim, GM-CSF (Leukine, sargramostim), and PEGylated G-CSF (Neulasta) have high potential and well-documented therapeutic effects in countering myelosuppression and may receive full licensing approval by the FDA in the future. The former two biologics are available in the US Strategic National Stockpile (SNS) for use in the event of nuclear or radiological emergency. The Emergency Use Authorization (EAU) application for entolimod may be filed soon with the FDA. Biologics are attractive agents that are progressing along the path for FDA approval, to fill the unmet need for ARS countermeasures.

Optimal tracking and second order sliding power control of the DFIG wind turbine

NASA Astrophysics Data System (ADS)

Abdeddaim, S.; Betka, A.; Charrouf, O.

2017-02-01

In the present paper, an optimal operation of a grid-connected variable speed wind turbine equipped with a Doubly Fed Induction Generator (DFIG) is presented. The proposed cascaded nonlinear controller is designed to perform two main objectives. In the outer loop, a maximum power point tracking (MPPT) algorithm based on fuzzy logic theory is designed to permanently extract the optimal aerodynamic energy, whereas in the inner loop, a second order sliding mode control (2-SM) is applied to achieve smooth regulation of both stator active and reactive powers quantities. The obtained simulation results show a permanent track of the MPP point regardless of the turbine power-speed slope moreover the proposed sliding mode control strategy presents attractive features such as chattering-free, compared to the conventional first order sliding technique (1-SM).

Regulation of prescription drug promotion: direct-to-consumer advertising.

PubMed

Baylor-Henry, M; Drezin, N A

1998-01-01

The US Food and Drug Administration (FDA) is responsible for regulating the information on prescription drugs disseminated by sponsors to health care providers and consumers to ensure that it is truthful and not misleading, and that it presents a fair balance of benefit and risk information. Thus the public health is both protected and promoted by the dissemination of honest, accurate information about regulated products. This paper discusses the regulatory requirements for promotional materials for prescription drugs and the standards used by the FDA to evaluate these materials. It also discusses the agency's views on direct-to-consumer advertising, the enforcement actions that are available to the FDA, the process used by the FDA to determine what action should be taken and when, and what remedies are available.

Anatomy of a recall.

PubMed

Dzanis, David A

2008-08-01

Pet foods on the market that are contaminated or otherwise present a health risk to humans or animals may be subject to a recall under US Food and Drug Administration (FDA) regulations. Legally, all recalls are "voluntary," but there is little incentive for companies to refuse a request by FDA to conduct a recall. While the firm does the bulk of the work, FDA oversees all aspects of a recall to help ensure that violative product is swiftly removed from the market. A recent new federal law will require FDA to improve its abilities to detect outbreaks of pet food-borne illness, respond to a contamination incident, and communicate with industry and the public on the matter of recalls. Veterinarians play a key role in detecting and reporting pet food-borne illness.

Improved robustness and performance of discrete time sliding mode control systems.

PubMed

Chakrabarty, Sohom; Bartoszewicz, Andrzej

2016-11-01

This paper presents a theoretical analysis along with simulations to show that increased robustness can be achieved for discrete time sliding mode control systems by choosing the sliding variable, or the output, to be of relative degree two instead of relative degree one. In other words it successfully reduces the ultimate bound of the sliding variable compared to the ultimate bound for standard discrete time sliding mode control systems. It is also found out that for such a selection of relative degree two output of the discrete time system, the reduced order system during sliding becomes finite time stable in absence of disturbance. With disturbance, it becomes finite time ultimately bounded. Copyright © 2016 ISA. Published by Elsevier Ltd. All rights reserved.

Effect of differing PowerPoint slide design on multiple-choice test scores for assessment of knowledge and retention in a theriogenology course.

PubMed

Root Kustritz, Margaret V

2014-01-01

Third-year veterinary students in a required theriogenology diagnostics course were allowed to self-select attendance at a lecture in either the evening or the next morning. One group was presented with PowerPoint slides in a traditional format (T group), and the other group was presented with PowerPoint slides in the assertion-evidence format (A-E group), which uses a single sentence and a highly relevant graphic on each slide to ensure attention is drawn to the most important points in the presentation. Students took a multiple-choice pre-test, attended lecture, and then completed a take-home assignment. All students then completed an online multiple-choice post-test and, one month later, a different online multiple-choice test to evaluate retention. Groups did not differ on pre-test, assignment, or post-test scores, and both groups showed significant gains from pre-test to post-test and from pre-test to retention test. However, the T group showed significant decline from post-test to retention test, while the A-E group did not. Short-term differences between slide designs were most likely unaffected due to required coursework immediately after lecture, but retention of material was superior with the assertion-evidence slide design.

IMPROVEMENT OF WATER MAIN INSPECTION TECHNOLOGY

EPA Science Inventory

This document is a handout of a slide presentation that addresses improvement of water main inspection technology. The slide presentation addresses the need for improved inspection technology (e.g., 237,000 main breaks/yr); the limits on main break prevention; and, the adverse ...

STUDY OF CHARACTERISTICS CONTRIBUTING TO THE EFFECTIVENESS OF VISUAL DEMONSTRATIONS.

ERIC Educational Resources Information Center

BOGUSLAVSKY, GEORGE W.

SLIDES OF SELECTED TEXTBOOK ILLUSTRATIONS, DRAWN TO HIGHLIGHT THE PERTINENT AREAS OF THE ILLUSTRATION BY MEANS OF SHADING AND ILLUMINATION, WERE USED TO EVALUATE THEIR EFFECTIVENESS OVER SELECTED SLIDES OF CONVENTIONAL ILLUSTRATIONS AND DIAGRAMS IN WHICH ALL DETAILS WERE PROMINENTLY DISPLAYED. WHEN THE CONTROL SLIDES WERE PRESENTED, A TEACHER USED…

Modeling the Sliding/Falling Ladder Paradox

ERIC Educational Resources Information Center

Fox, William P.; Fox, James B.

2003-01-01

Recently we were presented with an interesting twist to the sliding ladder problem viewed in the related rates section of most calculus textbooks. Our problem concerning a sliding ladder that eventually hits the ground. At first, those attempting this problem fell into the calculus trap using only related rates. Previous work for this problem…

An Antique Microscope Slide Brings the Thrill of Discovery into a Contemporary Biology Classroom

ERIC Educational Resources Information Center

Reiser, Frank

2012-01-01

The discovery of a Victorian-era microscope slide titled "Grouped Flower Seeds" began an investigation into the scientific and historical background of the antique slide to develop its usefulness as a multidisciplinary tool for PowerPoint presentations usable in contemporary biology classrooms, particularly large-enrollment sections. The resultant…

Revising the Redundancy Principle in Multimedia Learning

ERIC Educational Resources Information Center

Mayer, Richard E.; Johnson, Cheryl I.

2008-01-01

College students viewed a short multimedia PowerPoint presentation consisting of 16 narrated slides explaining lightning formation (Experiment 1) or 8 narrated slides explaining how a car's braking system works (Experiment 2). Each slide appeared for approximately 8-10 s and contained a diagram along with 1-2 sentences of narration spoken in a…

Research of the Quality of Quarry Dumpers Engine Crankshafts Sliding Bearings of Various Manufacturers

NASA Astrophysics Data System (ADS)

Korotkov, Alexander; Korotkova, Lidiya; Vidin, Denis

2017-11-01

Sliding bearings are an important part of many large and critical components. They are widely used in power equipment, high-capacity pumps, compressors, electric motors and internal combustion engines (ICE). As a rule, sliding bearings include an antifriction bushing, part of the shaft surface (bearing journal), and a layer of oil between them. These are complex and critical parts in which there may occur dangerous defects, and which directly affect the durability, accuracy and reliability of the entire unit. To ensure high reliability of the equipment with sliding bearings applied in complex equipment, it is necessary to provide the quality control and sufficient level of monitoring of the technical condition, as well as diagnosis of emerging defects. This paper presents a comparative analysis of the internal combustion engines sliding bearings quality of various manufacturing companies. It gives operational properties of bearings depending on the compositional composition. The results of chemical analysis of the base, the cover and intermediate layers of the ICE liners are presented here. We have also made recommendations to increase the operational performance of sliding bearings.

An Adaptive Supervisory Sliding Fuzzy Cerebellar Model Articulation Controller for Sensorless Vector-Controlled Induction Motor Drive Systems

PubMed Central

Wang, Shun-Yuan; Tseng, Chwan-Lu; Lin, Shou-Chuang; Chiu, Chun-Jung; Chou, Jen-Hsiang

2015-01-01

This paper presents the implementation of an adaptive supervisory sliding fuzzy cerebellar model articulation controller (FCMAC) in the speed sensorless vector control of an induction motor (IM) drive system. The proposed adaptive supervisory sliding FCMAC comprised a supervisory controller, integral sliding surface, and an adaptive FCMAC. The integral sliding surface was employed to eliminate steady-state errors and enhance the responsiveness of the system. The adaptive FCMAC incorporated an FCMAC with a compensating controller to perform a desired control action. The proposed controller was derived using the Lyapunov approach, which guarantees learning-error convergence. The implementation of three intelligent control schemes—the adaptive supervisory sliding FCMAC, adaptive sliding FCMAC, and adaptive sliding CMAC—were experimentally investigated under various conditions in a realistic sensorless vector-controlled IM drive system. The root mean square error (RMSE) was used as a performance index to evaluate the experimental results of each control scheme. The analysis results indicated that the proposed adaptive supervisory sliding FCMAC substantially improved the system performance compared with the other control schemes. PMID:25815450

An adaptive supervisory sliding fuzzy cerebellar model articulation controller for sensorless vector-controlled induction motor drive systems.

PubMed

Wang, Shun-Yuan; Tseng, Chwan-Lu; Lin, Shou-Chuang; Chiu, Chun-Jung; Chou, Jen-Hsiang

2015-03-25

This paper presents the implementation of an adaptive supervisory sliding fuzzy cerebellar model articulation controller (FCMAC) in the speed sensorless vector control of an induction motor (IM) drive system. The proposed adaptive supervisory sliding FCMAC comprised a supervisory controller, integral sliding surface, and an adaptive FCMAC. The integral sliding surface was employed to eliminate steady-state errors and enhance the responsiveness of the system. The adaptive FCMAC incorporated an FCMAC with a compensating controller to perform a desired control action. The proposed controller was derived using the Lyapunov approach, which guarantees learning-error convergence. The implementation of three intelligent control schemes--the adaptive supervisory sliding FCMAC, adaptive sliding FCMAC, and adaptive sliding CMAC--were experimentally investigated under various conditions in a realistic sensorless vector-controlled IM drive system. The root mean square error (RMSE) was used as a performance index to evaluate the experimental results of each control scheme. The analysis results indicated that the proposed adaptive supervisory sliding FCMAC substantially improved the system performance compared with the other control schemes.

Preliminary study of head-up assessment techniques. 1: Viewing duration of instrument panel and HUD symbology using a recall methodology

NASA Technical Reports Server (NTRS)

Haines, R. F.

1978-01-01

Eight commercial pilots were shown 50 colored, high fidelity slides of a standard instrument panel (IP) with the needle positions of each instrument varying from slide to slide and then 50 slides of a head-up display (HUD) symbology format which contained an equivalent amount of flight-related information as the instrument panel slides. All stimuli were presented under controlled, static viewing conditions that allowed the measurement of the speed and accuracy with which one randomly selected flight parameter on each slide could be read. The subject did not know which parameter would be requested and, therefore, had to remember the total set of information in order to answer the question correctly. The results showed that from 6.6 - 8.7 sec total viewing time was required to correctly extract altitude, airspeed, heading, VSI, or ADI from the IP slides and from 6.1 to 7.4 sec for the HUD slides.

77 FR 55845 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-11

... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Anti... indication of treatment of inhalational anthrax. FDA intends to make background material available to the... of the general nature of the evidence or arguments they wish to present, the names and addresses of...

Robust sliding mode control applied to double Inverted pendulum system

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mahjoub, Sonia; Derbel, Nabil; Mnif, Faical

A three hierarchical sliding mode control is presented for a class of an underactuated system which can overcome the mismatched perturbations. The considered underactuated system is a double inverted pendulum (DIP), can be modeled by three subsystems. Such structure allows the construction of several designs of hierarchies for the controller. For all hierarchical designs, the asymptotic stability of every layer sliding mode surface and the sliding mode surface of subsystems are proved theoretically by Barbalat's lemma. Simulation results show the validity of these methods.

Robustness and Actuator Bandwidth of MRP-Based Sliding Mode Control for Spacecraft Attitude Control Problems

NASA Astrophysics Data System (ADS)

Keum, Jung-Hoon; Ra, Sung-Woong

2009-12-01

Nonlinear sliding surface design in variable structure systems for spacecraft attitude control problems is studied. A robustness analysis is performed for regular form of system, and calculation of actuator bandwidth is presented by reviewing sliding surface dynamics. To achieve non-singular attitude description and minimal parameterization, spacecraft attitude control problems are considered based on modified Rodrigues parameters (MRP). It is shown that the derived controller ensures the sliding motion in pre-determined region irrespective of unmodeled effects and disturbances.

Hands-on Science. Exploring Magnification.

ERIC Educational Resources Information Center

Kepler, Lynne

1993-01-01

Presents hands-on science activities using inexpensive, hand-held microscopes and slides made from simple, readily available materials. The article describes how to introduce students to microscopes and presents directions for using the microscopes and making slides. A student page investigates fingerprints with microscopes. (SM)

A new optimal sliding mode controller design using scalar sign function.

PubMed

Singla, Mithun; Shieh, Leang-San; Song, Gangbing; Xie, Linbo; Zhang, Yongpeng

2014-03-01

This paper presents a new optimal sliding mode controller using the scalar sign function method. A smooth, continuous-time scalar sign function is used to replace the discontinuous switching function in the design of a sliding mode controller. The proposed sliding mode controller is designed using an optimal Linear Quadratic Regulator (LQR) approach. The sliding surface of the system is designed using stable eigenvectors and the scalar sign function. Controller simulations are compared with another existing optimal sliding mode controller. To test the effectiveness of the proposed controller, the controller is implemented on an aluminum beam with piezoceramic sensor and actuator for vibration control. This paper includes the control design and stability analysis of the new optimal sliding mode controller, followed by simulation and experimental results. The simulation and experimental results show that the proposed approach is very effective. © 2013 ISA. Published by Elsevier Ltd. All rights reserved.

Instructing the Academic Library User: Historical Background and Utilization of Audiovisual Presentations.

ERIC Educational Resources Information Center

Whitmore, Marilyn P.

A brief sketch of the trends in bibliographic instruction from the 30's through the 70's introduces this review of the literature on applications of instructional media in programs for academic library users. Formats discussed include television, programmed instruction, multimedia presentations, and slide/tape presentations. The slide/tape program…

Design of sliding-mode observer for a class of uncertain neutral stochastic systems

NASA Astrophysics Data System (ADS)

Liu, Zhen; Zhao, Lin; Zhu, Quanmin; Gao, Cunchen

2017-05-01

The problem of robust ? control for a class of uncertain neutral stochastic systems (NSS) is investigated by utilising the sliding-mode observer (SMO) technique. This paper presents a novel observer and integral-type sliding-surface design, based on which a new sufficient condition guaranteeing the resultant sliding-mode dynamics (SMDs) to be mean-square exponentially stable with a prescribed level of ? performance is derived. Then, an adaptive reaching motion controller is synthesised to lead the system to the predesigned sliding surface in finite-time almost surely. Finally, two illustrative examples are exhibited to verify the validity and superiority of the developed scheme.

Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines.

PubMed

Klara, Kristina; Kim, Jeanie; Ross, Joseph S

2018-05-01

Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions. Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.

General Mission Analysis Tool (GMAT)

NASA Technical Reports Server (NTRS)

Hughes, Steven P. (Compiler)

2016-01-01

This is a software tutorial and presentation demonstrating the application of the General Mission Analysis Tool (GMAT) to the critical design phase of NASA missions. The demonstration discusses GMAT basics, then presents a detailed example of GMAT application to the Transiting Exoplanet Survey Satellite (TESS) mission. Other examples include OSIRIS-Rex. This talk is a combination of existing presentations; a GMAT basics and overview, and technical presentations from the TESS and OSIRIS-REx projects on their application of GMAT to critical mission design. The GMAT basics slides are taken from the open source training material. The OSIRIS-REx slides are from a previous conference presentation. The TESS slides are a streamlined version of the CDR package provided by the project with SBU and ITAR data removed by the TESS project.

Slide Presentations as Speech Suppressors: When and Why Learners Miss Oral Information

ERIC Educational Resources Information Center

Wecker, Christof

2012-01-01

The objective of this study was to test whether information presented on slides during presentations is retained at the expense of information presented only orally, and to investigate part of the conditions under which this effect occurs, and how it can be avoided. Such an effect could be expected and explained either as a kind of redundancy…

Wishes and Riddles: Symbolic Imagery in Chinese Art.

ERIC Educational Resources Information Center

Asian Art Museum of San Francisco, CA.

This teacher's packet accompanies a slide presentation on the wishes and riddles found in myths and rebuses in Chinese art. The packet contains: (1) an introductory essay describing symbolism used in the art of various dynasties of China; (2) a slide list describing the art depicted on each slide with time period and dimensions of the piece; (3) a…

Music for the Eyes: Slide/Tape and Video Techniques.

ERIC Educational Resources Information Center

Pembrook, Randall G.

1983-01-01

Slide/tape and videotape presentations can be used in music education to project music scores, document music tours and special programs, and present self-contained units for student mastery of specific skills. Materials needed, cost, and procedures for teacher-developed materials are outlined. (KC)

Analysis of Transcriptomic Dose Response Data in the ...

EPA Pesticide Factsheets

Slide presentation at the HESI-HEALTH Canada-McGill Workshop on Transcriptomic Dose Response Data in the Context of Chemical Risk Assessment Slide presentation at the HESI-HEALTH Canada-McGill Workshop on Transcriptomic Dose Response Data in the Context of Chemical Risk Assessment

Maximizing the Effectiveness of Electronic Presentations.

ERIC Educational Resources Information Center

Quible, Zane K.

2002-01-01

Notes that the manner in which the author was using the incorporation of electronic slides into his lectures allowed students to become disengaged from the learning process. Presents strategies to combat disengagement and strategies to supplement textbook slides. Concludes that student disengagement can be counteracted with limited expenditure of…

A technigue exploitation about anti-slide tire polyploid on ice-snow road in winter

NASA Astrophysics Data System (ADS)

Xiaojie, Qi; Qiang, Wang; Zhao, Yang; Yunlong, Wang; Guotian, Wang; Degang, Lv

2017-04-01

Present studies focus on improving anti-slide property of tyes on ice-snow road by changing material modification of tyre tread and designing groove. However, the basic reason causing starting slide, long braking distance, turning slide slip and so on of tyres used in winter is that tyre tread materials are unitary and homogenous rubber composite which can’t coordinate driving demands of tyres in winter under muti-work condition, and can’t exert their best property when starting, braking and sliding slip. In order to improve comprehensive anti-slide property of tyres, this paper discusses about changing structure, shape and distribution proportion among haploid materials of tyre tread rubber. Polyploid bubber tyre tread technique based on artificial neural network which is in favor of starting, braking and anti-slide slip is optimized and combined. Friction feature and anti-slide mechanism on ice-snow road of polyploid rubber tyre tread are studied using testing technique of low-temperature cabin and computer simulation. A set high anti-slide theories and realizing method systems of polyploid rubber composite formed from basic theory, models and technique method are developped which will be applied into solving anti-slide problem of winter tyres, provide theory instruction for studies on high anti-slide winter tyres, and promote development of application and usage safety of winter tyres.

Triggering mechanism and tsunamogenic potential of the Cape Fear Slide complex, U.S. Atlantic margin

USGS Publications Warehouse

Hornbach, Matthew J.; Lavier, Luc L.; Ruppel, Carolyn D.

2007-01-01

Analysis of new multibeam bathymetry data and seismic Chirp data acquired over the Cape Fear Slide complex on the U.S. Atlantic margin suggests that at least 5 major submarine slides have likely occurred there within the past 30,000 years, indicating that repetitive, large-scale mass wasting and associated tsunamis may be more common in this area than previously believed. Gas hydrate deposits and associated free gas as well as salt tectonics have been implicated in previous studies as triggers for the major Cape Fear slide events. Analysis of the interaction of the gas hydrate phase boundary and the various generations of slides indicates that only the most landward slide likely intersected the phase boundary and inferred high gas pressures below it. For much of the region, we believe that displacement along a newly recognized normal fault led to upward migration of salt, oversteepening of slopes, and repeated slope failures. Using new constraints on slide morphology, we develop the first tsunami model for the Cape Fear Slide complex. Our results indicate that if the most seaward Cape Fear slide event occurred today, it could produce waves in excess of 2 m at the present-day 100 m bathymetric contour.

Opportunity for information search and the effect of false heart rate feedback.

PubMed

Barefoot, John C; Straub, Ronald B

2005-01-01

The role of information search in the attribution of physiological states was investigated by manipulating the subject's opportunity for information search following the presentation of false information about his heart-rate reactions to photographs of female nudes. Consistent with the self-persuasion hypothesis proposed by Valins, the rated attractiveness of the slides was not affected by the false heart-rate feedback for those subjects who were prevented from visually searching the slides. Those subjects who had ample opportunity to view the slides rated those slides accompanied by false information of a heart-rate change as more attractive than those slides which were not paired with a change in heart rate.

FDA regulation of adult stem cell therapies as used in sports medicine.

PubMed

Chirba, Mary Ann; Sweetapple, Berkley; Hannon, Charles P; Anderson, John A

2015-02-01

In sports medicine, adult stem cells are the subject of great interest. Several uses of stem cells are under investigation including cartilage repair, meniscal regeneration, anterior cruciate ligament reconstruction, and tendinopathy. Extensive clinical and basic science research is warranted as stem cell therapies become increasingly common in clinical practice. In the United States, the Food and Drug Administration (FDA) is responsible for regulating the use of stem cells through its "Human Cells, Tissues, and Cellular and Tissue-Based Products" regulations. This report provides a brief overview of FDA regulation of adult stem cells. Several common clinical case scenarios are then presented that highlight how stem cells are currently being used in sports medicine and how current FDA regulations are likely to affect the physicians who use them. In the process, it explains how a variety of factors in sourcing and handling these cells, particularly the extent of cell manipulation, will affect what a physician can and cannot do without first obtaining the FDA's express approval. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Morphological study on the prediction of the site of surface slides

Treesearch

Hiromasa Hiura

1991-01-01

The annual continual occurrence of surface slides in the basin was estimated by modifying the estimation formula of Yoshimatsu. The Weibull Distribution Function revealed to be usefull for presenting the state and the transition of surface slides in the basin. Three parameters of the Weibull Function are recognized to be the linear function of the area ratio a/A. The...

Stick-slip nanofriction in cold-ion traps

NASA Astrophysics Data System (ADS)

Mandelli, Davide; Vanossi, Andrea; Tosatti, Erio

2013-03-01

Trapped cold ions are known to form linear or planar zigzag chains, helices or clusters depending on trapping conditions. They may be forced to slide over a laser induced corrugated potential, a mimick of sliding friction. We present MD simulations of an incommensurate 101 ions chain sliding subject to an external electric field. As expected with increasing corrugation, we observe the transition from a smooth-sliding, highly lubric regime to a strongly dissipative stick-slip regime. Owing to inhomogeneity the dynamics shows features reminiscent of macroscopic frictional behaviors. While the chain extremities are pinned, the incommensurate central part is initially free to slide. The onset of global sliding is preceded by precursor events consisting of partial slips of chain portions further from the center. We also look for frictional anomalies expected for the chain sliding across the linear-zigzag structural phase transition. Although the chain is too short for a proper critical behavior, the sliding friction displays a frank rise near the transition, due to opening of a new dissipative channel via excitations of transverse modes. Research partly sponsored by Sinergia Project CRSII2 136287/1.

Second-Order Consensus in Multiagent Systems via Distributed Sliding Mode Control.

PubMed

Yu, Wenwu; Wang, He; Cheng, Fei; Yu, Xinghuo; Wen, Guanghui

2016-11-22

In this paper, the new decoupled distributed sliding-mode control (DSMC) is first proposed for second-order consensus in multiagent systems, which finally solves the fundamental unknown problem for sliding-mode control (SMC) design of coupled networked systems. A distributed full-order sliding-mode surface is designed based on the homogeneity with dilation for reaching second-order consensus in multiagent systems, under which the sliding-mode states are decoupled. Then, the SMC is applied to the decoupled sliding-mode states to reach their origin in finite time, which is the sliding-mode surface. The states of agents can first reach the designed sliding-mode surface in finite time and then move to the second-order consensus state along the surface in finite time as well. The DSMC designed in this paper can eliminate the influence of singularity problems and weaken the influence of chattering, which is still very difficult in the SMC systems. In addition, DSMC proposes a general decoupling framework for designing SMC in networked multiagent systems. Simulations are presented to verify the theoretical results in this paper.

Second-order sliding mode control with experimental application.

PubMed

Eker, Ilyas

2010-07-01

In this article, a second-order sliding mode control (2-SMC) is proposed for second-order uncertain plants using equivalent control approach to improve the performance of control systems. A Proportional + Integral + Derivative (PID) sliding surface is used for the sliding mode. The sliding mode control law is derived using direct Lyapunov stability approach and asymptotic stability is proved theoretically. The performance of the closed-loop system is analysed through an experimental application to an electromechanical plant to show the feasibility and effectiveness of the proposed second-order sliding mode control and factors involved in the design. The second-order plant parameters are experimentally determined using input-output measured data. The results of the experimental application are presented to make a quantitative comparison with the traditional (first-order) sliding mode control (SMC) and PID control. It is demonstrated that the proposed 2-SMC system improves the performance of the closed-loop system with better tracking specifications in the case of external disturbances, better behavior of the output and faster convergence of the sliding surface while maintaining the stability. 2010 ISA. Published by Elsevier Ltd. All rights reserved.

Humboldt slide - A large shear-dominated retrogressive slope failure

USGS Publications Warehouse

Gardner, J.V.; Prior, D.B.; Field, M.E.

1999-01-01

Humboldt Slide is a large, complex slide zone located on the northern California continental margin. Its three-dimensional architecture has been imaged by a combination of multibeam bathymetry, Huntec Deep-Tow seismic profiling, and sidescan sonar. The slide is interpreted to be Late Pleistocene to early Holocene in age and was caused by a combination of factors. The area of the slide is a local depocenter with high accumulation rates of organic-rich sediment; there has been local steepening of slopes by tectonic uplifts; and the entire area is one of high seismicity. Overall, the failure occurred by retrogressive, shear-dominated, minimum movement apparently as a sequence of events. Failure initially occurred by subsidence extension at the middle of the feature, followed by upslope retrogressive failure and downslope compression, and finally by translational sliding at the top of the slide. Degassing, as evidenced by abundant pockmarks, may have inhibited downslope translation. The slide may still be active, as suggested by offsets in Holocene hemipelagic sediment draped over some of the shear surfaces. Crown cracks occur above the present head of the failure and may represent the next generation of failure.

Terminal Sliding Mode Tracking Controller Design for Automatic Guided Vehicle

NASA Astrophysics Data System (ADS)

Chen, Hongbin

2018-03-01

Based on sliding mode variable structure control theory, the path tracking problem of automatic guided vehicle is studied, proposed a controller design method based on the terminal sliding mode. First of all, through analyzing the characteristics of the automatic guided vehicle movement, the kinematics model is presented. Then to improve the traditional expression of terminal sliding mode, design a nonlinear sliding mode which the convergence speed is faster than the former, verified by theoretical analysis, the design of sliding mode is steady and fast convergence in the limited time. Finally combining Lyapunov method to design the tracking control law of automatic guided vehicle, the controller can make the automatic guided vehicle track the desired trajectory in the global sense as well as in finite time. The simulation results verify the correctness and effectiveness of the control law.

Time-varying sliding-coefficient-based decoupled terminal sliding-mode control for a class of fourth-order systems.

PubMed

Bayramoglu, Husnu; Komurcugil, Hasan

2014-07-01

A time-varying sliding-coefficient-based decoupled terminal sliding mode control strategy is presented for a class of fourth-order systems. First, the fourth-order system is decoupled into two second-order subsystems. The sliding surface of each subsystem was designed by utilizing time-varying coefficients. Then, the control target of one subsystem to another subsystem was embedded. Thereafter, a terminal sliding mode control method was utilized to make both subsystems converge to their equilibrium points in finite time. The simulation results on the inverted pendulum system demonstrate that the proposed method exhibits a considerable improvement in terms of a faster dynamic response and lower IAE and ITAE values as compared with the existing decoupled control methods. Copyright © 2014 ISA. Published by Elsevier Ltd. All rights reserved.

Predictive Toxicology: Current Status and Future Outlook (EBI ...

EPA Pesticide Factsheets

Slide presentation at the EBI-EMBL Industry Programme Workshop on Predictive Toxicology and the currently status of Computational Toxicology activities at the US EPA. Slide presentation at the EBI-EMBL Industry Programme Workshop on Predictive Toxicology and the currently status of Computational Toxicology activities at the US EPA.

Analysis of Asymmetry by a Slide-Vector.

ERIC Educational Resources Information Center

Zielman, Berrie; Heiser, Willem J.

1993-01-01

An algorithm based on the majorization theory of J. de Leeuw and W. J. Heiser is presented for fitting the slide-vector model. It views the model as a constrained version of the unfolding model. A three-way variant is proposed, and two examples from market structure analysis are presented. (SLD)

ARSENIC BIOAVAILABILITY ASSOCIATED WITH THE PRESENCE OF CCA-TREATED WOOD PRODUCTS

EPA Science Inventory

This is an invited paper/slide presentation to be presented by Dr. Karen Bradham at the 8th International Conference on the Biogeochemistry of Trace Elements, Adelaide, Australia, April 3 - 7, 2005. The PowerPoint slides describe the study design of projects currently being perf...

Transitioning from AOP to IATA - Exploiting mechanistic ...

EPA Pesticide Factsheets

Slide presentation at satellite meeting of the QSAR2016 Meeting on How to Transition from AOP to IATA-Exploiting mechanistic insight for practical decision making. . Slide presentation at satellite meeting of the QSAR2016 Meeting on How to Transition from AOP to IATA-Exploiting mechanistic insight for practical decision making. .

The Environmental Obligations of Experiential Education: A Slide Presentation [Script].

ERIC Educational Resources Information Center

Nadeau, Tina

The slide presentation script is intended to familiarize environmental educators with the "Whole Life Factor," an educational tool developed by the National Audubon Society Expedition Institute. The script first explores cultural images of nature and prejudice against nature. The theory that civilization perceives the planet as divided…

Dynamical phenomena in fast sliding nanotube models

NASA Astrophysics Data System (ADS)

Zhang, X. H.; Santoro, G. E.; Tartaglino, U.; Tosatti, E.

2013-03-01

The experimentally known fact that coaxial carbon nanotubes can be forced to slide one inside the other stimulated in the past much detailed modelling of the dynamical sliding process. Molecular dynamics simulations of sliding coaxial nanotubes showed the existence of strong frictional peaks when, at large speed, one tube excites the other with a 'washboard' frequency that happens to resonate with some intrinsic vibration frequency. At some of these special speeds we discover a striking example of dynamical symmetry breaking taking place at the nanoscale. Even when both nanotubes are perfectly left-right symmetric and nonchiral, precisely in correspondence with the large peaks of sliding friction occurring at a series of critical sliding velocities, a nonzero angular momentum spontaneously appears. A detailed analysis shows that this internal angular momentum is of phonon origin, in particular arising from preferential excitation of a right polarized (or, with equal probability, of a left polarized) outer-tube 'pseudorotation' mode, thus spontaneously breaking their exact twofold right-left degeneracy. We present and discuss a detailed analysis of nonlinear continuum equations governing this phenomenon, showing the close similarity of this phenomenon with the well-known rotational instability of a forced string, which takes place under sufficiently strong periodic forcing of the string. We also point out new elements appearing in the present problem which are 'nano', in particular the involvement of Umklapp processes and the role of sliding nanofriction.

Overcoming obstacles to repurposing for neurodegenerative disease

PubMed Central

Shineman, Diana W; Alam, John; Anderson, Margaret; Black, Sandra E; Carman, Aaron J; Cummings, Jeffrey L; Dacks, Penny A; Dudley, Joel T; Frail, Donald E; Green, Allan; Lane, Rachel F; Lappin, Debra; Simuni, Tanya; Stefanacci, Richard G; Sherer, Todd; Fillit, Howard M

2014-01-01

Repurposing Food and Drug Administration (FDA)-approved drugs for a new indication may offer an accelerated pathway for new treatments to patients but is also fraught with significant commercial, regulatory, and reimbursement challenges. The Alzheimer’s Drug Discovery Foundation (ADDF) and the Michael J. Fox Foundation for Parkinson’s Research (MJFF) convened an advisory panel in October 2013 to understand stakeholder perspectives related to repurposing FDA-approved drugs for neurodegenerative diseases. Here, we present opportunities on how philanthropy, industry, and government can begin to address these challenges, promote policy changes, and develop targeted funding strategies to accelerate the potential of FDA-approved repurposed drugs. PMID:25356422

Four Key Keys to Powerful Presentations in PowerPoint: Take Your Presentations to the Next Level

ERIC Educational Resources Information Center

Howell, Dusti D.

2008-01-01

If a person is on a presentation and he/she does not know how to go back to a previous PowerPoint slide, his/her credibility will be clouded and the audience will become frustrated. More sophisticated presenters use handheld remotes to control the basic navigation of slides. Even in this case, keyboard shortcuts can be an added benefit. For those…

Overview of Selection Process for Most Influential Paper of the 1970's

NASA Technical Reports Server (NTRS)

Hayes, Peggy S.; Moser, Kelsey M.

2011-01-01

Slides are for a presentation at the AIAA AFM conference invited session titled, 'AFM Most Influential Papers of the 1970's'. The slides describe the selection process used by the members of the technical committee to select the finalists and winning paper. The slides refer to technical papers published in the past, but have no technical data contained within them.

Semantic focusing allows fully automated single-layer slide scanning of cervical cytology slides.

PubMed

Lahrmann, Bernd; Valous, Nektarios A; Eisenmann, Urs; Wentzensen, Nicolas; Grabe, Niels

2013-01-01

Liquid-based cytology (LBC) in conjunction with Whole-Slide Imaging (WSI) enables the objective and sensitive and quantitative evaluation of biomarkers in cytology. However, the complex three-dimensional distribution of cells on LBC slides requires manual focusing, long scanning-times, and multi-layer scanning. Here, we present a solution that overcomes these limitations in two steps: first, we make sure that focus points are only set on cells. Secondly, we check the total slide focus quality. From a first analysis we detected that superficial dust can be separated from the cell layer (thin layer of cells on the glass slide) itself. Then we analyzed 2,295 individual focus points from 51 LBC slides stained for p16 and Ki67. Using the number of edges in a focus point image, specific color values and size-inclusion filters, focus points detecting cells could be distinguished from focus points on artifacts (accuracy 98.6%). Sharpness as total focus quality of a virtual LBC slide is computed from 5 sharpness features. We trained a multi-parameter SVM classifier on 1,600 images. On an independent validation set of 3,232 cell images we achieved an accuracy of 94.8% for classifying images as focused. Our results show that single-layer scanning of LBC slides is possible and how it can be achieved. We assembled focus point analysis and sharpness classification into a fully automatic, iterative workflow, free of user intervention, which performs repetitive slide scanning as necessary. On 400 LBC slides we achieved a scanning-time of 13.9±10.1 min with 29.1±15.5 focus points. In summary, the integration of semantic focus information into whole-slide imaging allows automatic high-quality imaging of LBC slides and subsequent biomarker analysis.

Comparison of four DNA extraction methods for the detection of Mycobacterium leprae from Ziehl-Neelsen-stained microscopic slides.

PubMed

Ruiz-Fuentes, Jenny Laura; Díaz, Alexis; Entenza, Anayma Elena; Frión, Yahima; Suárez, Odelaisy; Torres, Pedro; de Armas, Yaxsier; Acosta, Lucrecia

2015-12-01

The diagnosis of leprosy has been a challenge due to the low sensibility of the conventional methods and the impossibility of culturing the causative organism. In this study, four methods for Mycobacterium leprae nucleic-acid extraction from Ziehl-Neelsen-stained slides (ZNS slides) were compared: Phenol/chloroform, Chelex 100 resin, and two commercial kits (Wizard Genomic DNA Purification Kit and QIAamp DNA Mini Kit). DNA was extracted from four groups of slides: a high-codification-slide group (bacteriological index [BI]⩾4), a low-codification-slide group (BI=1), a negative-slide group (BI=0), and a negative-control-slide group (BI=0). Quality DNA was evidenced by the amplification of specific repetitive element present in M. leprae genomic DNA (RLEP) using a nested polymerase chain reaction. This is the first report comparing four different extraction methods for obtaining M. leprae DNA from ZNS slides in Cuban patients, and applied in molecular diagnosis. Good-quality DNA and positive amplification were detected in the high-codification-slide group with the four methods, while from the low-codification-slide group only the QIAGEN and phenol-chloroform methods obtained amplification of M. leprae. In the negative-slide group, only the QIAGEN method was able to obtain DNA with sufficient quality for positive amplification of the RLEP region. No amplification was observed in the negative-control-slide group by any method. Patients with ZNS negative slides can still transmit the infection, and molecular methods can help identify and treat them, interrupting the chain of transmission and preventing the onset of disabilities. The ZNS slides can be sent easily to reference laboratories for later molecular analysis that can be useful not only to improve the diagnosis, but also for the application of other molecular techniques. Copyright © 2015 Asian-African Society for Mycobacteriology. Published by Elsevier Ltd. All rights reserved.

Optimal Guaranteed Cost Sliding Mode Control for Constrained-Input Nonlinear Systems With Matched and Unmatched Disturbances.

PubMed

Zhang, Huaguang; Qu, Qiuxia; Xiao, Geyang; Cui, Yang

2018-06-01

Based on integral sliding mode and approximate dynamic programming (ADP) theory, a novel optimal guaranteed cost sliding mode control is designed for constrained-input nonlinear systems with matched and unmatched disturbances. When the system moves on the sliding surface, the optimal guaranteed cost control problem of sliding mode dynamics is transformed into the optimal control problem of a reformulated auxiliary system with a modified cost function. The ADP algorithm based on single critic neural network (NN) is applied to obtain the approximate optimal control law for the auxiliary system. Lyapunov techniques are used to demonstrate the convergence of the NN weight errors. In addition, the derived approximate optimal control is verified to guarantee the sliding mode dynamics system to be stable in the sense of uniform ultimate boundedness. Some simulation results are presented to verify the feasibility of the proposed control scheme.

Static and dynamic friction in sliding colloidal monolayers

PubMed Central

Vanossi, Andrea; Manini, Nicola; Tosatti, Erio

2012-01-01

In a pioneer experiment, Bohlein et al. realized the controlled sliding of two-dimensional colloidal crystals over laser-generated periodic or quasi-periodic potentials. Here we present realistic simulations and arguments that besides reproducing the main experimentally observed features give a first theoretical demonstration of the potential impact of colloid sliding in nanotribology. The free motion of solitons and antisolitons in the sliding of hard incommensurate crystals is contrasted with the soliton–antisoliton pair nucleation at the large static friction threshold Fs when the two lattices are commensurate and pinned. The frictional work directly extracted from particles’ velocities can be analyzed as a function of classic tribological parameters, including speed, spacing, and amplitude of the periodic potential (representing, respectively, the mismatch of the sliding interface and the corrugation, or “load”). These and other features suggestive of further experiments and insights promote colloid sliding to a unique friction study instrument. PMID:23019582

Child Care Funding: The Story since 1996, the Challenges in Reauthorization.

ERIC Educational Resources Information Center

Greenberg, Mark; Mezey, Jennifer; Schumacher, Rachel

This document is comprised of presentation slides for overhead projection summarizing federal funding for child care since the 1996 changes in welfare and child care laws, and the status of reauthorization. The first slide provides a presentation overview; the remaining sheets cover the following: (1) two main sources of federal funds for…

Planning a Financial Aid Awareness Program.

ERIC Educational Resources Information Center

Department of Education, Washington, DC.

This booklet is intended to be used with a set of slides as part of presentations to students. Each page usually includes an illustration of the accompanying slide, the basic information to be communicated, background notes and answers to common questions as appropriate. The presentation first considers why a student should go to college or career…

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lei, Hongzhuan; Lu, Zhiming; Vesselinov, Velimir Valentinov

These are slides from a presentation on identifying heterogeneities in subsurface environment using the level set method. The slides start with the motivation, then explain Level Set Method (LSM), the algorithms, some examples are given, and finally future work is explained.

Smith predictor based-sliding mode controller for integrating processes with elevated deadtime.

PubMed

Camacho, Oscar; De la Cruz, Francisco

2004-04-01

An approach to control integrating processes with elevated deadtime using a Smith predictor sliding mode controller is presented. A PID sliding surface and an integrating first-order plus deadtime model have been used to synthesize the controller. Since the performance of existing controllers with a Smith predictor decrease in the presence of modeling errors, this paper presents a simple approach to combining the Smith predictor with the sliding mode concept, which is a proven, simple, and robust procedure. The proposed scheme has a set of tuning equations as a function of the characteristic parameters of the model. For implementation of our proposed approach, computer based industrial controllers that execute PID algorithms can be used. The performance and robustness of the proposed controller are compared with the Matausek-Micić scheme for linear systems using simulations.

Hillslope Evolution by Bedrock Landslides

PubMed

Densmore; Anderson; McAdoo; Ellis

1997-01-17

Bedrock landsliding is a dominant geomorphic process in a number of high-relief landscapes, yet is neglected in landscape evolution models. A physical model of sliding in beans is presented, in which incremental lowering of one wall simulates baselevel fall and generates slides. Frequent small slides produce irregular hillslopes, on which steep toes and head scarps persist until being cleared by infrequent large slides. These steep segments are observed on hillslopes in high-relief landscapes and have been interpreted as evidence for increases in tectonic or climatic process rates. In certain cases, they may instead reflect normal hillslope evolution by landsliding.

US FDA perspective on regulatory issues affecting circulatory assist devices.

PubMed

Sapirstein, Wolf; Chen, Eric; Swain, Julie; Zuckerman, Bram

2006-11-01

There has been a rapid development in mechanical circulatory support systems in the decade since the US FDA first approved a mechanical device to provide the circulatory support lacking from a failing heart. Devices are presently approved for marketing by the FDA to replace a failing ventricle, the Ventricular Assist Device or the entire heart, Total Artificial Heart. Contemporaneous with, and permitted by, improvement in technology and design, devices have evolved from units located extracorporeally to paracorporeal systems and totally implanted devices. Clinical studies have demonstrated a parallel improvement in the homeostatic adequacy of the circulatory support provided. Thus, while the circulatory support was initially tolerated for short periods to permit recovery of cardiac function, this technology eventually provided effective circulatory support for increasing periods that permitted the FDA to approve devices for bridging patients in end-stage cardiac failure awaiting transplant and eventually a device for destination therapy where patients in end-stage heart failure are not cardiac transplant candidates. The approved devices have relied on displacement pumps that mimic the pulsatility of the physiological system. Accelerated development of more compact devices that rely on alternative pump mechanisms have challenged both the FDA and device manufacturers to assure that the regulatory requirements for safety and effectiveness are met for use of mechanical circulatory support systems in expanded target populations. An FDA regulatory perspective is reviewed of what can be a potentially critical healthcare issue.

XPS analysis of 440C steel surfaces lubricated with perfluoropolyethers under sliding conditions in high vacuum

NASA Technical Reports Server (NTRS)

Herrera-Fierro, Pilar; Masuko, Masabumi; Jones, William R., Jr.; Pepper, Stephen V.

1994-01-01

This work presents the results of the X-Ray Photoelectron Spectroscopy (XPS) analysis of AISI 440C ball surfaces lubricated with perfluoropolyether (PFPE) oils after friction experiments under sliding conditions at high load in air and vacuum environments. The PFPE lubricants tested were Demnum S100, Fomblin Z-25, and Krytox 143AB. It was found that all the PFPE lubricants were degraded by sliding contact causing the formation of inorganic fluorides on the metallic surfaces and a layer of organic decomposition products. KRYTOX 143AB was the least reactive of the three lubricants tested. It was also found that metal fluoride formed at off-scar areas. This suggests the formation of reactive species, such as COF2 or R(sub f)COF, during sliding experiments, which can diffuse through the lubricant film and react with the metallic surfaces away from the contact region. Comparison of reference specimens before sliding with those that had undergone the sliding tests showed that the amount of non-degraded PFPE remaining on the surface of the balls after the sliding experiments was greater than that of the balls without sliding.

Guidelines for the planning and preparation of illustrated technical talks

NASA Technical Reports Server (NTRS)

Hubbard, H. H.

1975-01-01

Guidelines are presented for the preparation of illustrated talks which are audience oriented and which are aimed at the efficient transfer of technical information. Early decisions concerning the required number of slides are helpful in initial planning for a good quality talk. Detailed considerations are: the establishment of limited objectives, selection of appropriate slide material, development of a text which is well coordinated with the slides, and accurate timing.

Idiopathic granulomatous mastitis associated with risperidone-induced hyperprolactinemia

PubMed Central

2012-01-01

Idiopathic granulomatous mastitis (IGM) is a rare inflammatory breast disease. The etiology and treatment options of IGM remain controversial. Previous case reports have suggested that hyperprolactinemia may be associated with IGM. In the present report, we describe the first case of IGM associated with risperidone-induced hyperprolactinemia. Virtual slides The virtual slide(s) for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/8120093785928228 PMID:22221904

Adaptive sliding mode control for a class of chaotic systems

DOE Office of Scientific and Technical Information (OSTI.GOV)

Farid, R.; Ibrahim, A.; Zalam, B., E-mail: ramy5475@yahoo.com

2015-03-30

Chaos control here means to design a controller that is able to mitigating or eliminating the chaos behavior of nonlinear systems that experiencing such phenomenon. In this paper, an Adaptive Sliding Mode Controller (ASMC) is presented based on Lyapunov stability theory. The well known Chua's circuit is chosen to be our case study in this paper. The study shows the effectiveness of the proposed adaptive sliding mode controller.

76 FR 20588 - FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities; Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

.... FDA-2011-N-0251] FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities... comment. SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting entitled ``FDA... controls for facilities provisions of the recently enacted FDA Food Safety Modernization Act (FSMA). FDA is...

WEBSLIDE: A "Virtual" Slide Projector Based on World Wide Web.

ERIC Educational Resources Information Center

Barra, Maria; Ferrandino, Salvatore; Scarano, Vittorio

1999-01-01

Presents the key design concepts of a software project whose objective is to provide a simple, cheap, and efficient solution for showing slides during lessons in computer labs. Contains 26 references. (DDR)

Drugs@FDA: FDA Approved Drug Products

MedlinePlus

... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

Avelumab Impresses in Merkel Cell Carcinoma.

PubMed

2017-06-01

The PD-L1 inhibitor avelumab-approved by the FDA in March for the treatment of Merkel cell carcinoma-demonstrated a high number of durable responses in an international, open-label, prospective phase II study. The results of the study, which supported the FDA's decision, were presented in April at the American Association for Cancer Research (AACR) Annual Meeting 2017. ©2017 American Association for Cancer Research.

FDA regulation of labeling and promotional claims in therapeutic color vision devices: a tutorial.

PubMed

Drum, Bruce

2004-01-01

The Food and Drug Administration (FDA) is responsible for determining whether medical device manufacturers have provided reasonable assurance, based on valid scientific evidence, that new devices are safe and effective for their intended use before they are introduced into the U.S. market. Most existing color vision devices pose so little risk that their manufacturers are not required to submit a premarket notification [510(k)] to FDA prior to market. However, even low-risk devices may not be acceptable if they are marketed on the basis of misleading or excessive claims. Although most color vision devices are diagnostic, two types that are therapeutic rather than diagnostic are colored lenses intended to improve deficient color vision and colored lenses intended to improve reading performance. Both of these devices have presented special regulatory challenges to FDA because the intended uses and effectiveness claims initially proposed by the manufacturers were not supported by valid scientific evidence. In each instance, however, FDA worked with the manufacturer to restrict labeling and promotional claims in ways that were consistent with the available device performance data and that allowed for the legal marketing of the device.

The Use of Published Clinical Study Reports to Support U.S. Food and Drug Administration Approval of Imaging Agents.

PubMed

Rieves, Dwaine; Jacobs, Paula

2016-12-01

Pharmaceutical companies typically perform prospective, multicenter phase 3 clinical studies to support approval of a new imaging agent by the U.S. Food and Drug Administration (FDA). In uncommon situations, the FDA has approved imaging agents based solely, or in large part, on the clinical study experience described in published reports, including reports of exploratory (i.e., phase 1 or 2) studies performed at a single clinical site. We performed a survey of published reports to assess the potential of the reported information to support FDA approval of a commonly cited investigational imaging agent. Our survey revealed critical data limitations in most publications, all of which reported exploratory clinical studies. Here we summarize the precedent for FDA approval of imaging agents using effectiveness data from publications, FDA guidance, and our experience in reviewing publications. We also present a key-data checklist for investigators to consider in the design, conduct, and reporting of exploratory clinical studies for publication. We encourage editors and peer reviewers to consider requiring these key data when reviewing these reports for publication. © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Experimental study on bubble dynamics and wall heat transfer arising from a single nucleation site at subcooled flow boiling conditions – Part 2: Data analysis on sliding bubble characteristics and associated wall heat transfer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yooa, Junsoo; Estrada-Perez, Carlos E.; Hassan, Yassin A.

In this second of two companion papers presents an analysis of sliding bubble and wall heat transfer parameters measured during subcooled boiling in a square, vertical, upward flow channel. Bubbles were generated only from a single nucleation site for better observation of both the sliding bubbles’ characteristics and their impact on wall heat transfer through optical measurement techniques. Specific interests include: (i) bubbles departure and subsequent growth while sliding, (ii) bubbles release frequency, (iii) coalescence of sliding bubbles, (iv) sliding bubbles velocity, (v) bubbles size distribution and (vi) wall heat transfer influenced by sliding bubbles. Our results showed that slidingmore » bubbles involve two distinct growth behaviors: (i) at low mass fluxes, sliding bubbles grew fast near the nucleation site, subsequently shrank, and then grew again, (ii) as mass flux increased, however, sliding bubbles grew more steadily. The bubbles originating from the single nucleation site coalesced frequently while sliding, which showed close relation with bubbles release frequency. The sliding bubble velocity near the nucleation site consistently decreased by increasing mass flux, while the observation often became reversed as the bubbles slid downstream due to the effect of interfacial drag. The sliding bubbles moved faster than the local liquid (i.e., ur<0) at low mass flux conditions, but it became reversed as the mass flux increased. The size distribution of sliding bubbles followed Gaussian distribution well both near and far from the nucleation site. The standard deviation of bubble size varied insignificantly through sliding compared to the changes in mean bubble size. Lastly, the sliding bubbles enhanced the wall heat transfer and the effect became more noticeable as inlet subcooling/mass flux decreased or wall heat flux increased. Particularly, the sliding bubble characteristics such as bubble growth behavior observed near the nucleation site played a dominant role in determining the ultimate level of wall heat transfer enhancement within the test channel.« less

Experimental study on bubble dynamics and wall heat transfer arising from a single nucleation site at subcooled flow boiling conditions – Part 2: Data analysis on sliding bubble characteristics and associated wall heat transfer

DOE PAGES

Yooa, Junsoo; Estrada-Perez, Carlos E.; Hassan, Yassin A.

2016-04-28

In this second of two companion papers presents an analysis of sliding bubble and wall heat transfer parameters measured during subcooled boiling in a square, vertical, upward flow channel. Bubbles were generated only from a single nucleation site for better observation of both the sliding bubbles’ characteristics and their impact on wall heat transfer through optical measurement techniques. Specific interests include: (i) bubbles departure and subsequent growth while sliding, (ii) bubbles release frequency, (iii) coalescence of sliding bubbles, (iv) sliding bubbles velocity, (v) bubbles size distribution and (vi) wall heat transfer influenced by sliding bubbles. Our results showed that slidingmore » bubbles involve two distinct growth behaviors: (i) at low mass fluxes, sliding bubbles grew fast near the nucleation site, subsequently shrank, and then grew again, (ii) as mass flux increased, however, sliding bubbles grew more steadily. The bubbles originating from the single nucleation site coalesced frequently while sliding, which showed close relation with bubbles release frequency. The sliding bubble velocity near the nucleation site consistently decreased by increasing mass flux, while the observation often became reversed as the bubbles slid downstream due to the effect of interfacial drag. The sliding bubbles moved faster than the local liquid (i.e., ur<0) at low mass flux conditions, but it became reversed as the mass flux increased. The size distribution of sliding bubbles followed Gaussian distribution well both near and far from the nucleation site. The standard deviation of bubble size varied insignificantly through sliding compared to the changes in mean bubble size. Lastly, the sliding bubbles enhanced the wall heat transfer and the effect became more noticeable as inlet subcooling/mass flux decreased or wall heat flux increased. Particularly, the sliding bubble characteristics such as bubble growth behavior observed near the nucleation site played a dominant role in determining the ultimate level of wall heat transfer enhancement within the test channel.« less

Excimer laser photorefractive keratectomy for myopia: preliminary results at one year

NASA Astrophysics Data System (ADS)

Thompson, Keith P.; Waring, George O., III; Steinert, Roger; Durrie, Daniel S.; Gordon, Michael; Brint, Stephen F.

1992-08-01

Excimer laser photorefractive keratectomy (PRK) is presently under investigation for the correction of myopia. Two companies in the United States, Summit Technology (Waltham, Mass.) and VisX, Inc. (Sunnyvale, Calif.) have developed excimer laser delivery systems and are participating in an FDA study to determine the safety and efficacy of PRK. This is a preliminary report on the refractive and visual results of 51 of 100 eyes treated between October 10, 1990 and March 7, 1991 by the Summit Technology UV200LA excimer laser under the FDA Phase IIB FDA protocol one year after surgery. More detailed information on eight patients treated at Emory University Eye Center (Emory Subgroup) is also reported.

Optoelectronic hit/miss transform for screening cervical smear slides

NASA Astrophysics Data System (ADS)

Narayanswamy, R.; Turner, R. M.; McKnight, D. J.; Johnson, K. M.; Sharpe, J. P.

1995-06-01

An optoelectronic morphological processor for detecting regions of interest (abnormal cells) on a cervical smear slide using the hit/miss transform is presented. Computer simulation of the algorithm tested on 184 Pap-smear images provided 95% detection and 5% false alarm. An optoelectronic implementation of the hit/miss transform is presented, along with preliminary experimental results.

An Experimental Study of the Use of Visual Illustrations Used to Complement Oral Instruction on Television.

ERIC Educational Resources Information Center

Dwyer, Francis M., Jr.

Five slide sequences, each containing 39 black-and-white slides designed to complement oral instruction, and carrying a 32 minute oral instructional unit on the heart, were presented to 269 college students in five groups through a television receiver. The purpose was twofold: to determine if redundant information presented simultaneously through…

A Communication Device for Interfacing Slide/Audio Tape Programs with the Microcomputer for Computer-Assisted Self-Instruction.

ERIC Educational Resources Information Center

Hostetler, Jerry C.; Englert, Duwayne C.

1987-01-01

Presents description of an interface device which ties in microcomputers and slide/tape presentations for computer assisted instruction. Highlights include the use of this technology in an introductory undergraduate zoology course; a discussion of authoring languages with emphasis on SuperPILOT; and hardware and software design for the interface.…

A Locally Adaptive Regularization Based on Anisotropic Diffusion for Deformable Image Registration of Sliding Organs

PubMed Central

Pace, Danielle F.; Aylward, Stephen R.; Niethammer, Marc

2014-01-01

We propose a deformable image registration algorithm that uses anisotropic smoothing for regularization to find correspondences between images of sliding organs. In particular, we apply the method for respiratory motion estimation in longitudinal thoracic and abdominal computed tomography scans. The algorithm uses locally adaptive diffusion tensors to determine the direction and magnitude with which to smooth the components of the displacement field that are normal and tangential to an expected sliding boundary. Validation was performed using synthetic, phantom, and 14 clinical datasets, including the publicly available DIR-Lab dataset. We show that motion discontinuities caused by sliding can be effectively recovered, unlike conventional regularizations that enforce globally smooth motion. In the clinical datasets, target registration error showed improved accuracy for lung landmarks compared to the diffusive regularization. We also present a generalization of our algorithm to other sliding geometries, including sliding tubes (e.g., needles sliding through tissue, or contrast agent flowing through a vessel). Potential clinical applications of this method include longitudinal change detection and radiotherapy for lung or abdominal tumours, especially those near the chest or abdominal wall. PMID:23899632

A locally adaptive regularization based on anisotropic diffusion for deformable image registration of sliding organs.

PubMed

Pace, Danielle F; Aylward, Stephen R; Niethammer, Marc

2013-11-01

We propose a deformable image registration algorithm that uses anisotropic smoothing for regularization to find correspondences between images of sliding organs. In particular, we apply the method for respiratory motion estimation in longitudinal thoracic and abdominal computed tomography scans. The algorithm uses locally adaptive diffusion tensors to determine the direction and magnitude with which to smooth the components of the displacement field that are normal and tangential to an expected sliding boundary. Validation was performed using synthetic, phantom, and 14 clinical datasets, including the publicly available DIR-Lab dataset. We show that motion discontinuities caused by sliding can be effectively recovered, unlike conventional regularizations that enforce globally smooth motion. In the clinical datasets, target registration error showed improved accuracy for lung landmarks compared to the diffusive regularization. We also present a generalization of our algorithm to other sliding geometries, including sliding tubes (e.g., needles sliding through tissue, or contrast agent flowing through a vessel). Potential clinical applications of this method include longitudinal change detection and radiotherapy for lung or abdominal tumours, especially those near the chest or abdominal wall.

Universal fuzzy integral sliding-mode controllers for stochastic nonlinear systems.

PubMed

Gao, Qing; Liu, Lu; Feng, Gang; Wang, Yong

2014-12-01

In this paper, the universal integral sliding-mode controller problem for the general stochastic nonlinear systems modeled by Itô type stochastic differential equations is investigated. One of the main contributions is that a novel dynamic integral sliding mode control (DISMC) scheme is developed for stochastic nonlinear systems based on their stochastic T-S fuzzy approximation models. The key advantage of the proposed DISMC scheme is that two very restrictive assumptions in most existing ISMC approaches to stochastic fuzzy systems have been removed. Based on the stochastic Lyapunov theory, it is shown that the closed-loop control system trajectories are kept on the integral sliding surface almost surely since the initial time, and moreover, the stochastic stability of the sliding motion can be guaranteed in terms of linear matrix inequalities. Another main contribution is that the results of universal fuzzy integral sliding-mode controllers for two classes of stochastic nonlinear systems, along with constructive procedures to obtain the universal fuzzy integral sliding-mode controllers, are provided, respectively. Simulation results from an inverted pendulum example are presented to illustrate the advantages and effectiveness of the proposed approaches.

2016 T Division Lightning Talks

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ramsey, Marilyn Leann; Adams, Luke Clyde; Ferre, Gregoire Robing

These are the slides for all of the 2016 T Division lightning talks. There are 350 pages worth of slides from different presentations, all of which cover different topics within the theoretical division at Los Alamos National Laboratory (LANL).

Robust stabilization of underactuated nonlinear systems: A fast terminal sliding mode approach.

PubMed

Khan, Qudrat; Akmeliawati, Rini; Bhatti, Aamer Iqbal; Khan, Mahmood Ashraf

2017-01-01

This paper presents a fast terminal sliding mode based control design strategy for a class of uncertain underactuated nonlinear systems. Strategically, this development encompasses those electro-mechanical underactuated systems which can be transformed into the so-called regular form. The novelty of the proposed technique lies in the hierarchical development of a fast terminal sliding attractor design for the considered class. Having established sliding mode along the designed manifold, the close loop dynamics become finite time stable which, consequently, result in high precision. In addition, the adverse effects of the chattering phenomenon are reduced via strong reachability condition and the robustness of the system against uncertainties is confirmed theoretically. A simulation as well as experimental study of an inverted pendulum is presented to demonstrate the applicability of the proposed technique. Copyright © 2016 ISA. Published by Elsevier Ltd. All rights reserved.

Living and Working in Space

NASA Technical Reports Server (NTRS)

Roman, Monserrate C.

2000-01-01

This document is a presentation about some of the challenges of living and working in space. The presentation shows slides of the Apollo 11 liftoff, Skylab in orbit, a Space Shuttle launch, and a slide of the International Space Station. It reviews the needs and effluents of the astronauts per day, and the Environmental Control and Life Support (ECLS) systems. It shows a flow diagram of the Space Station Regenerative ECLS, which shows the various systems, and how they interact to control the environment and recycle the air, and water. There are other slides some of which show astronauts eating, brushing teeth, shaving, and sipping from a sip bottle while exercising.

Apparatus for correcting precision errors in slide straightness in machine tools

DOEpatents

Robinson, Samuel C.; Gerth, Howard L.

1981-01-01

The present invention is directed to a mechanism by which small deviations in slideway straightness and roll of a precision machining apparatus may be compensated for. The mechanism of the present invention comprises a fixture support disposed between the slideway carriage and the tool or workpiece fixture and provided with a hinge-like coupling between the carriage and the fixture support so as to allow for the minute and precise displacement of the fixture support in a direction normal to the direction of the slide path so as to readily compensate for slight deviations in the straightness and roll of the slide path.

Apparatus for correcting precision errors in slide straigntness in machine tools

DOEpatents

Robinson, S.C.; Gerth, H.L.

The present invention is directed to a mechanism by which small deviations in slideway straightness and roll of a precision machining apparatus may be compensated for. The mechanism of the present invention comprises a fixture support disposed between the slideway carriage and the tool or workpiece fixture and provided with a hinge-like coupling between the carriage and the fixture support so as to allow for the minute and precise displacement of the fixture support in a direction normal to the direction of the slide path soa as to readily compensate for slight deviations in the straightness and roll of the slide path.

Calculations of turbidite deposits and tsunamis from submarine landslides

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gisler, Galen R; Weaver, Robert P; Gittings, Michael L

2009-01-01

Great underwater landslides like Storegga off the Norwegian coast leave massive deposits on the seafloor and must produce enormous tsunamis. Such events have occurred on continental slopes worldwide, and continue to do so. Triggers for such slides include earthquakes, gas hydrate releases, and underwater volcanos. We have petformed a numerical study of such landslides using the multi-material compressible hydrocode Sage in order to understand the relationship between the rheology of the slide material, the configuration of the resulting deposits on the seafloor, and the tsunami that is produced. Instabilities in the fluid-fluid mixing between slide material and seawater produce vorticesmore » and swirls with sizes that depend on the rheology of the slide material. These dynamical features of the flow may be preserved as ridges when the sliding material finally stops. Thus studying the configuration of the ridges in prehistoric slides may give us measures of the circumstances under which the slide was initiated. As part of this study, we have also done a convergence test showing that the slide velocity is sensitive to the resolution adopted in the simulation, but that extrapolation to infinite resolution is possible, and can yield good velocities. We will present two-dimensional simulations of schematic underwater slides for our study of rheology, and a three-dimensional simulation in bathymetric conditions that resemble the pre-Storegga Norwegian margin.« less

The Shear Properties of Langmuir-Blodgett Layers

NASA Astrophysics Data System (ADS)

Briscoe, B. J.; Evans, D. C. B.

1982-04-01

The sliding friction between two highly oriented monolayers has been studied by using molecularly smooth mica substrates in the form of contacting orthogonal cylinders. The monolayers in the form of various normal alipathic carboxylic acids and their soaps were deposited with the aid of the Langmuir-Blodgett technique by transfer from aqueous substrates. The normal alkyl group has been varied in length from 14 to 22 methylene repeat units. Data are reported also on the influence of partial saponification of the carboxylic acid and fluorination of the alkyl chain. Most of the investigation has been confined to two contacting single monolayers although a limited amount of data is presented for multilayers sliding over one another. The character of the sliding motion depends not only on the machine but also on the monolayers, particularly their chemistry. Most of the monolayers studied provide a continuous rate of energy dissipation. However, a small number, such as certain soaps, show discontinuous or stick-slip motion. The experimental arrangement allows simultaneous measurement of the sliding frictional force, contact area and film thickness to be made during sliding. In some experiments this friction is the monotonic sliding friction but in others it is the mean maximum value during the stick phase. The film thickness measurement is accurate to 0.2 mm which allows a precise assessment of the shear plane during sliding. In all cases the monolayers and multilayers were found to be extremely durable and shear invariably occurred at the original interface between the monolayers. The sliding friction data are presented as the dynamic specific friction force or interface shear strength, and a number of contact variables have been examined. These include the applied normal load per unit contact area or mean contact pressure, the temperature and the sliding velocity. The interface shear strength is found, to a good approximation, to increase linearly with mean contact pressure but to decrease linearly with temperature in the ranges studied. The influence of sliding velocity is more complex. In the case where intermittent motion is detected the mean maximum values decrease linearly with the logarithm of the velocity.

Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study.

PubMed

Jadhav, Pravin R; Zhang, Jialu; Gobburu, Jogarao V S

2009-01-01

The manuscript presents the FDA's focus on leveraging prior knowledge in designing informative pediatric trial through this case study. In developing written request for Drug X, an anti-hypertensive for immediate blood pressure (BP) control, the sponsor and FDA conducted clinical trial simulations (CTS) to design trial with proper sample size and support the choice of dose range. The objective was to effectively use prior knowledge from adult patients for drug X, pediatric data from Corlopam (approved for a similar indication) trial and general experience in developing anti-hypertensive agents. Different scenarios governing the exposure response relationship in the pediatric population were simulated to perturb model assumptions. The choice of scenarios was based on the past observation that pediatric population is less responsive and sensitive compared with adults. The conceptual framework presented here should serve as an example on how the industry and FDA scientists can collaborate in designing the pediatric exclusivity trial. Using CTS, inter-disciplinary scientists with the sponsor and FDA can objectively discuss the choice of dose range, sample size, endpoints and other design elements. These efforts are believed to yield plausible trial design, qrational dosing recommendations and useful labeling information in pediatrics. Published in 2009 by John Wiley & Sons, Ltd.

New FDA draft guidance on immunogenicity.

PubMed

Parenky, Ashwin; Myler, Heather; Amaravadi, Lakshmi; Bechtold-Peters, Karoline; Rosenberg, Amy; Kirshner, Susan; Quarmby, Valerie

2014-05-01

A "Late Breaking" session was held on May 20 at the 2013 American Association of Pharmaceutical Scientists-National Biotech Conference (AAPS-NBC) to discuss the US Food and Drug Administration's (FDA) 2013 draft guidance on Immunogenicity Assessment for Therapeutic Protein Products. The session was initiated by a presentation from the FDA which highlighted several key aspects of the 2013 draft guidance pertaining to immunogenicity risk, the potential impact on patient safety and product efficacy, and risk mitigation. This was followed by an open discussion on the draft guidance which enabled delegates from biopharmaceutical companies to engage the FDA on topics that had emerged from their review of the draft guidance. The multidisciplinary audience fostered an environment that was conducive to scientific discussion on a broad range of topics such as clinical impact, immune mitigation strategies, immune prediction and the role of formulation, excipients, aggregates, and degradation products in immunogenicity. This meeting report highlights several key aspects of the 2013 draft guidance together with related dialog from the session.

Test Fixture for Determination of Energy Absorbing Capabilities of Composite Materials

NASA Technical Reports Server (NTRS)

Lavoie, J. Andre (Inventor); Jackson, Karen E. (Inventor); Morton, John (Inventor)

1998-01-01

The present invention provides a fixture for supporting an elongated specimen for crush testing. The fixture comprises a base plate. four guiding rods, a sliding plate, four support rods and two collars. The guiding rods connect to the base plate and extend in a direction substantially perpendicular to the base plate. The sliding plate has linear bearings which encircle the guiding rods and enable translation of the sliding plate along the axis of each guiding rod. The four supporting rods mount to the base plate and also extend in a direction substantially perpendicular to the base plate. Each support rod has a keyway for a wedge which contacts the elongated specimen and holds the specimen in place during crushing. Each collar lies above the sliding plate and holds a pair of support rods on their ends opposite the ends connected to the base plate. A spherical bearing sits on top of the sliding plate and transfers an applied load to the sliding plate, which moves downward and crushes the elongated specimen.

Test fixture for determination of energy absorbing capabilities of composite materials

NASA Technical Reports Server (NTRS)

Lavoie, J. Andre (Inventor); Jackson, Karen E. (Inventor); Morton, John (Inventor)

1994-01-01

The present invention provides a fixture for supporting an elongated specimen for crush testing. The fixture comprises a base plate, four guiding rods, a sliding plate, four support rods and two collars. The guiding rods connect to the base plate and extend in a direction substantially perpendicular to the base plate. The sliding plate has linear bearings which encircle the guiding rods and enable translation of the sliding plate along the axis of each guiding rod. The four supporting rods mount to the base plate and also extend in a direction substantially perpendicular to the base plate. Each support rod has a keyway for a wedge which contacts the elongated specimen and holds the specimen in place during crushing. Each collar lies above the sliding plate and holds a pair of support rods on their ends opposite the ends connected to the base plate. A spherical bearing sits on top of the sliding plate and transfers an applied load to the sliding plate, which moves downward and crushes the elongated specimen.

Visual memory effects on intraoperator study design: determining a minimum time gap between case reviews to reduce recall bias.

PubMed

Campbell, W Scott; Talmon, Geoffrey A; Foster, Kirk W; Baker, John J; Smith, Lynette M; Hinrichs, Steven H

2015-03-01

The objective of this research was to determine test intervals between intraoperator case reviews to minimize the impact of recall. Three pathologists were presented with a group of 120 slides and subsequently challenged with a study set of 120 slides after 2-week and 4-week intervals. The challenge set consisted of 60 slides seen during the initial review and 60 slides previously unseen within the study. Pathologists rendered a diagnosis for each slide and indicated whether they recalled seeing the slide previously (yes/no). Two weeks after having been shown 60 cases from a challenge set of 120 cases, the pathologists correctly remembered 26, 22, and 24 cases or 40% overall. After 4 weeks, the pathologists correctly recalled 31% of cases previously seen. Pathologists were capable of recalling from memory cases seen previously at 2 and 4 weeks. Recall rates may be sufficiently high to affect intraobserver study design. Copyright© by the American Society for Clinical Pathology.

Sliding mode output feedback control based on tracking error observer with disturbance estimator.

PubMed

Xiao, Lingfei; Zhu, Yue

2014-07-01

For a class of systems who suffers from disturbances, an original output feedback sliding mode control method is presented based on a novel tracking error observer with disturbance estimator. The mathematical models of the systems are not required to be with high accuracy, and the disturbances can be vanishing or nonvanishing, while the bounds of disturbances are unknown. By constructing a differential sliding surface and employing reaching law approach, a sliding mode controller is obtained. On the basis of an extended disturbance estimator, a creative tracking error observer is produced. By using the observation of tracking error and the estimation of disturbance, the sliding mode controller is implementable. It is proved that the disturbance estimation error and tracking observation error are bounded, the sliding surface is reachable and the closed-loop system is robustly stable. The simulations on a servomotor positioning system and a five-degree-of-freedom active magnetic bearings system verify the effect of the proposed method. Copyright © 2014 ISA. Published by Elsevier Ltd. All rights reserved.

Probing superlubricity stability of hydrogenated diamond-like carbon film by varying sliding velocity

NASA Astrophysics Data System (ADS)

Liu, Yunhai; Yu, Bingjun; Cao, Zhongyue; Shi, Pengfei; Zhou, Ningning; Zhang, Bin; Zhang, Junyan; Qian, Linmao

2018-05-01

In this study, the superlubricity stability of hydrogenated diamond-like carbon (H-DLC) film in vacuum was investigated by varying the sliding velocity (30-700 mm/s). The relatively stable superlubricity state can be maintained for a long distance at low sliding velocity, whereas the superlubricity state quickly disappears and never recovers at high sliding velocity. Under superlubricity state, the transfer layer of H-DLC film was observed on the Al2O3 ball, which played a key role in obtaining ultra-low friction coefficient. Although the transfer layer can be generated at the beginning of the test, high-velocity sliding tends to accelerate the superlubricity failure and leads to the severe wear of H-DLC film. Analysis indicated that the main reason for superlubricity failure at high sliding velocity is not attributed to friction heat or the break of hydrogen passivation but to the absence of transfer layer on Al2O3 ball. The present study can enrich the understanding of superlubricity mechanism of H-DLC film.

The physics of sliding cylinders and curling rocks

NASA Astrophysics Data System (ADS)

Penner, A. Raymond

2001-03-01

The lateral deflection of a rotating cylindrical shell sliding on one of its ends is considered and both theoretical and experimental results are presented. The coefficient of kinetic friction between a curling rock and an ice surface is then derived and compared with experiment. Current models of the motion of a curling rock are discussed and an alternate hypothesis is presented.

Advertising for the 80's. Marketing and Distributive Education. Advertising. Instructor's Guide.

ERIC Educational Resources Information Center

Ault, Craig; Elias, John

This module contains a teacher's guide, student materials for a seminar on "advertising for the 80's" conducted for small business representatives, a 35mm slide presentation, and an audiocassette. The instructor guide contains an outline of the course, time plan, end-of-course critique, a script for the slide-tape presentation (with content on the…

Wear Characteristics of Ni-Based Hardfacing Alloy Deposited on Stainless Steel Substrate by Laser Cladding

NASA Astrophysics Data System (ADS)

Awasthi, Reena; Limaye, P. K.; Kumar, Santosh; Kushwaha, Ram P.; Viswanadham, C. S.; Srivastava, Dinesh; Soni, N. L.; Patel, R. J.; Dey, G. K.

2015-03-01

In this study, dry sliding wear characteristics of the Ni-based hardfacing alloy (Ni-Mo-Cr-Si) deposited on stainless steel SS316L substrate by laser cladding have been presented. Dry sliding wear behavior of the laser clad layer was evaluated against two different counter bodies, AISI 52100 chromium steel (~850 VHN) and tungsten carbide ball (~2200 VHN) to study both adhesive and abrasive wear characteristics, in comparison with the substrate SS316L using ball on plate reciprocating wear tester. The wear resistance was evaluated as a function of load and sliding speed for a constant sliding amplitude and sliding distance. The wear mechanisms were studied on the basis of wear surface morphology and microchemical analysis of the wear track using SEM-EDS. Laser clad layer of Ni-Mo-Cr-Si on SS316L exhibited much higher hardness (~700 VHN) than that of substrate SS316L (~200 VHN). The laser clad layer exhibited higher wear resistance as compared to SS316L substrate while sliding against both the counterparts. However, the improvement in the wear resistance of the clad layer as compared to the substrate was much higher while sliding against AISI 52100 chromium steel than that while sliding against WC, at the same contact stress intensity.

Patient-Focused Drug Development: A New Direction for Collaboration.

PubMed

Perfetto, Eleanor M; Burke, Laurie; Oehrlein, Elisabeth M; Epstein, Robert S

2015-01-01

Patient-Focused Drug Development (PFDD) is a new initiative from the Food and Drug Administration (FDA) intended to bring patient perspectives into an earlier stage of product development. The goal is that patients will be able to provide context for benefit-risk assessments and input to review divisions, and also aid in the development of new assessment tools, study endpoints, and risk communications. This paper provides a summary on what is known to date about FDA's PFDD initiative and describes implications for patients, researchers, payers, and the biopharmaceutical industry. It also provides a roadmap for stakeholders to consider in defining their role in and in shaping PFDD's direction, and for expanding PFDD principles to conditions beyond the current 20 under FDA consideration. A search was conducted of the peer-reviewed and gray literature using PubMed and Google. This included laws, FDA guidance documents, the peer-reviewed literature, and FDA presentations for content relevant to the search term "patient-focused drug development." Currently, FDA activities within PFDD are limited to gaining patient insights through 20 disease-specific meetings. However, many stakeholders see the initiative much more generally as representing a broad shift toward patient centeredness in biopharmaceutical product development. Depending upon the trajectory taken and whether or not all PFDD aims are eventually addressed, the initiative has the potential to change product development in fundamental ways. Further research should explore how patient input on disease manifestation and treatment options is best ascertained from patients and documented before initiating and during drug development.

Adaptive fuzzy sliding control of single-phase PV grid-connected inverter.

PubMed

Fei, Juntao; Zhu, Yunkai

2017-01-01

In this paper, an adaptive fuzzy sliding mode controller is proposed to control a two-stage single-phase photovoltaic (PV) grid-connected inverter. Two key technologies are discussed in the presented PV system. An incremental conductance method with adaptive step is adopted to track the maximum power point (MPP) by controlling the duty cycle of the controllable power switch of the boost DC-DC converter. An adaptive fuzzy sliding mode controller with an integral sliding surface is developed for the grid-connected inverter where a fuzzy system is used to approach the upper bound of the system nonlinearities. The proposed strategy has strong robustness for the sliding mode control can be designed independently and disturbances can be adaptively compensated. Simulation results of a PV grid-connected system verify the effectiveness of the proposed method, demonstrating the satisfactory robustness and performance.

78 FR 19715 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and...: The Food and Drug Administration (FDA) is extending the comment period for the notice entitled...

AIR TOXICS MODELING RESEARCH PROGRAM: AN OVERVIEW

EPA Science Inventory

This product is a Microsoft Powerpoint slide presentation which was given at the joint EPA Region 3 - Mid-Atlantic Regional Air Management Association (MARAMA) Air Toxic Summit in Philadelphia, Pennsylvania held from October 18, 2005 through October 20, 2005. The slide presentat...

77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...

78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-07

..., FDA- 2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability...\\ February 16, 2011. Adjustable Gastric Banding System. P100049, FDA-2012-M-0893....... Torax Medical, Inc.... Trabecular Micro- Bypass Stent and Inserter. P110007, FDA-2012-M-0734....... Abbott Medical Healon[supreg...

75 FR 76992 - Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0072] (formerly Docket No. 2005D-0042) Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings; Availability AGENCY: Food and Drug...

78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and... information. SUMMARY: In September 2011, the Food and Drug Administration (FDA or the Agency) asked the...

Evaluation of four slide test kits for the detection of human chorionic gonadotropin in urine

PubMed Central

Dietrich, Michael; French, J. A.

1974-01-01

Three “indirect-type” slide tests utilizing the principle of hemagglutination inhibition and one new “direct-type” slide test employing direct agglutination were evaluated for their sensitivity in detecting human chorionic gonadotropin (HCG) in urine. The results of positive tests in a group of woman in very early pregnancy were correlated with the “days after last menses”. In this series the direct slide test was the most accurate. A control must be used with each direct test to indicate interfering substances and when such are present a different test must be used. All tests were found to be of the relative sensitivity stated by the manufacturer. PMID:4851924

The Edison Environmental Center Permeable Pavement Site - slides

EPA Science Inventory

This is a presentation for a second Community Outreach Event called "Chemistry Works!" at West Windsor Public Library on Saturday, November 5th. It will review the permeable pavement research project at the Edison Environmental center. Besides slide persentation, two demo units w...

Surface profiles and modulation of ultra-thin perfluoropolyether lubricant in contact sliding

NASA Astrophysics Data System (ADS)

Sinha, S. K.; Kawaguchi, M.; Kato, T.

2004-08-01

Deformation in shear and associated tribological behaviours of ultra-thin lubricants are of significant importance for the lubrication of magnetic hard disks and for other applications such as micro-electromechanical systems, nano-fluidics and nanotechnology. This paper presents the characteristics of the perfluoropolyether ultra-thin lubricant, in terms of its surface profiles when subjected to a contact sliding test. The results indicate that for a several-monolayers thick (~4.0-4.5 nm) lubricant film, sliding produces a considerable amount of surface roughness due to peaks of lubricant that persist during sliding; however, it can flow back or return to a smooth profile after a lapse of time when the sliding is stopped. For a monolayer-thin (~1.4-1.57 nm) film, the lubricant flow is restricted, and the rough profile created due to sliding persists and almost becomes permanent on the wear track. During sliding, due to high shear stress, a characteristic feature of lubricant profile modulation is observed. This modulation, or waviness, is due to the accumulation of lubricant in piles or islands, giving certain amplitudes and frequencies, which themselves depend upon the percentage of lubricant molecules that are chemically bonded to the substrate and the lubricant thickness. The results indicate that ultra-thin lubricants (monolayer and thicker) behave more like a semi-solid (having some sliding characteristics similar to those of rubbers) than a liquid when subjected to a high shear rate during contact sliding.

A comparison of viewer reactions to outdoor scenes and photographs of those scenes

Treesearch

Elwood, Jr. Shafer; Thomas A. Richards; Thomas A. Richards

1974-01-01

A color-slide projection or photograph can be used to determine reactions to an actual scene if the presentation adequately includes most of the elements in the scene. Eight kinds of scenes were subjected to three different types of presentation: (A) viewing. the actual scenes, (B) viewing color slides of the scenes, and (C) viewing color photographs of the scenes. For...

David Douglas Duncan's Changing Views on War: An Audio-Visual Presentation.

ERIC Educational Resources Information Center

Politowski, Richard

This paper is the script for a slide presentation about photographer David Douglas Duncan and his view of war. It is intended to be used with slides made from pictures Duncan took during World War II, the Korean War, and the war in Viet Nam and published in various books and periodicals. It discusses a shift in emphasis to be seen both in the…

Perceptions of the Food and Drug Administration as a Tobacco Regulator

PubMed Central

Jarman, Kristen L.; Ranney, Leah M.; Baker, Hannah M.; Vallejos, Quirina M.; Goldstein, Adam O.

2017-01-01

Objectives The U. S. Food and Drug Administration (FDA) now has regulatory authority over all tobacco products. Little is known about public awareness and perceptions of FDA in their new role as a tobacco regulator. This research utilizes focus groups to examine perceptions of FDA as a tobacco regulator so that FDA can better communicate with the public about this role. Methods We conducted 6 focus groups in 2014 among a diverse sample of smokers and non-smokers. Participants were asked if they had heard of FDA, what they knew about FDA, if they associated FDA with tobacco, and their thoughts about this FDA role. Results A total of 41 individuals participated. Although nearly all participants had heard of FDA, most were not aware of FDA’s regulatory authority over tobacco products, did not associate the role of FDA with tobacco, and some drew comparisons between FDA’s work in tobacco and their work regulating food and drugs. Conclusion Data suggest that although public awareness of FDA regulatory authority over tobacco is low, with proper public education, the public may find FDA to be a trustworthy source of tobacco regulation. PMID:29051917

Invariant polygons in systems with grazing-sliding.

PubMed

Szalai, R; Osinga, H M

2008-06-01

The paper investigates generic three-dimensional nonsmooth systems with a periodic orbit near grazing-sliding. We assume that the periodic orbit is unstable with complex multipliers so that two dominant frequencies are present in the system. Because grazing-sliding induces a dimension loss and the instability drives every trajectory into sliding, the system has an attractor that consists of forward sliding orbits. We analyze this attractor in a suitably chosen Poincare section using a three-parameter generalized map that can be viewed as a normal form. We show that in this normal form the attractor must be contained in a finite number of lines that intersect in the vertices of a polygon. However the attractor is typically larger than the associated polygon. We classify the number of lines involved in forming the attractor as a function of the parameters. Furthermore, for fixed values of parameters we investigate the one-dimensional dynamics on the attractor.

[Spatial orientation of the facies patellaris femoris].

PubMed

Hassenpflug, J; Hiss, E; Blauth, W

1987-01-01

The present article reports on the geometrical conditions of the physiological movement of the patella. The geometrical shape of 18 femoral condyles and patella sliding areas was investigated in order to describe basic data for the design of endoprostheses. Surface and direction of the facies patellaris femoris were determined by means of radiographic, mechanical and optical measurements. The curvature of the deepest patella sliding groove proves a constant correlation with the dorsal condylar curvature. In the frontal plane the lowest points of the sliding area run with a dispersion of +/- 4 degrees to the vertical line related to the transverse tangent on the dorsal condylar surface. Considering deviations of leg alignment the measures come close to an angle of about 0 degrees. So the direction of the patella sliding groove differs from the normal valgus position of the distal femur. Therefore in artificial knee replacement a lateral tilt of the patella sliding groove should not be propagated as 'physiological'.

Preliminary investigation of some large landslides triggered by the 2008 Wenchuan earthquake, Sichuan Province, China

USGS Publications Warehouse

Wang, F.; Cheng, Q.; Highland, L.; Miyajima, M.; Wang, Hongfang; Yan, C.

2009-01-01

The M s 8.0 Wenchuan earthquake or "Great Sichuan Earthquake" occurred at 14:28 p.m. local time on 12 May 2008 in Sichuan Province, China. Damage by earthquake-induced landslides was an important part of the total earthquake damage. This report presents preliminary observations on the Hongyan Resort slide located southwest of the main epicenter, shallow mountain surface failures in Xuankou village of Yingxiu Town, the Jiufengchun slide near Longmenshan Town, the Hongsong Hydro-power Station slide near Hongbai Town, the Xiaojiaqiao slide in Chaping Town, two landslides in Beichuan County-town which destroyed a large part of the town, and the Donghekou and Shibangou slides in Qingchuan County which formed the second biggest landslide lake formed in this earthquake. The influences of seismic, topographic, geologic, and hydro-geologic conditions are discussed. ?? 2009 Springer-Verlag.

Adaptive fuzzy sliding control of single-phase PV grid-connected inverter

PubMed Central

Zhu, Yunkai

2017-01-01

In this paper, an adaptive fuzzy sliding mode controller is proposed to control a two-stage single-phase photovoltaic (PV) grid-connected inverter. Two key technologies are discussed in the presented PV system. An incremental conductance method with adaptive step is adopted to track the maximum power point (MPP) by controlling the duty cycle of the controllable power switch of the boost DC-DC converter. An adaptive fuzzy sliding mode controller with an integral sliding surface is developed for the grid-connected inverter where a fuzzy system is used to approach the upper bound of the system nonlinearities. The proposed strategy has strong robustness for the sliding mode control can be designed independently and disturbances can be adaptively compensated. Simulation results of a PV grid-connected system verify the effectiveness of the proposed method, demonstrating the satisfactory robustness and performance. PMID:28797060

ATIS Data Collection Guidelines Workshop : what do ATIS customers want?

DOT National Transportation Integrated Search

2000-02-09

This website presents the slides from the ATIS Data Collection Guidelines Workshop held Feb. 9-10, 2000 at Scottsdale, Arizona. The slides depict consumers perspective on ATIS services, as well as why drivers consult ATIS and how they use it. Other i...

Management of a TIFS System: Organizing Tests with Instructional Feedback on Slides.

ERIC Educational Resources Information Center

Brown, F. Dale; Mitchell, Thomas O.

1980-01-01

Presents three components of the tests with instructional feedback on slides system (TIFS), the needs of the three, background on the production of the test item reference card, and the advantage of the system for both instructor and student. (MER)

Slides from the 2013 Smart Growth Summit on How to Learn from the New Orleans Urban Waters Partnership

EPA Pesticide Factsheets

Presentation Slides for 2013 Smart Growth Summit, Baton Rouge, LA, H2O Overview: How to Learn from the New Orleans Urban Waters Partnership - Danny Wiegand Urban Waters Ambassador to New Orleans November 19, 2013

Emotion-processing deficit in alexithymia.

PubMed

Roedema, T M; Simons, R F

1999-05-01

College undergraduates were identified as alexithymic or control, based on their scores on the Toronto Alexithymia Scale (TAS; Taylor, Ryan, & Bagby, 1985). All subjects were presented standardized emotion-eliciting color slides for 6 s while facial muscle, heart rate, and skin conductance activity were recorded. Stimuli were presented a second time while subjects were asked to provide emotion self-reports using a paper-and-pencil version of the Self-Assessment Manikin (SAM; Lang, 1980) and to generate a list of words describing their emotional reaction to each slide. Consistent with the definition of alexithymia as a syndrome characterized, in part, by a deficit in the identification of emotion states, high TAS subjects supplied fewer emotion-related words than did controls to describe their response to the slides. Alexithymics also indicated less variation along the arousal dimension of the SAM, produced fewer specific skin conductance responses and showed less heart rate deceleration to the slides, regardless of category. No valence-related differences between alexithymic and control subjects were noted.

Fair Balance and Adequate Provision in Direct-to-Consumer Prescription Drug Online Banner Advertisements: A Content Analysis.

PubMed

Adams, Crystal

2016-02-18

The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements. This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media. A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug's risks and side effects or of a "major statement" identifying the drug's major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of "fair balance," the FDA's requirement that prescription drug ads balance information relating to the drug's risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information. Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug's risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and none displayed negative images when presenting risks facts. When benefit facts were being presented, 7% (5/68) showed only positive images. No ads showed negative images when the benefit facts were being presented. In the face of ambiguous regulatory guidelines for online banner promotion, drug companies appear to make an attempt to adapt to regulatory guidelines designed for traditional media. However, banner ads use various techniques of presentation to present the advertised drug in the best possible light. The FDA should formalize requirements that drug companies provide a brief summary and include multiple forms of adequate provision in banner ads.

Lung Sliding Identification Is Less Accurate in the Left Hemithorax.

PubMed

Piette, Eric; Daoust, Raoul; Lambert, Jean; Denault, André

2017-02-01

The aim of our study was to compare the accuracy of lung sliding identification for the left and right hemithoraxes, using prerecorded short US sequences, in a group of physicians with mixed clinical and US training. A total of 140 US sequences of a complete respiratory cycle were recorded in the operating room. Each sequence was divided in two, yielding 140 sequences of present lung sliding and 140 sequences of absent lung sliding. Of these 280 sequences, 40 were randomly repeated to assess intraobserver variability, for a total of 320 sequences. Descriptive data, the mean accuracy of each participant, as well as the rate of correct answers for each of the original 280 sequences were tabulated and compared for different subgroups of clinical and US training. A video with examples of present and absent lung sliding and a lung pulse was shown before testing. Two sessions were planned to facilitate the participation of 75 clinicians. In the first group, the rate of accurate lung sliding identification was lower in the left hemithorax than in the right (67.0% [interquartile range (IQR), 43.0-83.0] versus 80.0% [IQR, 57.0-95.0]; P < .001). In the second group, the rate of accurate lung sliding identification was also lower in the left hemithorax than in the right (76.3% [IQR, 42.9-90.9] versus 88.7% [IQR, 63.1-96.9]; P = .001). Mean accuracy rates were 67.5% (95% confidence interval, 65.7-69.4) in the first group and 73.1% (95% confidence interval, 70.7-75.5) in the second (P < .001). Lung sliding identification seems less accurate in the left hemithorax when using a short US examination. This study was done on recorded US sequences and should be repeated in a live clinical situation to confirm our results. © 2016 by the American Institute of Ultrasound in Medicine.

Labeling of trans fatty acid content in food, regulations and limits-the FDA view.

PubMed

Moss, Julie

2006-05-01

With the scientific evidence associating trans fatty acid (TFA) intake with an increased risk of coronary heart disease (CHD), the U.S. Food and Drug Administration (FDA) issued a final rule that requires the declaration of the amount of TFA present in foods, including dietary supplements, on the nutrition label by January 1, 2006. The addition of TFA to the nutrition label will lead to the prevention of 600 to 1200 cases of CHD and 240-480 deaths each year saving Dollars 900 million to Dollars 1.8 billion per year in medical costs, lost productivity, and pain and suffering. For the purpose of nutrition labeling, TFA are defined as the sum of all unsaturated fatty acids that contain one or more isolated (i.e. non-conjugated) double bonds in a trans configuration. There are many issues that FDA has yet to resolve: (1) defining nutrient content claims for "free" and "reduced" levels of trans fat, (2) placing limits on the amount of TFA in conjunction with saturated fat limits for nutrient content claims, health claims, and disclosure and disqualifying levels, (3) a daily value, and (4) a possible footnote or disclosure statement to enhance consumer understanding of cholesterol raising lipids. FDA issued an Advanced Notice of Proposed Rulemaking (ANPR) requesting comments on the unresolved issues. FDA will also be conducting consumer research to determine consumer understanding of various TFA labeling possibilities. Comments to the ANPR, results of consumer research and current science will be used by FDA to resolve these issues and to determine future rulemaking for TFA labeling.

Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration

PubMed Central

Herz, Naomi; Loyo-Berrios, Nilsa; Tarver, Michelle

2014-01-01

Abstract Background: Disease presentation, prevalence, and treatment effects vary by sex, thus it is important to ensure adequate participation of both sexes in medical device post-approval studies (PAS). Methods: The goals of this study were to determine the participation rate of women in PAS mandated by the Food and Drug Administration (FDA) and if participation varied by clinical area. The study also evaluated the frequency in which enrollment by sex is reported by applicant reports and FDA reviews, as well as the frequency in which final study reports analyze whether outcomes differ by sex. Results: Of 89 studies with enrollment completed, data on sex of participants were available in 93% of submitted reports, while data on enrollment by sex was evaluated and noted in 43% of FDA review memos. Study participation varied by clinical area, with female participation ranging from 32% in cardiovascular PAS to 90% in PAS for reconstructive devices. Of 53 completed studies, data on enrollment by sex was provided in 49 of the final reports. Of these 14% included a multivariate analysis that included sex as a covariate and 4% included a subgroup analysis for female participants. Conclusions: Data on sex was not routinely assessed in FDA reviews. Based on these findings, FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews. FDA will continue working with applicants to develop PAS that enroll and retain proportions of women consistent with the sex-specific prevalence for the disease or condition the device is used to treat. PMID:24405314

Traction of elastohydrodynamic contacts with thermal shearing flow

NASA Technical Reports Server (NTRS)

Jakobsen, J.; Winer, W. O.

1974-01-01

The formulation and solution for the shear stress and temperature in heavily loaded sliding elastohydrodynamic contacts is presented. The solutions are presented in dimensionless design charts. Integration over the contact area will yield the traction. Accuracy is expected to be very good over the nearly flat part of the contact area where the majority of the sliding traction is generated. The procedure presented is not appropriate for thick film lubrication, for the inlet region, or for the rolling friction of elastohydrodynamic contacts.

DiTour 3.1

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pelaia II, Thomas A.

2015-06-30

There is a need for software that allows a tour guide to present different tracks of slides and then return to the default slide show automatically upon completion. A mobile solution is needed for trade shows. DiTour is an iPad/iPhone app that pulls presentation content from a website, stores it on the device and presents it on a connected display. A tour guide can select a track to present and it will automatically return to the default track after a timeout. It offers a mobile solution which is ideal for trade shows.

Variable structure control of spacecraft reorientation maneuvers

NASA Technical Reports Server (NTRS)

Sira-Ramirez, H.; Dwyer, T. A. W., III

1986-01-01

A Variable Structure Control (VSC) approach is presented for multi-axial spacecraft reorientation maneuvers. A nonlinear sliding surface is proposed which results in an asymptotically stable, ideal linear sliding motion of Cayley-Rodriques attitude parameters. By imposing a desired equivalent dynamics on the attitude parameters, the approach is devoid of optimal control considerations. The single axis case provides a design scheme for the multiple axes design problem. Illustrative examples are presented.

Robust and real-time rotor control with magnetic bearings

NASA Technical Reports Server (NTRS)

Sinha, A.; Wang, K. W.; Mease, K. L.

1991-01-01

This paper deals with the sliding mode control of a rigid rotor via radial magnetic bearings. The digital control algorithm and the results from numerical simulations are presented for an experimental rig. The experimental system which has been set up to digitally implement and validate the sliding mode control algorithm is described. Two methods for the development of control softwares are presented. Experimental results for individual rotor axis are discussed.

Ten simple rules for Lightning and PechaKucha presentations.

NASA Astrophysics Data System (ADS)

Lortie, C. J.

2016-12-01

An interesting opportunity has emerged that bridges the gap between lengthy, detailed presentations of scientific findings and `sound bites' appropriate for media reporting - very short presentations often presented in sets. Lightning or Ignite (20 slides @15 seconds each) and PechaKucha (20 slides @20 seconds each) presentations are common formats for short, rapid communications at scientific conferences and public events. The simple rules for making good presentations also apply, but these presentation formats provide both unique communication opportunities and novel challenges. In the spirit of light, quick, and exact (but without the fox), here are ten simple rules for presentation formats that do not wait for the speaker.

Measure Twice, Build Once: Bench-Scale Testing to Evaluate Bioretention Media Design - slides

EPA Science Inventory

The oral presentation will be at the EWRI International LID Conference in San Francisco, on April 11-14, 2010. The slides discuss the utility of conducting bench-scale testing on selected bioretention media and media amendments to validate hydrologic properties before installing...

Phytochemical characteristic and uterotonic effect of aqueous extract of Ficus deltoidea leaves in rats uterus.

PubMed

Amiera, Z Umi Romaizatul; Nihayah, M; Wahida, I Farah; Rajab, N F

2014-09-01

Ficus deltoidea is traditionally consumed by Malay woman to augment labour and hastening parturition. This study was to investigate the phytochemical present and uterotonic activity of F. deltoidea var. Deltoidea (FDD) and F. deltoidea var. Angustifolia (FDA) leaves aqueous extract. FDD and FDA were qualitatively analysed. In uterine contraction activity, adult female Sprague Dawley rats were pretreated with 0.2 mg kg(-1) diethylstilbestrol 24 h to induce oestrus phase. The rats then killed and uterine horns were taken out, cut into two centimetres length and put into organ bath that connected to Powerlab instrument. The uterus separately tested with cumulative concentrations of FDD (10-1280 μg mL(-1)), FDA (10-1280 μg mL(-1)), oxytocin (0.02-0.64 μg mL(-1)) and combination of oxytocin (0.08 μg mL(-1)) with FDD and FDA (10-1280 μg mL(-1)). FDD showed presence of flavonoid, saponin and tannin meanwhile FDA consist of flavonoid, tannin and terpenoid. Result showed FDD, FDA and oxytocin induced a dose-related increase in force of contraction of isolated rat uterus. The maximum uterine contraction (Emax) produced by FDD, FDA and oxytocin were at the concentration 640 μg mL(-1) (EC50, 5.903 ± 0.529 μg mL), 20 μg mL(-1) (EC50, 290.5 ± 0.158 μg mL(-1)) and 0.4 μg mL(-1) (EC50, 0.060 ± 0.011 μg mL(-1)) respectively. Combination effects of oxytocin with FDD and FDA produced Emax at the concentration 80 μg mL(-1) (EC50, 270.3 ± 0.643 μg mL(-1)) and 1280 μg mL(-1) (EC50, 26.83 ± 0.727 μg mL(-1)), respectively. Study indicated F. deltoidea possess contractile effect on uterine contraction. This plant has great potential to develop as natural uterotonic agent in inducing labour and treatment for post-partum haemorrhage.

21 CFR 314.102 - Communications between FDA and applicants.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...

36 CFR 13.980 - Other FDA closures and restrictions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 36 Parks, Forests, and Public Property 1 2013-07-01 2013-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...

36 CFR 13.980 - Other FDA closures and restrictions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 36 Parks, Forests, and Public Property 1 2014-07-01 2014-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...

21 CFR 314.102 - Communications between FDA and applicants.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...

FDA Kids' Home Page

MedlinePlus

... and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search Popular Content Home Food Drugs Medical ... 日本語 | فارسی | English FDA Accessibility Careers FDA Basics FOIA No FEAR Act ...

36 CFR 13.980 - Other FDA closures and restrictions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...

21 CFR 314.102 - Communications between FDA and applicants.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...

21 CFR 314.102 - Communications between FDA and applicants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...

36 CFR 13.980 - Other FDA closures and restrictions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 36 Parks, Forests, and Public Property 1 2012-07-01 2012-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...

36 CFR 13.980 - Other FDA closures and restrictions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...

21 CFR 314.102 - Communications between FDA and applicants.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...

78 FR 18233 - Medical Devices; Technical Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

... the right column: Section Remove Add 814.20 http://www.fda.gov/ http://www.fda.gov/ cdrh/devadvice.../ PremarketApproval PMA/default.htm. 822.7 http://www.fda.gov/ http://www.fda.gov/ cdrh/ombudsman/ AboutFDA/ dispute.html. CentersOffices/ OfficeofMedicalPr oductsandTobacco/ CDRH/ CDRHOmbudsman/ default.htm. 822.15...

Advanced Interval Type-2 Fuzzy Sliding Mode Control for Robot Manipulator.

PubMed

Hwang, Ji-Hwan; Kang, Young-Chang; Park, Jong-Wook; Kim, Dong W

2017-01-01

In this paper, advanced interval type-2 fuzzy sliding mode control (AIT2FSMC) for robot manipulator is proposed. The proposed AIT2FSMC is a combination of interval type-2 fuzzy system and sliding mode control. For resembling a feedback linearization (FL) control law, interval type-2 fuzzy system is designed. For compensating the approximation error between the FL control law and interval type-2 fuzzy system, sliding mode controller is designed, respectively. The tuning algorithms are derived in the sense of Lyapunov stability theorem. Two-link rigid robot manipulator with nonlinearity is used to test and the simulation results are presented to show the effectiveness of the proposed method that can control unknown system well.

Sliding enhances fluid and solute transport into buried articular cartilage contacts.

PubMed

Graham, B T; Moore, A C; Burris, D L; Price, C

2017-12-01

Solutes and interstitial water are naturally transported from cartilage by load-induced interstitial fluid pressures. Fluid and solute recovery during joint articulation have been primarily attributed to passive diffusion and mechanical 'pumping' from dynamic loading. This paper tests if the sliding action of articulation is a significant and independent driver of fluid and solute transport in cartilage. The large osteochondral samples utilized in the present study preserve the convergent wedges necessary for physiological hydrodynamics. Following static load-induced fluid exudation and prior to sliding, a fluorescent solute (AlexaFluor 633) was added to the lubricant bath. In situ confocal microscopy was used to quantify the transport of solute from the bath into the buried stationary contact area (SCA) during sliding. Following static exudation, significant reductions in friction and strain during sliding at 60 mm/s were accompanied by significant solute transport into the inaccessible center of the buried contact; no such transport was detected for the 0- or 1 mm/s sliding conditions. The results suggest that external hydrodynamic pressures from sliding induced advective flows that carried solutes from the bath toward the center of contact. These results provide the first direct evidence that the action of sliding is a significant contributor to fluid and solute recovery by cartilage. Furthermore, they indicate that the sliding-induced transport of solutes into the buried interface was orders of magnitude greater than that attributable to diffusion alone, a result with critical implications for disease prevention and tissue engineering. Copyright © 2017 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Consumer advertising of psychiatric medications biases the public against nonpharmacological treatment.

PubMed

Lacasse, Jeffrey R

2005-01-01

In the United States, antidepressant medications are heavily promoted through direct-to-consumer advertising, which is regulated by the Food and Drug Administration (FDA). Advertisements for selective serotonin reuptake inhibitors frequently contain information inconsistent with the scientific evidence on the treatment of depression with antidepressants. The information presented serves to promote the use of antidepressants by biasing the public against nonpharmacological treatment of depression. While the FDA enforces regulations requiring fair and balanced presentation when comparing one medication to another, there appears to be no action taken against pharmaceutical companies that distort scientific evidence in order to disparage nonmedical approaches to depression.

Boveri's research at the Zoological Station Naples: Rediscovery of his original microscope slides at the University of Würzburg.

PubMed

Scheer, Ulrich

2018-02-14

Eric Davidson once wrote about Theodor Boveri: "From his own researches, and perhaps most important, his generalized interpretations, derive the paradigms that underlie modern inquiries into the genomic basis of embryogenesis" (Davidson, 1985). As luck would have it, the "primary data" of Boveri's experimental work, namely the microscope slides prepared by him and his wife Marcella during several stays at the Zoological Station in Naples (1901/02, 1911/12 and 1914), have survived at the University of Würzburg. More than 600 slides exist and despite their age they are in a surprisingly good condition. The slides are labelled and dated in Boveri's handwriting and thus can be assigned to his published experimental work on sea urchin development. The results allowed Boveri to unravel the role of the cell nucleus and its chromosomes in development and inheritance. Here, I present an overview of the slides in the context of Boveri's work along with photographic images of selected specimens taken from the original slides. It is planned to examine the slides in more detail, take high-resolution focal image series of significant specimens and make them online available. Copyright © 2018 The Author. Published by Elsevier B.V. All rights reserved.

Suicidality and risk of suicide--definition, drug safety concerns, and a necessary target for drug development: a consensus statement.

PubMed

Meyer, Roger E; Salzman, Carl; Youngstrom, Eric A; Clayton, Paula J; Goodwin, Frederick K; Mann, J John; Alphs, Larry D; Broich, Karl; Goodman, Wayne K; Greden, John F; Meltzer, Herbert Y; Normand, Sharon-Lise T; Posner, Kelly; Shaffer, David; Oquendo, Maria A; Stanley, Barbara; Trivedi, Madhukar H; Turecki, Gustavo; Beasley, Charles M; Beautrais, Annette L; Bridge, Jeffrey A; Brown, Gregory K; Revicki, Dennis A; Ryan, Neal D; Sheehan, David V

2010-08-01

To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009. This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies of major depression, bipolar disorder, schizophrenia, substance abuse/dependence, and other psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest. Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted. Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this scholarly article, which has been developed by the authors with feedback from all participants at the meeting and represents a consensus view. Any areas of disagreement have been noted. The term suicidality is not as clinically useful as more specific terminology (ideation, behavior, attempts, and suicide). Most participants applauded the FDA's effort to promote standard definitions and definable expectations for investigators and industry sponsors by endorsing the terminology in the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Further research of available assessment instruments is needed to verify their utility, reliability, and validity in identifying suicide-associated treatment-emergent adverse effects and/or a signal of efficacy in suicide prevention trials. The FDA needs to build upon its new authority to systematically monitor postmarketing events by encouraging the development of a validated instrument for postmarketing surveillance of suicidal ideation, behavior, and risk within informative large health care-related databases in the United States and abroad. Over time, the FDA, industry, and clinical researchers should evaluate the impact of the current Agency requirement that all CNS clinical drug trials must include a C-CASA-compatible screening instrument for assessing and documenting the occurrence of treatment-emergent suicidal ideation and behavior. Finally, patients at high risk for suicide can safely be included in clinical trials, if proper precautions are followed, and they need to be included to enable premarket assessments of the risks and benefits of medications related to suicidal ideation, suicidal behavior, and suicide in such patients. Copyright 2010 Physicians Postgraduate Press, Inc.

Teaching Consumer Selection of Market Quality Beef by Observable Characteristics

ERIC Educational Resources Information Center

Halvorson, Dorothy; Jacobson, Marion

1977-01-01

Through a series of five tests, a slide-tape instructional presentation on the identification of beef quality was developed. It was determined that the slide-tape instruction can enable consumers to score more accurately characteristics of raw beef in relation to the characteristics of cooked beef. (Editor/TA)

Teacher's Guide to Aviation Education Resources. Including: Career Information, Audiovisuals, Publications, Periodicals.

ERIC Educational Resources Information Center

Federal Aviation Administration (DOT), Washington, DC. Office of Public Affairs.

Currently available aviation education resource materials are listed alphabetically by title under four headings: (1) career information; (2) audiovisual materials; (3) publications; and (4) periodicals. Each entry includes: title; format (16mm film, slides, slide/tape presentation, VHS/Beta videotape, book, booklet, newsletter, pamphlet, poster,…

21 CFR 1.280 - How must you submit prior notice?

Code of Federal Regulations, 2010 CFR

2010-04-01

... to FDA. You must submit all prior notice information in the English language, except that an... Commercial System (ABI/ACS); or (2) The FDA PNSI at http://www.access.fda.gov. You must submit prior notice through the FDA Prior Notice System Interface (FDA PNSI) for articles of food imported or offered for...

78 FR 65329 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... Safety Testing of Sunlamp Products'' Form FDA 3632 ``Guide for Preparing Product Reports on Lasers and Products Containing Lasers'' Form FDA 3633''General Variance Request'' Form FDA 3634 ``Television Products Annual Report'' Form FDA 3635 ``Laser Light Show Notification'' Form FDA 3636 ``Guide for Preparing...

78 FR 35279 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-12

... Lasers and Products Containing Lasers'' FDA Form 3633 ``General Variance Request'' FDA Form 3634 ``Television Products Annual Report'' FDA Form 3635 ``Laser Light Show Notification'' FDA Form 3636 ``Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products'' FDA Form 3637...

75 FR 26964 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-13

... of Sunlamps and Sunlamp Products'' FDA Form 3632 ``Guide for Preparing Product Reports on Lasers and Products Containing Lasers'' FDA Form 3633 ``General Variance Request'' FDA Form 3634 ``Television Products Annual Report'' FDA Form 3635 ``Laser Light Show Notification'' FDA Form 3636 ``Guide for Preparing...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

21 CFR 314.106 - Foreign data.

Code of Federal Regulations, 2012 CFR

2012-04-01

... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...

21 CFR 314.106 - Foreign data.

Code of Federal Regulations, 2013 CFR

2013-04-01

... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 2 2014-10-01 2014-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

21 CFR 314.106 - Foreign data.

Code of Federal Regulations, 2010 CFR

2010-04-01

... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 2 2013-10-01 2013-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

21 CFR 314.106 - Foreign data.

Code of Federal Regulations, 2011 CFR

2011-04-01

... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...

21 CFR 314.106 - Foreign data.

Code of Federal Regulations, 2014 CFR

2014-04-01

... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 2 2011-10-01 2011-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 2 2012-10-01 2012-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0792] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance...

21 CFR 830.100 - FDA accreditation of an issuing agency.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA accreditation of an issuing agency. 830.100... (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA Accreditation of an Issuing Agency § 830.100 FDA... issuing agency. (b) Accreditation criteria. FDA may accredit an organization as an issuing agency, if the...

International Space Agency CIO Forum Industrial Control System (ICS) and Cyber

NASA Technical Reports Server (NTRS)

Powell, Robert

2017-01-01

This briefing covers Industrial Control System (ICS) best practices for enhancing cyber protection. The briefing provides a very high-level overview of best practices currently being pursued by NASA as well as by other US government agencies such as NIST and DHS ICS-CERT. All information presented in this slide deck is publicly available and no sensitive information is provided in these slides. These slides will be used to generate discussion around best practices within the international community in the area of ICS cyber protections.

Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.

PubMed

Sage, Adam; Blalock, Susan J; Carpenter, Delesha

This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications. Copyright © 2016 Elsevier Inc. All rights reserved.

Determination of radionuclides in foods from Minsk, Belarus, from Chernobyl to the present

NASA Astrophysics Data System (ADS)

Baratta, E. J.

2003-01-01

The U.S. Food and Drug Administration (FDA) are responsible for the wholesomeness of the food supply in the United States (US). The FDA has been monitoring the food supply in the United States for radioactivity since 1961, because of the Fallout generated by above the ground testing in the early 60’s. This Radionuclide in Foods Program is maintained to allow the FDA to respond to any nuclear emergency that may affect the food supply. The Three Mile Island incident in 1979 was one of these. In 1986 the Chernobyl incident occurred. As a result, the FDA began extensive monitoring of imported foods, especially those from Europe. One of its sister agencies has personnel in the areas effected by the latter incident and requested that the FDA analyze selected food samples from these places. Since that time, they have requested on a periodic basis, selected food samples be analysed. One such city was Minsk in Belarus. This paper will discuss the radionuclides of interest such as iodine-131, cesium-134/137, strontium-90, ruthenium-106 and other short-lived ones. It will discuss the types of foods sampled and the methodology used in determining the concentrations found in these items. The results will be compared to the permissible levels allowed in the US. In addition it will show the lower limits of detection for each of the radionuclides of interest.

The frequency response of dynamic friction: Enhanced rate-and-state models

NASA Astrophysics Data System (ADS)

Cabboi, A.; Putelat, T.; Woodhouse, J.

2016-07-01

The prediction and control of friction-induced vibration requires a sufficiently accurate constitutive law for dynamic friction at the sliding interface: for linearised stability analysis, this requirement takes the form of a frictional frequency response function. Systematic measurements of this frictional frequency response function are presented for small samples of nylon and polycarbonate sliding against a glass disc. Previous efforts to explain such measurements from a theoretical model have failed, but an enhanced rate-and-state model is presented which is shown to match the measurements remarkably well. The tested parameter space covers a range of normal forces (10-50 N), of sliding speeds (1-10 mm/s) and frequencies (100-2000 Hz). The key new ingredient in the model is the inclusion of contact stiffness to take into account elastic deformations near the interface. A systematic methodology is presented to discriminate among possible variants of the model, and then to identify the model parameter values.

Laboratory Testing of Donors and Stool Samples for Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection

PubMed Central

Neish, Emma M.; Miller, Nancy S.; Dhere, Tanvi; Burd, Eileen M.; Carpentieri, Cynthia; Sitchenko, Kaitlin L.

2017-01-01

ABSTRACT Fecal microbiota transplantation is an efficacious and inexpensive therapy for recurrent Clostridium difficile infection, yet its safety is thought to depend on appropriate fecal donor screening. FDA guidance for regulation of this procedure is in flux, but screening and manufacture of fecal material from asymptomatic donors present many challenges to clinical laboratories. This minireview summarizes FDA regulatory changes, principles of donor selection, and recommended laboratory screening practices for fecal microbiota transplantation. PMID:28077694

21 CFR 14.15 - Committees working under a contract with FDA.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...

21 CFR 14.15 - Committees working under a contract with FDA.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...

77 FR 52036 - Privacy Act of 1974; Report of a New System of Records; FDA Records Related to Research...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0253] Privacy Act of 1974; Report of a New System of Records; FDA Records Related to Research Misconduct... Drug Administration's (FDA's) regulations for the protection of privacy, FDA is publishing notice of a...

21 CFR 14.15 - Committees working under a contract with FDA.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...

21 CFR 60.34 - FDA action on petitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...

21 CFR 60.34 - FDA action on petitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...

21 CFR 60.34 - FDA action on petitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...

21 CFR 60.34 - FDA action on petitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...

21 CFR 14.15 - Committees working under a contract with FDA.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...

21 CFR 14.15 - Committees working under a contract with FDA.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...

21 CFR 830.220 - Termination of FDA service as an issuing agency.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Termination of FDA service as an issuing agency... SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA as an Issuing Agency § 830.220 Termination of FDA service as an issuing agency. (a) FDA may end our services as an issuing agency if we...

21 CFR 60.34 - FDA action on petitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...

[Virtual microscopy in pathology teaching and postgraduate training (continuing education)].

PubMed

Sinn, H P; Andrulis, M; Mogler, C; Schirmacher, P

2008-11-01

As with conventional microscopy, virtual microscopy permits histological tissue sections to be viewed on a computer screen with a free choice of viewing areas and a wide range of magnifications. This, combined with the possibility of linking virtual microscopy to E-Learning courses, make virtual microscopy an ideal tool for teaching and postgraduate training in pathology. Uses of virtual microscopy in pathology teaching include blended learning with the presentation of digital teaching slides in the internet parallel to presentation in the histology lab, extending student access to histology slides beyond the lab. Other uses are student self-learning in the Internet, as well as the presentation of virtual slides in the classroom with or without replacing real microscopes. Successful integration of virtual microscopy depends on its embedding in the virtual classroom and the creation of interactive E-learning content. Applications derived from this include the use of virtual microscopy in video clips, podcasts, SCORM modules and the presentation of virtual microscopy using interactive whiteboards in the classroom.

Indian sports nicknames/logos: affective difference between American Indian and non-Indian college students.

PubMed

LaRocque, Angela R; McDonald, J Douglas; Weatherly, Jeffrey N; Ferraro, F Richard

2011-01-01

The use of American Indian (AI) words and images in athletic teams' nicknames, logos, and mascots remains a controversial issue. This study investigated the emotional impact of the University of North Dakota's "Fighting Sioux" nickname/logo on 33 AI and 36 majority culture (MC) students enrolled at the university. Participants completed the Multiple Affect Adjective Checklist-Revised (MAACL-R) before viewing two slide presentations of Fighting Sioux-related images: one neutral (i.e., non-controversial) and one controversial. Participants completed the MAACL-R after each presentation. They also completed the Nickname and Logo Distress Scale, and AI participants completed the Northern Plains Biculturalism Inventory to assess their degree of cultural orientation. Results showed that AIs experienced higher negative affect following both slide presentations than did MC participants. MC participants' affect was only changed following the controversial slide presentation. The findings suggest AI students may experience significantly higher levels of psychological distress when viewing even neutral images of AI nicknames/logos.

FDA Warns About Stem Cell Therapies

MedlinePlus

... For Consumers Consumer Updates FDA Warns About Stem Cell Therapies Share Tweet Linkedin Pin it More sharing ... the boxed section below for more advice. Stem Cell Uses and FDA Regulation The FDA has the ...

Tribological evaluation of PS300: A new chrome oxide based solid lubricant coating sliding against Al2O3 From 25 to 650 C

NASA Technical Reports Server (NTRS)

DellaCorte, C.; Laskowski, J. A.

1996-01-01

This paper presents the tribological characteristics of Al203 sliding against PS300; a chrome oxide based self lubricating coating. Al203 pins were slid against PS300 coated superalloy disks in air, under a 4.9 N load at velocities of 1 to 8 m/s. At a sliding velocity of 1 m/s, friction ranged from 0.6 at 25 C to 0.2 at 650 C. Wear factors for the Al203 pins were in the 10(exp -7) mm(exp 3)/N-m range and for the PS300 coating was in the 10(exp -5) mm(exp 3)/N-m range. The test results suggest that increased surface temperature resulting from either frictional heating, generated by increased sliding velocity, or ambient heating caused a reduction in friction and wear of the sliding couple. Based upon these results, the tested material combination is a promising candidate for high temperature wear applications.

Studies on allergenic algae of Delhi area: botanical aspects.

PubMed

Mittal, A; Agarwal, M K; Shivpuri, D N

1979-04-01

To study distribution of algae in and around Delhi aerobiological surveys were undertaken for two consecutive years (September, 1972, to August, 1974). The surveys were accomplished by (a) slide exposure method and (b) culture plate exposure method. A total of 850 slides were exposed using Durham's gravity sampling device. Of these, 560 slides were exposed during 1973 (272 slides at two meter and 288 at ten meter height) and the rest (290 slides) were exposed during 1974 at ten meter height. A total of 858 culture plates were exposed (276 for one hour and 282 for two hours) during 1973 and the rest (300 culture plates) were exposed during 1974 at ten meter height for two hours duration only. Air was found to be rich in algae flora during the months of September to November. The dominant forms of algae present were all blue greens. This might be due to the relative greater resistance of blue green algae to unfavorable conditions.

Wear of liquid nitrogen-cooled 440C bearing steels in an oxygen environment

NASA Technical Reports Server (NTRS)

Chaudhuri, Dilip K.; Verma, Ravi

1988-01-01

This paper presents up-to-date findings of the research being conducted to understand the mechanism of sliding wear in unlubricated 440C bearing steels under oxidative conditions. A sliding wear test rig has been designed and built with a cylinder-on-flat geometry. The equipment is capable of testing specimens under high axial loads and sliding speeds in a simulated LOX environment. Samples of 440C steel, quenched and tempered to a hardness of Rc 56, were tested under a load of 890 N and a sliding speed of 2.05 m/sec for total sliding distances of up to 5.54 km. Flash temperatures during these tests were measured with an IR camera and a fast digital recorder. Microstructural and microanalytical data from the worn surfaces and the debris particles are analyzed extensively, along with wear rates, flash temperatures, surface profiles, hardnesses, and residual stresses, in the context of oxidation and wear theories.

Why (not) go east? Comparison of findings from FDA Investigational New Drug study site inspections performed in Central and Eastern Europe with results from the USA, Western Europe, and other parts of the world.

PubMed

Caldron, Paul H; Gavrilova, Svetlana I; Kropf, Siegfried

2012-01-01

Since the mid-1990s, investigational sites in the countries of Central and Eastern Europe (CEE) have been increasingly utilized by pharmaceutical companies because of their high productivity in terms of patient enrolment into clinical trials. Based on the FDA's publicly accessible Clinical Investigator Inspection List, we present an analysis of findings and outcome classifications from FDA inspections during Investigational New Drug (IND) studies and compare the results for the CEE region to those from Western European countries and the USA. Data from all 5531 FDA clinical trials inspections that occurred between 1994 (when the FDA first performed inspections in CEE) and the end of 2010 were entered into the database for comparative analysis. Of these, 4865 routine data audit (DA) inspections were analyzed: 401 from clinical trials performed in Western Europe, 230 in CEE, 3858 in the USA, and 376 in other countries. The average number of deficiencies per inspection ranged between 0.99 for CEE and 1.97 in Western Europe. No deficiencies were noted during 16.6%, 39.0%, and 21.5% of the inspections in Western Europe, CEE and USA, respectively. The percentages of inspections after which no follow-up action was indicated were 36.9% for Western Europe, 55.7% for CEE, and 44.3% for US sites. CEE was also the region with the lowest percentage of inspections that required official or voluntary action. On the basis of FDA inspection data, the high productivity of CEE sites appears to be accompanied by regulatory compliance as well as by data quality standards that are not inferior to those in Western regions.

Smokers' attitudes and support for e-cigarette policies and regulation in the USA.

PubMed

Wackowski, Olivia A; Delnevo, Cristine D

2015-11-01

In April 2014, the Food and Drug Administration (FDA) proposed a rule to extend its tobacco regulatory authority to e-cigarettes, which have been unregulated and growing in use since their 2006-2007 US introduction. The FDA will issue a final rule based on comments and data received from researchers, tobacco companies and the public. We aimed to present data about current smokers' awareness of and attitudes towards potential e-cigarette regulation and various policies in the USA. We conducted a cross-sectional online e-cigarette focused survey of 519 adult current smokers in April 2014, before the FDA's proposed rule was announced. Participants were recruited from a private research panel (GFK's Knowledge Networks) designed to be representative of the US population. The majority of respondents (62.5%) did not know that e-cigarettes are unregulated by the FDA but agreed that e-cigarettes should be regulated by the FDA for safety and quality (83.5%), carry warning labels about their potential risks (86.6%) and have the same legal age of sale as other tobacco (87.7%). Support was similarly high among current e-cigarette users. Support was substantial though lower overall for policies to restrict e-cigarette indoor use (41.2%), flavouring (44.3%) and advertising (55.5%), and was negatively associated with current e-cigarette use. Support for many e-cigarette regulatory policies is strong among smokers, including for policies that the FDA has recently proposed and potential future regulations. States considering indoor e-cigarette restrictions should know that a substantial number of current smokers support such regulations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Review of Usnic Acid and Usnea Barbata Toxicity

PubMed Central

Guo, Lei; Shi, Qiang; Fang, Jia-Long; Mei, Nan; Ali, A. Afshan; Lewis, Sherry M.; Leakey, Julian E.A.; Frankos, Vasilios H.

2017-01-01

Usnic acid is a prominent secondary lichen metabolite that has been used for various purposes worldwide. Crude extracts of usnic acid or pure usnic acid have been marketed in the United States as dietary supplements to aid in weight loss. The US Food and Drug Administration (FDA) received 21 reports of liver toxicity related to the ingestion of dietary supplements that contain usnic acid. This prompted the FDA to issue a warning about one such supplement, LipoKinetix, in 2001 (http://www.cfsan.fda.gov/~dms/ds-lipo.html). Subsequently, usnic acid and Usnea barbata lichen were nominated by the National Toxicology Program (NTP) for toxicity evaluations. At present, a toxicological evaluation of usnic acid is being conducted by the NTP. This review focuses on the recent findings of usnic acid-induced toxicities and their underlying mechanisms of action. PMID:19034791

Fabrication of 6FDA-durene membrane incorporated with zeolite T and aminosilane grafted zeolite T for CO2/CH4 separation

NASA Astrophysics Data System (ADS)

Jusoh, Norwahyu; Fong Yeong, Yin; Keong Lau, Kok; Shariff, Azmi Mohd

2017-08-01

In the present work, zeolite T and aminosilane grafted zeolite T are embedded into 6FDA-durene polyimide phase for the fabrication of mixed matrix membranes (MMMs). FESEM images demonstrated that the improvement of interfacial adhesion between zeolite and polymer phases in MMM loaded with aminosilane grafted zeolite T was not significant as compared to zeolite T/6FDA-durene MMM. From the gas permeation test, CO2/CH4 selectivity up to 26.4 was achieved using MMM containing aminosilane grafted zeolite T, while MMM loaded with ungrafted zeolite T showed CO2/CH4 selectivity of 19.1. In addition, MMM incorporated with aminosilane grafted zeolite T particles successfully lies on Robeson upper bound 2008, which makes it an attractive candidate for CO2/CH4 separation.

Whole slide imaging of unstained tissue using lensfree microscopy

NASA Astrophysics Data System (ADS)

Morel, Sophie Nhu An; Hervé, Lionel; Bordy, Thomas; Cioni, Olivier; Delon, Antoine; Fromentin, Catherine; Dinten, Jean-Marc; Allier, Cédric

2016-04-01

Pathologist examination of tissue slides provides insightful information about a patient's disease. Traditional analysis of tissue slides is performed under a binocular microscope, which requires staining of the sample and delays the examination. We present a simple cost-effective lensfree imaging method to record 2-4μm resolution wide-field (10 mm2 to 6 cm2) images of unstained tissue slides. The sample processing time is reduced as there is no need for staining. A wide field of view (10 mm2) lensfree hologram is recorded in a single shot and the image is reconstructed in 2s providing a very fast acquisition chain. The acquisition is multispectral, i.e. multiple holograms are recorded simultaneously at three different wavelengths, and a dedicated holographic reconstruction algorithm is used to retrieve both amplitude and phase. Whole tissue slides imaging is obtained by recording 130 holograms with X-Y translation stages and by computing the mosaic of a 25 x 25 mm2 reconstructed image. The reconstructed phase provides a phase-contrast-like image of the unstained specimen, revealing structures of healthy and diseased tissue. Slides from various organs can be reconstructed, e.g. lung, colon, ganglion, etc. To our knowledge, our method is the first technique that enables fast wide-field lensfree imaging of such unlabeled dense samples. This technique is much cheaper and compact than a conventional phase contrast microscope and could be made portable. In sum, we present a new methodology that could quickly provide useful information when a rapid diagnosis is needed, such as tumor margin identification on frozen section biopsies during surgery.

Push-out tests on a new silicon carbide/reaction-bonded silicon carbide ceramic matrix composite

NASA Technical Reports Server (NTRS)

Curtin, William A.; Eldridge, Jeffrey I.; Srinivasan, Gajawalli V.

1993-01-01

Fiber push-out tests have been performed on a ceramic matrix composite consisting of carborundum-sintered SiC fibers, with a BN coating, embedded in a reaction-bonded SiC matrix. Analysis of the push-out data, utilizing the most complete theory presently available, shows that one of the fiber/coating/matrix interfaces has a low fracture energy (one-tenth that of the fiber) and a moderate sliding resistance of about 8 MPa. The debonded sliding interface shows some continuous but minor abrasion, which appears to increase the sliding resistance, but overall the system exhibits very clean smooth sliding. The tensile response of a full-scale composite is then modeled using data obtained here and known fiber strengths to demonstrate the good composite behavior predicted for this material.

Science documentary video slides to enhance education and communication

NASA Astrophysics Data System (ADS)

Byrne, J. M.; Little, L. J.; Dodgson, K.

2010-12-01

Documentary production can convey powerful messages using a combination of authentic science and reinforcing video imagery. Conventional documentary production contains too much information for many viewers to follow; hence many powerful points may be lost. But documentary productions that are re-edited into short video sequences and made available through web based video servers allow the teacher/viewer to access the material as video slides. Each video slide contains one critical discussion segment of the larger documentary. A teacher/viewer can review the documentary one segment at a time in a class room, public forum, or in the comfort of home. The sequential presentation of the video slides allows the viewer to best absorb the documentary message. The website environment provides space for additional questions and discussion to enhance the video message.

Multi-mode sliding mode control for precision linear stage based on fixed or floating stator.

PubMed

Fang, Jiwen; Long, Zhili; Wang, Michael Yu; Zhang, Lufan; Dai, Xufei

2016-02-01

This paper presents the control performance of a linear motion stage driven by Voice Coil Motor (VCM). Unlike the conventional VCM, the stator of this VCM is regulated, which means it can be adjusted as a floating-stator or fixed-stator. A Multi-Mode Sliding Mode Control (MMSMC), including a conventional Sliding Mode Control (SMC) and an Integral Sliding Mode Control (ISMC), is designed to control the linear motion stage. The control is switched between SMC and IMSC based on the error threshold. To eliminate the chattering, a smooth function is adopted instead of a signum function. The experimental results with the floating stator show that the positioning accuracy and tracking performance of the linear motion stage are improved with the MMSMC approach.

77 FR 16973 - Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-23

...The Food and Drug Administration (FDA) is reopening the comment period on specific data related to a proposed rule published in the Federal Register of March 29,, to establish standards that would be considered in determining whether the major statement in direct-to- consumer (DTC) television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner. In the Federal Register of January 27, 2012, FDA announced that it had added a document to the docket for the proposed rulemaking concerning a study entitled ``Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements'' (Distraction Study) and the public was given until February 27, 2012, to comment on this study as it relates to the proposed standards. FDA is reopening the comment period for the rulemaking proceeding in response to a request for more time to submit comments to the Agency.

Environmental Impact Analysis Process. Environmental Assessment for Defense Satellite Communications System III With Integrated Apogee Boost System

DTIC Science & Technology

1995-07-01

spectabilis Royal fern C FDA n/o Remirea maritima Beach star E FDA, FNAI o Scaevola plumeria Scaevola T FDA o Tillandsia simulata Wildpine; air plant...unnamed) T FDA n/o Tillandsia utriculata Giant wildpine; giant air plant C FDA o 1 E = Endangered; T = Threatened; T(S/A) = Threatened due to

21 CFR 1.393 - What information must FDA include in the detention order?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...

21 CFR 1.393 - What information must FDA include in the detention order?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...

45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

Code of Federal Regulations, 2014 CFR

2014-10-01

... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare Department... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...

21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...

21 CFR 1.393 - What information must FDA include in the detention order?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...

21 CFR 830.210 - Eligibility for use of FDA as an issuing agency.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Eligibility for use of FDA as an issuing agency... SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA as an Issuing Agency § 830.210 Eligibility for use of FDA as an issuing agency. When FDA acts as an issuing agency, any labeler will be...

21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...

21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...

21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...

45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

Code of Federal Regulations, 2013 CFR

2013-10-01

... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...

21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...

21 CFR 1.393 - What information must FDA include in the detention order?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...

45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

Code of Federal Regulations, 2012 CFR

2012-10-01

... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...

45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

Code of Federal Regulations, 2010 CFR

2010-10-01

... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...

45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

Code of Federal Regulations, 2011 CFR

2011-10-01

... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...

21 CFR 1.393 - What information must FDA include in the detention order?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...

Non-Ionizing Radiation Used in Microwave Ovens

MedlinePlus

... Human Services (HHS), U.S. Food and Drug Administration (FDA) FDA's Center for Devices and Radiological Health (CDRH) sets ... public health. These standards can be viewed on FDA's Code of Federal Regulations on Microwave Ovens . FDA ...

Sensing our air: the quest for big data about our air quality

EPA Science Inventory

These slides will be presented as part of a panel session at the GovLoop virtual training session on innovation in the government, with the panel session topic focusing on big data and emerging "internet of things". The slides are to provide some background and raise a few topic...

Pre-Class Coming Attractions: Interest and Program Awareness in the Classroom

ERIC Educational Resources Information Center

Nadler, Joel T.; Clark, M. H.

2010-01-01

Slides similar to "Coming Attractions" shown in cinemas were displayed prior to classes at a mid-western university over three semesters. More than 140 PowerPoint slides, featuring humor, psychology content, and department/faculty information were presented immediately prior to undergraduate psychology class lectures. The primary goals were to…

Flight Control Design for an Autonomous Rotorcraft Using Pseudo-Sliding Mode Control and Waypoint Navigation

NASA Astrophysics Data System (ADS)

Mallory, Nicolas Joseph

The design of robust automated flight control systems for aircraft of varying size and complexity is a topic of continuing interest for both military and civilian industries. By merging the benefits of robustness from sliding mode control (SMC) with the familiarity and transparency of design tradeoff offered by frequency domain approaches, this thesis presents pseudo-sliding mode control as a viable option for designing automated flight control systems for complex six degree-of-freedom aircraft. The infinite frequency control switching of SMC is replaced, by necessity, with control inputs that are continuous in nature. An introduction to SMC theory is presented, followed by a detailed design of a pseudo-sliding mode control and automated flight control system for a six degree-of-freedom model of a Hughes OH6 helicopter. This model is then controlled through three different waypoint missions that demonstrate the stability of the system and the aircraft's ability to follow certain maneuvers despite time delays, large changes in model parameters and vehicle dynamics, actuator dynamics, sensor noise, and atmospheric disturbances.

The virtual case: a new method to completely digitize cytological and histological slides.

PubMed

Demichelis, F; Barbareschi, M; Dalla Palma, P; Forti, S

2002-08-01

The purpose of this study was to present a new method for handling histological/cytological cases. Thanks to the introduction of information technology in pathology, including the amenities afforded by robotic microscopes and digital imaging, tissue slides can be represented and evaluated using digital techniques in order to construct virtual cases through completely automated procedures. A virtual case (VC) is composed of a collection of digital images representing a histological/cytological slide at all magnification levels together with all relevant clinical data. In the present study, we describe an automated system to manage robotic microscope and image acquisition for the proper construction of VCs. These can then be viewed on a computer by means of an interface ("user-friendly") that allows one to select the more appropriate fields and to examine them at different magnifications, rapidly going from panoramic views to high resolution and vice versa. In comparison with glass slides, VCs have several advantages arising from their digital nature and can be considered a common platform for a wide range of applications such as teleconsultation, education, research, and quality control and proficiency tests.

Research on some auxiliary mechanisms used in passenger cars

NASA Astrophysics Data System (ADS)

Antonescu, Daniela; Iozsa, Daniel; Antonescu, Ovidiu; Fratila, Gh.

2017-10-01

The paper presents the results of researches on the topological structure and geometrical analysis of the planar mechanisms with articulated bars, which are used for actuating the doors of cars. The main five types of car doors with rotate movement (folding) are presented, being described both as constructive structure and mode of operation, through suitable kinematic schemes. Some innovative solutions for vehicle door actuating mechanisms aim to use as little space as possible, which is beneficial for car parking. There are three types of car door movements: rotation, sliding and planar rotational-sliding. Most of the cars are equipped with folding doors, where the rotate movement is limited and operates horizontally. Almost all sliding doors are placed on the rear of the car (only for passengers, not for driver). Unlike rotate doors, the sliding doors require a minimum lateral space, which is an advantage, especially in parking places. In the end of the paper, a kinematic analysis of the canopy 4-bar mechanism has been performed, in order to increase the passenger comfort on the access into the vehicle.

Flux of Kilogram-sized Meteoroids from Lunar Impact Monitoring. Supplemental Movies

NASA Technical Reports Server (NTRS)

Suggs, Robert; Cooke, William; Suggs, Ron; McNamara, Heather; Swift, Wesley; Moser, Danielle; Diekmann, Anne

2008-01-01

These videos, and audio accompany the slide presentation "Flux of Kilogram-sized Meteoroids from Lunar Impact Monitoring." The slide presentation reviews the routine lunar impact monitoring that has harvested over 110 impacts in 2 years of observations using telescopes and low-light level video cameras. The night side of the lunar surface provides a large collecting area for detecting these impacts and allows estimation of the flux of meteoroids down to a limiting luminous energy.

An Approach to the Classification of Potential Reserve Additions of Giant Oil Fields of the World

USGS Publications Warehouse

Klett, T.R.; Tennyson, Marilyn E.

2008-01-01

This report contains slides and notes for slides for a presentation given to the Committee on Sustainable Energy and the Ad Hoc Group of Experts on Harmonization of Fossil Energy and Mineral Resources Terminology on 17 October 2007 in Geneva, Switzerland. The presentation describes the U.S. Geological Survey study to characterize and quantify petroleum-reserve additions, and the application of this study to help classify the quantities.

OpenFDA: an innovative platform providing access to a wealth of FDA's publicly available data.

PubMed

Kass-Hout, Taha A; Xu, Zhiheng; Mohebbi, Matthew; Nelsen, Hans; Baker, Adam; Levine, Jonathan; Johanson, Elaine; Bright, Roselie A

2016-05-01

The objective of openFDA is to facilitate access and use of big important Food and Drug Administration public datasets by developers, researchers, and the public through harmonization of data across disparate FDA datasets provided via application programming interfaces (APIs). Using cutting-edge technologies deployed on FDA's new public cloud computing infrastructure, openFDA provides open data for easier, faster (over 300 requests per second per process), and better access to FDA datasets; open source code and documentation shared on GitHub for open community contributions of examples, apps and ideas; and infrastructure that can be adopted for other public health big data challenges. Since its launch on June 2, 2014, openFDA has developed four APIs for drug and device adverse events, recall information for all FDA-regulated products, and drug labeling. There have been more than 20 million API calls (more than half from outside the United States), 6000 registered users, 20,000 connected Internet Protocol addresses, and dozens of new software (mobile or web) apps developed. A case study demonstrates a use of openFDA data to understand an apparent association of a drug with an adverse event. With easier and faster access to these datasets, consumers worldwide can learn more about FDA-regulated products. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved.

21 CFR 1.391 - Who approves a detention order?

Code of Federal Regulations, 2013 CFR

2013-04-01

... Fda Order A Detention? § 1.391 Who approves a detention order? An authorized FDA representative, i.e., the FDA District Director in whose district the article of food involved is located or an FDA official...

FDA Issues Final Guidance Clarifying FDA and EPA Jurisdiction over Mosquito-Related Products

EPA Pesticide Factsheets

FDA finalized guidance to provide information on FDA and EPA jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those products intended to function as pesticides

21 CFR 1.391 - Who approves a detention order?

Code of Federal Regulations, 2011 CFR

2011-04-01

... Fda Order A Detention? § 1.391 Who approves a detention order? An authorized FDA representative, i.e., the FDA District Director in whose district the article of food involved is located or an FDA official...

21 CFR 1.391 - Who approves a detention order?

Code of Federal Regulations, 2010 CFR

2010-04-01

... Fda Order A Detention? § 1.391 Who approves a detention order? An authorized FDA representative, i.e., the FDA District Director in whose district the article of food involved is located or an FDA official...

21 CFR 1.391 - Who approves a detention order?

Code of Federal Regulations, 2012 CFR

2012-04-01

... Fda Order A Detention? § 1.391 Who approves a detention order? An authorized FDA representative, i.e., the FDA District Director in whose district the article of food involved is located or an FDA official...

21 CFR 1.379 - How long may FDA detain an article of food?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional 10...

21 CFR 1.379 - How long may FDA detain an article of food?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional 10...

21 CFR 1.379 - How long may FDA detain an article of food?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional 10...

21 CFR 1.379 - How long may FDA detain an article of food?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional 10...

21 CFR 1.379 - How long may FDA detain an article of food?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional 10...

Accepted standards on how to give a Medical Research Presentation: a systematic review of expert opinion papers.

PubMed

Blome, Christine; Sondermann, Hanno; Augustin, Matthias

2017-01-01

Background: This systematic review aimed to extract recommendations from expert opinion articles on how to give a medical research presentation on a scientific conference and to determine whether the experts agree on what makes an effective or poor presentation. Methods: Presentation-related terms were searched within article titles listed in PubMed, restricting the search to English-language articles published from January 1975 to July 2015. Recommendations were extracted from the articles, grouped by content, and analyzed for frequency. Ninety-one articles were included. Among 679 different recommendations, 29 were given in more than 20% of articles each. The five most frequent recommendations were to keep slides simple, adjust the talk to the audience, rehearse, not read the talk from slides or a manuscript, and make eye contact. Results: No article gave advice that was the complete opposite of the 29 most frequent recommendations with the exception of whether a light or dark background should be used for slides. Conclusions: Researchers should comply with these widely accepted standards to be perceived as effective presenters.

Accepted standards on how to give a Medical Research Presentation: a systematic review of expert opinion papers

PubMed Central

Blome, Christine; Sondermann, Hanno; Augustin, Matthias

2017-01-01

Background: This systematic review aimed to extract recommendations from expert opinion articles on how to give a medical research presentation on a scientific conference and to determine whether the experts agree on what makes an effective or poor presentation. Methods: Presentation-related terms were searched within article titles listed in PubMed, restricting the search to English-language articles published from January 1975 to July 2015. Recommendations were extracted from the articles, grouped by content, and analyzed for frequency. Ninety-one articles were included. Among 679 different recommendations, 29 were given in more than 20% of articles each. The five most frequent recommendations were to keep slides simple, adjust the talk to the audience, rehearse, not read the talk from slides or a manuscript, and make eye contact. Results: No article gave advice that was the complete opposite of the 29 most frequent recommendations with the exception of whether a light or dark background should be used for slides. Conclusions: Researchers should comply with these widely accepted standards to be perceived as effective presenters. PMID:28293678

The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

PubMed

Ciociola, Arthur A; Karlstadt, Robyn G; Pambianco, Daniel J; Woods, Karen L; Ehrenpreis, Eli D

2014-10-01

Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.

Patient Experience Data in US Food and Drug Administration (FDA) Regulatory Decision Making:: A Policy Process Perspective.

PubMed

Kuehn, Carrie M

2018-01-01

The influence of patient advocates on FDA regulatory decision making has increased. Despite enhanced engagement with FDA, there remain challenges to achieving the regulatory goals of patients within FDA's regulatory framework. Gaps exist between patient advocates' knowledge of the agency's processes and FDA's need for rigorous, clinically meaningful patient experience data. This study examined the policy process in which patient experience data are collected by patient advocates and provided to FDA for regulatory decision making. Semistructured, narrative interviews were conducted with 14 professionals working in patient advocacy or at FDA. The purpose was to examine, in depth, participants' perceptions and experiences regarding this new regulatory process. Interviews were coded and examined for themes. The use of patient experience data by FDA is an evolving regulatory process. Participants identified a number of barriers and contributors to regulatory success. Well-organized and sophisticated patient advocacy groups with access to scientific and policy expertise are more likely to find success meeting FDA's patient experience data requirements. A conceptual model of this regulatory process was developed. Use of patient experience data by FDA has the potential to positively influence the regulation of medical products in the United States. Success within this new regulatory process will depend on clear guidance from FDA regarding the collection, analysis, and use of patient experience data. Patient advocacy groups must enhance internal capacity and expertise while engaging in substantive collaborations with FDA and other stakeholders in order to meaningfully contribute to the regulatory review of new therapeutics.

Optimizing Frozen Sample Preparation for Laser Microdissection: Assessment of CryoJane Tape-Transfer System®

PubMed Central

Golubeva, Yelena G.; Smith, Roberta M.; Sternberg, Lawrence R.

2013-01-01

Laser microdissection is an invaluable tool in medical research that facilitates collecting specific cell populations for molecular analysis. Diversity of research targets (e.g., cancerous and precancerous lesions in clinical and animal research, cell pellets, rodent embryos, etc.) and varied scientific objectives, however, present challenges toward establishing standard laser microdissection protocols. Sample preparation is crucial for quality RNA, DNA and protein retrieval, where it often determines the feasibility of a laser microdissection project. The majority of microdissection studies in clinical and animal model research are conducted on frozen tissues containing native nucleic acids, unmodified by fixation. However, the variable morphological quality of frozen sections from tissues containing fat, collagen or delicate cell structures can limit or prevent successful harvest of the desired cell population via laser dissection. The CryoJane Tape-Transfer System®, a commercial device that improves cryosectioning outcomes on glass slides has been reported superior for slide preparation and isolation of high quality osteocyte RNA (frozen bone) during laser dissection. Considering the reported advantages of CryoJane for laser dissection on glass slides, we asked whether the system could also work with the plastic membrane slides used by UV laser based microdissection instruments, as these are better suited for collection of larger target areas. In an attempt to optimize laser microdissection slide preparation for tissues of different RNA stability and cryosectioning difficulty, we evaluated the CryoJane system for use with both glass (laser capture microdissection) and membrane (laser cutting microdissection) slides. We have established a sample preparation protocol for glass and membrane slides including manual coating of membrane slides with CryoJane solutions, cryosectioning, slide staining and dissection procedure, lysis and RNA extraction that facilitated efficient dissection and high quality RNA retrieval from CryoJane preparations. CryoJane technology therefore has the potential to facilitate standardization of laser microdissection slide preparation from frozen tissues. PMID:23805281

Role of gas hydrates in slope failure on frontal ridge of northern Cascadia margin

NASA Astrophysics Data System (ADS)

Yelisetti, Subbarao; Spence, George D.; Riedel, Michael

2014-10-01

Several slope failures are observed near the deformation front on the frontal ridges of the northern Cascadia accretionary margin off Vancouver Island. The cause for these events is not clear, although several lines of evidence indicate a possible connection between the occurrence of gas hydrate and submarine landslide features. The presence of gas hydrate is indicated by a prominent bottom-simulating reflector (BSR), at a depth of ˜265-275 m beneath the seafloor (mbsf), as interpreted from vertical-incidence and wide-angle seismic data beneath the ridge crests of the frontal ridges. For one slide, informally called Slipstream Slide, the velocity structure inferred from tomography analyses shows anomalous high velocities values of about 2.0 km s-1 at shallow depths of 100 mbsf. The estimated depth of the glide plane (100 ± 10 m) closely matches the depth of these shallow high velocities. In contrast, at a frontal ridge slide just to the northwest (informally called Orca Slide), the glide plane occurs at the same depth as the current BSR. Our new results indicate that the glide plane of the Slipstream slope failure is associated with the contrast between sediments strengthened by gas hydrate and overlying sediments where little or no hydrate is present. In contrast, the glide plane of Orca Slide is between sediment strengthened by hydrate underlain by sediments beneath the gas hydrate stability zone, possibly containing free gas. Additionally, a set of margin perpendicular normal faults are imaged from seafloor down to BSR depth at both frontal ridges. As inferred from the multibeam bathymetry, the estimated volume of the material lost during the slope failure at Slipstream Slide is about 0.33 km3, and ˜0.24 km3 of this volume is present as debris material on the ocean basin floor. The 20 per cent difference is likely due to more widely distributed fine sediments not easily detectable as bathymetric anomalies. These volume estimates on the Cascadia margin are approaching the mass failure volume for other slides that have generated large tsunamis-for example 1-3 km3 for a 1998 Papua New Guinea slide.

Fluorescein Diacetate Microplate Assay in Cell Viability Detection.

PubMed

Chen, Xi; Yang, Xiu-Ying; Fang, Lian-Hua; DU, Guan-Hua

2016-12-20

Objective To investigate the application of the fluorescein diacetate (FDA) microplate assay in cell viability detection. Methods Cells were seeded in a 96-well culture plate until detection. After incubated with FDA,the plate was detected by fluorescence microplate analyzer. The effects of FDA incubation duration,concentration,and other factors on the assay's accuracy and stability were assessed. We also compared the results of FDA with methyl thiazolyl(MTT) in terms of cell numbers and H 2 O 2 injury. Results Within 0-30 minutes,the fluorescence-cell number coefficient of FDA assay increased with duration and reached 0.99 in 27-30 minutes. The optimum concentration of final FDA in this study was 10-30 μg/ml. On cell viability detection,the result of FDA method was equivalent to MTT method. As to H 2 O 2 injury assay,the sensitivity of FDA method was superior to MTT on the higher concentration H 2 O 2 treatment due to a relative shorter duration for detection. Conclusion As a stable and reliable method,FDA is feasible for cell variability detection under varied conditions.

Detecting brain tumor in pathological slides using hyperspectral imaging

PubMed Central

Ortega, Samuel; Fabelo, Himar; Camacho, Rafael; de la Luz Plaza, María; Callicó, Gustavo M.; Sarmiento, Roberto

2018-01-01

Hyperspectral imaging (HSI) is an emerging technology for medical diagnosis. This research work presents a proof-of-concept on the use of HSI data to automatically detect human brain tumor tissue in pathological slides. The samples, consisting of hyperspectral cubes collected from 400 nm to 1000 nm, were acquired from ten different patients diagnosed with high-grade glioma. Based on the diagnosis provided by pathologists, a spectral library of normal and tumor tissues was created and processed using three different supervised classification algorithms. Results prove that HSI is a suitable technique to automatically detect high-grade tumors from pathological slides. PMID:29552415

Detecting brain tumor in pathological slides using hyperspectral imaging.

PubMed

Ortega, Samuel; Fabelo, Himar; Camacho, Rafael; de la Luz Plaza, María; Callicó, Gustavo M; Sarmiento, Roberto

2018-02-01

Hyperspectral imaging (HSI) is an emerging technology for medical diagnosis. This research work presents a proof-of-concept on the use of HSI data to automatically detect human brain tumor tissue in pathological slides. The samples, consisting of hyperspectral cubes collected from 400 nm to 1000 nm, were acquired from ten different patients diagnosed with high-grade glioma. Based on the diagnosis provided by pathologists, a spectral library of normal and tumor tissues was created and processed using three different supervised classification algorithms. Results prove that HSI is a suitable technique to automatically detect high-grade tumors from pathological slides.

Sliding mode control for a two-joint coupling nonlinear system based on extended state observer.

PubMed

Zhao, Ling; Cheng, Haiyan; Wang, Tao

2018-02-01

A two-joint coupling nonlinear system driven by pneumatic artificial muscles is introduced in this paper. A sliding mode controller with extended state observer is proposed to cope with nonlinearities and disturbances for the two-joint coupling nonlinear system. In addition, convergence of the extended state observer is presented and stability analysis of the closed-loop system is also demonstrated with the sliding mode controller. Lastly, some experiments are carried out to show the reality effectiveness of the proposed method. Copyright © 2018 ISA. Published by Elsevier Ltd. All rights reserved.

Cancer Digital Slide Archive: an informatics resource to support integrated in silico analysis of TCGA pathology data

PubMed Central

Gutman, David A; Cobb, Jake; Somanna, Dhananjaya; Park, Yuna; Wang, Fusheng; Kurc, Tahsin; Saltz, Joel H; Brat, Daniel J; Cooper, Lee A D

2013-01-01

Background The integration and visualization of multimodal datasets is a common challenge in biomedical informatics. Several recent studies of The Cancer Genome Atlas (TCGA) data have illustrated important relationships between morphology observed in whole-slide images, outcome, and genetic events. The pairing of genomics and rich clinical descriptions with whole-slide imaging provided by TCGA presents a unique opportunity to perform these correlative studies. However, better tools are needed to integrate the vast and disparate data types. Objective To build an integrated web-based platform supporting whole-slide pathology image visualization and data integration. Materials and methods All images and genomic data were directly obtained from the TCGA and National Cancer Institute (NCI) websites. Results The Cancer Digital Slide Archive (CDSA) produced is accessible to the public (http://cancer.digitalslidearchive.net) and currently hosts more than 20 000 whole-slide images from 22 cancer types. Discussion The capabilities of CDSA are demonstrated using TCGA datasets to integrate pathology imaging with associated clinical, genomic and MRI measurements in glioblastomas and can be extended to other tumor types. CDSA also allows URL-based sharing of whole-slide images, and has preliminary support for directly sharing regions of interest and other annotations. Images can also be selected on the basis of other metadata, such as mutational profile, patient age, and other relevant characteristics. Conclusions With the increasing availability of whole-slide scanners, analysis of digitized pathology images will become increasingly important in linking morphologic observations with genomic and clinical endpoints. PMID:23893318

DeepScope: Nonintrusive Whole Slide Saliency Annotation and Prediction from Pathologists at the Microscope

PubMed Central

Schaumberg, Andrew J.; Sirintrapun, S. Joseph; Al-Ahmadie, Hikmat A.; Schüffler, Peter J.; Fuchs, Thomas J.

2018-01-01

Modern digital pathology departments have grown to produce whole-slide image data at petabyte scale, an unprecedented treasure chest for medical machine learning tasks. Unfortunately, most digital slides are not annotated at the image level, hindering large-scale application of supervised learning. Manual labeling is prohibitive, requiring pathologists with decades of training and outstanding clinical service responsibilities. This problem is further aggravated by the United States Food and Drug Administration’s ruling that primary diagnosis must come from a glass slide rather than a digital image. We present the first end-to-end framework to overcome this problem, gathering annotations in a nonintrusive manner during a pathologist’s routine clinical work: (i) microscope-specific 3D-printed commodity camera mounts are used to video record the glass-slide-based clinical diagnosis process; (ii) after routine scanning of the whole slide, the video frames are registered to the digital slide; (iii) motion and observation time are estimated to generate a spatial and temporal saliency map of the whole slide. Demonstrating the utility of these annotations, we train a convolutional neural network that detects diagnosis-relevant salient regions, then report accuracy of 85.15% in bladder and 91.40% in prostate, with 75.00% accuracy when training on prostate but predicting in bladder, despite different pathologists examining the different tissues. When training on one patient but testing on another, AUROC in bladder is 0.79±0.11 and in prostate is 0.96±0.04. Our tool is available at https://bitbucket.org/aschaumberg/deepscope PMID:29601065

76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-07

...] FDA Transparency Initiative: Improving Transparency to Regulated Industry AGENCY: Food and Drug... the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving Transparency to Regulated Industry.'' The...

77 FR 70955 - FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-28

.... FDA-2012-N-1148] FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products... comments. SUMMARY: The Food and Drug Administration (FDA) is announcing a 1-day public hearing to obtain...

Development of Pain Endpoint Models for Use in Prostate Cancer Clinical Trials and Drug Approval

DTIC Science & Technology

2016-10-01

consensus meeting, with input from investigators in the Prostate Cancer Clinical Trials Consortium, FDA Office of Oncology Drug Products, FDA Study...Cancer Clinical Trials Consortium, FDA Office of Oncology Drug Products, FDA Study Endpoint and Label Development Team, and FDA Division of...Abstract. American Society of Clinical Oncology . Chicago IL, June 1-5, 2013. INVENTIONS, PATENTS AND LICENSES None 11 REPORTABLE OUTCOMES

Affective associative learning modifies the sensory perception of nociceptive stimuli without participant's awareness.

PubMed

Wunsch, Annabel; Philippot, Pierre; Plaghki, Léon

2003-03-01

The present experiment examined the possibility to change the sensory and/or the affective perception of thermal stimuli by an emotional associative learning procedure known to operate without participants' awareness (evaluative conditioning). In a mixed design, an aversive conditioning procedure was compared between subjects to an appetitive conditioning procedure. Both groups were also compared within-subject to a control condition (neutral conditioning). The aversive conditioning was induced by associating non-painful and painful thermal stimuli - delivered on the right forearm - with unpleasant slides. The appetitive conditioning consisted in an association between thermal stimuli - also delivered on the right forearm - and pleasant slides. The control condition consisted in an association between thermal stimuli - delivered for all participants on the left forearm - and neutral slides. The effects of the conditioning procedures on the sensory and affective dimensions were evaluated with visual analogue scale (VAS)-intensity and VAS-unpleasantness. Startle reflex was used as a physiological index of emotional valence disposition. Results confirmed that no participants were aware of the conditioning procedure. After unpleasant slides (aversive conditioning), non-painful and painful thermal stimuli were judged more intense and more unpleasant than when preceded by neutral slides (control condition) or pleasant slides (appetitive conditioning). Despite a strong correlation between the intensity and the unpleasantness scales, effects were weaker for the affective scale and, became statistically non-significant when VAS-intensity was used as covariate. This experiment shows that it is possible to modify the perception of intensity of thermal stimuli by a non-conscious learning procedure based on the transfer of the valence of the unconditioned stimuli (pleasant or unpleasant slides) towards the conditioned stimuli (non-painful and painful thermal stimuli). These results plead for a conception of pain as a conscious output of complex informational processes all of which are not accessible to participants' awareness. Mechanisms by which affective input may influence sensory experience and clinical implications of the present study are discussed.

High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

PubMed

Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

2007-01-01

Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

FDA-approved drugs that are spermatotoxic in animals and the utility of animal testing for human risk prediction.

PubMed

Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo

2018-02-01

This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

NewSpace: The Emerging Commercial Space Industry

NASA Technical Reports Server (NTRS)

Martin, Gary L.

2014-01-01

Presenter will give a lecture on the emerging commercial space industry at International Space University's 2014 Space Studies Program (SSP) at McGill University in Montreal, Canada. The presentation consists of 38 Powerpoint slides and describes the emerging commercial space sector, key players and capabilities. The slides explain which areas that the commercial sector is taking hold, what new markets are attracting start up companies, and which companies are participating. A discussion of how governments can help with the new industry's development is offered.

Ares V: Current Status and Future Capabilities

NASA Technical Reports Server (NTRS)

Sumrall, Phil

2009-01-01

This slide presentation reviews the progress made in the design and development of the Ares V launch vehicle. Included in the presentation are views of the elements of the Ares V, the commonality of the Ares I and V, a chart that shows the progress made in the design of the launcher, description of the current activities around the design and preparation for the Ares V, and a slide describing the prospect of large payload volume and the flexibility that this gives to new space sciences.

Olfactory stimuli as context cues in human memory.

PubMed

Cann, A; Ross, D A

1989-01-01

Olfactory stimuli were used as context cues in a recognition memory paradigm. Male college students were exposed to 50 slides of the faces of college females while in the presence of a pleasant or an unpleasant odor. During the acquisition phase, ratings of physical attractiveness of the slides were collected. After a 48-hr delay, a recognition test was given using the original 50 slides and 50 new slides. The recognition test was conducted with either the original odor or the alternative odor present. A no-odor control group did not receive olfactory cues. The attractiveness ratings indicated that the odor variations had no effect on these social judgments. Analyses of d' scores, hits, and false alarms for the recognition performance indicated support for the predicted interaction in which presence of the same odor at both sessions led to better overall performance.

Performance of Cleared Blood Glucose Monitors.

PubMed

Klonoff, David C; Prahalad, Priya

2015-07-01

Cleared blood glucose monitor (BGM) systems do not always perform as accurately for users as they did to become cleared. We performed a literature review of recent publications between 2010 and 2014 that present data about the frequency of inaccurate performance using ISO 15197 2003 and ISO 15197 2013 as target standards. We performed an additional literature review of publications that present data about the clinical and economic risks of inaccurate BGMs for making treatment decisions or calibrating continuous glucose monitors (CGMs). We found 11 publications describing performance of 98 unique BGM systems. 53 of these 98 (54%) systems met ISO 15197 2003 and 31 of the 98 (32%) tested systems met ISO 15197 2013 analytical accuracy standards in all studies in which they were evaluated. Of the tested systems, 33 were identified by us as FDA-cleared. Among these FDA-cleared BGM systems, 24 out of 32 (75%) met ISO 15197 2003 and 15 out of 31 (48.3%) met ISO 15197 2013 in all studies in which they were evaluated. Among the non-FDA-cleared BGM systems, 29 of 65 (45%) met ISO 15197 2003 and 15 out of 65 (23%) met ISO 15197 2013 in all studies in which they were evaluated. It is more likely that an FDA-cleared BGM system, compared to a non-FDA-cleared BGM system, will perform according to ISO 15197 2003 (χ(2) = 6.2, df = 3, P = 0.04) and ISO 15197 2013 (χ(2) = 11.4, df = 3, P = 0.003). We identified 7 articles about clinical risks and 3 articles about economic risks of inaccurate BGMs. We conclude that a significant proportion of cleared BGMs do not perform at the level for which they were cleared or according to international standards of accuracy. Such poor performance leads to adverse clinical and economic consequences. © 2015 Diabetes Technology Society.

A Comparison of Web Page and Slide/Tape for Instruction in Periapical and Panoramic Radiographic Anatomy.

ERIC Educational Resources Information Center

Ludlow, John B.; Platin, Enrique

2000-01-01

Compared self-guided slide/tape (ST) and Web page (WP) instruction in normal radiographic anatomy of periapical and panoramic images using objective test performance and subjective preferences of 74 freshman dental students. Test performance was not different between image types or presentation technologies, but students preferred WP for…

Even Better Next Time: Making Effective Slide Shows for Rural Social Agencies.

ERIC Educational Resources Information Center

Wallace-Whitaker, Virginia

Practical, detailed steps for producing a slide/tape show are presented in this paper directed to rural social agencies wishing to communicate more effectively with the communities they serve. The paper begins with background information about advertising in relation to the needs and characteristics of rural social agencies and concludes that a…

International Road Signs: Interpretability and Training Techniques.

ERIC Educational Resources Information Center

Griffith, Douglas; Actkinson, Tomme R.

The drivers in a battalion about to be deployed to Germany were taught the meanings of international road signs using one of the following techniques: Sign Only, in which the road signs were presented via a slide projector and the names of the slides provided orally by the instructor; Sign Elaboration, which was identical to the Sign Only…

Sonnets, High Tech, Haiku: Teaching Poetry in the CAI Classroom.

ERIC Educational Resources Information Center

Krebs, Cynthia; Nichols, Chloe

This report emphasizes the techniques required today for effective slide construction and contains suggestions about the nuts and bolts of slide preparation. Two instructors developed a presentation at Utah Valley State College to enhance their teaching of the sonnet and the Japanese haiku. Their premise: since poetry is a highly visual art form,…

Information Comprehension from Longhand Notes and Slides in the Language Classroom

ERIC Educational Resources Information Center

Kiliçkaya, Ferit

2016-01-01

The aim of the study presented in this paper was to compare undergraduate students' information comprehension under conditions where they took notes in longhand during traditional lectures and lectures given through slides. A quasi-experimental approach was adopted to collect the data from 42 participants enrolled in a compulsory course at a state…

Art Tells a Story. Museum by Mail. Classroom Guide.

ERIC Educational Resources Information Center

Faber-Savage, Roxanne

This kit looks at 10 works of art from ancient to modern times and explores their myths, histories, artistic styles, and stories about art and artists. The kit includes goals and background information, 10 slides with slide presentation, art and writing activities, 5 laminated reproductions, and a bibliography. Activities are related to the 10…

Occurrence and methods of control of chemical contaminants in foods.

PubMed

Jelinek, C

1981-06-01

Contamination of food by chemicals can result from their use on agricultural commodities; accidents or misuse during food handling and processing; nucler weapon testing and operation of nuclear power plants; and disposal of industrial chemicals or by-products with subsequent dispersal into the environment. The Food and Drug Administration (FDA), as the Federal agency mainly responsible for evaluating the hazards of chemical contaminants and enforcing any established tolerance levels for them in foods, has been monitoring pesticides, industrial chemicals, metals, and radionuclides in foods in its nationwide programs for many years. In addition, FDA searches for potential contaminants among the approximately 50,000 industrial chemicals manufactured in the United States and coordinates its efforts with those of other Federal and state agencies in these investigations. The overall results of the FDA surveillance and compliance programs for chemical contaminants in foods, as well as specific examples illustrating the wide range of incidents and types of occurrences, are presented.

Food and Drug Administration criteria for the diagnosis of drug-induced valvular heart disease in patients previously exposed to benfluorex: a prospective multicentre study.

PubMed

Maréchaux, Sylvestre; Rusinaru, Dan; Jobic, Yannick; Ederhy, Stéphane; Donal, Erwan; Réant, Patricia; Arnalsteen, Elise; Boulanger, Jacques; Garban, Thierry; Ennezat, Pierre-Vladimir; Jeu, Antoine; Szymanski, Catherine; Tribouilloy, Christophe

2015-02-01

The Food and Drug Administration (FDA) criteria for diagnosis of drug-induced valvular heart disease (DIVHD) are only based on the observation of aortic regurgitation ≥ mild and/or mitral regurgitation ≥ moderate. We sought to evaluate the diagnostic value of FDA criteria in a cohort of control patients and in a cohort of patients exposed to a drug (benfluorex) known to induce VHD. This prospective, multicentre study included 376 diabetic control patients not exposed to valvulopathic drugs and 1000 subjects previously exposed to benfluorex. Diagnosis of mitral or aortic DIVHD was based on a combined functional and morphological echocardiographic analysis of cardiac valves. Patients were classified according to the FDA criteria [mitral or aortic-FDA(+) and mitral or aortic-FDA(-)]. Among the 376 control patients, 2 were wrongly classified as mitral-FDA(+) and 17 as aortic-FDA(+) (0.53 and 4.5% of false positives, respectively). Of those exposed to benfluorex, 48 of 58 with a diagnosis of mitral DIVHD (83%) were classified as mitral-FDA(-), and 901 of the 910 patients (99%) without a diagnosis of the mitral DIVHD group were classified as mitral-FDA(-). All 40 patients with a diagnosis of aortic DIVHD were classified as aortic-FDA(+), and 105 of the 910 patients without a diagnosis of aortic DIVHD (12%) were classified aortic-FDA(+). Older age and lower BMI were independent predictors of disagreement between FDA criteria and the diagnosis of DIVHD in patients exposed to benfluorex (both P ≤ 0.001). FDA criteria solely based on the Doppler detection of cardiac valve regurgitation underestimate for the mitral valve and overestimate for the aortic valve the frequency of DIVHD. Therefore, the diagnosis of DIVHD must be based on a combined echocardiographic and Doppler morphological and functional analysis of cardiac valves. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Seeking approval: Present and future therapies for pemphigus vulgaris

PubMed Central

Mao, Xuming; Payne, Aimee S

2014-01-01

Pemphigus vulgaris is an autoimmune blistering disease of the skin and mucous membranes. Despite the potentially fatal prognosis, there are currently no FDA-approved treatments specifically for pemphigus. In 2006, the FDA designated orphan drug status to mycophenolate mofetil for the treatment of pemphigus vulgaris indicating both federal and commercial interest in developing therapies for this devastating disease. This review focuses on pemphigus therapies that are currently in preclinical or clinical trials, as well as potential novel therapies based on recent advances in the understanding of the pathophysiology of this disease. PMID:18465660

Seeking approval: present and future therapies for pemphigus vulgaris.

PubMed

Mao, Xuming; Payne, Aimee S

2008-05-01

Pemphigus vulgaris is an autoimmune blistering disease of the skin and mucous membranes. Despite the potentially fatal prognosis, there are currently no FDA-approved treatments specifically for pemphigus. In 2006, the FDA designated orphan drug status to mycophenolate mofetil for the treatment of pemphigus vulgaris, indicating both federal and commercial interest in developing therapies for this devastating disease. This review focuses on pemphigus therapies that are currently in preclinical or clinical trials, as well as potential novel therapies based on recent advances in the understanding of the pathophysiology of this disease.

21 CFR 314.103 - Dispute resolution.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.103 Dispute resolution. (a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated...

21 CFR 314.103 - Dispute resolution.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.103 Dispute resolution. (a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated...

21 CFR 314.103 - Dispute resolution.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.103 Dispute resolution. (a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated...

21 CFR 314.103 - Dispute resolution.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.103 Dispute resolution. (a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated...

21 CFR 314.103 - Dispute resolution.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.103 Dispute resolution. (a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated...

Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing.

PubMed

Yim, Seon-Hee; Chung, Yeun-Jun

2014-12-01

In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.

Current FDA directives for promoting public health

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hayes, A.H. Jr.

1982-03-01

The current directions of the FDA are outlined. The underlying philosophy of the FDA under the Reagan Administration is that both the private sector and the government must address the responsibilities to which they are best suited for the health-care system to work more efficiently. To facilitate this, FDA is conducting comprehensive reviews of FDA regulations and the drug-evaluation process. There are many dimensions to promoting public health, and the FDA alone cannot assure an adequate supply of safe and effective drugs. Innovative science and technology are needed to develop new drugs, followed by maximum potentiation (maximum good and leastmore » harm) after FDA approval. Hospital pharmacists have a role in maximizing the potential benefits of drugs through pharmacy and therapeutics committees. The current status of the pilot program for patient package inserts is described. The response at a recent hearing on the program indicates that the responsibility to protect the public health is shared by the government, health professions, industry, and the public. The FDA's campaign on sodium is based on that shared responsibility. By improving communication and building upon their common objections, both pharmacy and the FDA can do their jobs successfully.« less

Extraneous tissue in surgical pathology: a College of American Pathologists Q-Probes study of 275 laboratories.

PubMed

Gephardt, G N; Zarbo, R J

1996-11-01

To develop a multi-institutional reference database of extraneous tissue (contaminants) in surgical pathology. In 1994, participants in the College of American Pathologists Q-Probes quality improvement program performed prospective and retrospective evaluations of extraneous tissue found in surgical pathology microscopic sections for a period of 4 weeks or until 1000 slides were reviewed in each participating laboratory. Two hundred seventy-five surgical pathology laboratories institutions, predominantly from North America. Extraneous tissue contamination rate for slides in prospective and retrospective reviews; staffing and practice procedures; location of extraneous tissue on slides; type of extraneous tissue (normal, abnormal, nonneoplastic, neoplasm, microorganisms, etc); class of extraneous tissue (slide or block contaminants); source of extraneous tissue (different or same case); origin of extraneous tissue (pathology laboratory, physician's office or operating room); and degree of diagnostic difficulty caused by extraneous tissue. Three hundred twenty-one thousand seven hundred fifty-seven slides were reviewed in the prospective study and 57083 slides in the retrospective study. There was an overall extraneous tissue rate of 0.6% of slides (2074/321757) in the prospective study and 2.9% of slides (1653/57083) in the retrospective study. Of those slides with extraneous tissue, the extraneous tissue was located near diagnostic tissue sections in 59.5% of the slides reviewed prospectively and in 25.3% of slides reviewed retrospectively; deeper sections were performed to evaluate extraneous tissue in 12.2% of prospective cases and in 3.1% of retrospective cases. Of the laboratories, 98% had written guidelines for changing solution in tissue processors, and 64.9% had guidelines for maintaining water baths free of extraneous tissue. A total of 98.9% used lens paper, filter bags, or sponges for processing fragmented and small specimens. Written protocols for documentation of extraneous tissue in surgical pathology reports were established in 6.1% of laboratories, for removal of extraneous tissue from blocks in 5.7%, and for removal of extraneous tissue from microscopic slides in 4.7%. In 24% of laboratories no comment or record was kept to document extraneous tissue. Extraneous tissue consisted of neoplasm in 12.7% of the prospectively reviewed slides and in 6.0% of the retrospectively reviewed slides. For the prospective study, 59.4% of extraneous tissue was classified as slide contaminants, and 28.4% was found to be contaminants within the paraffin block; for the retrospective study, 72.9% was classified as slide contaminants and 15.9% as block contaminants. For the prospective study, 63.2% of extraneous tissue was presumed to be from a different case, and in the retrospective study, 48.5% was presumed to be from a different case. Over 90% of extraneous tissue was thought to originate from the pathology laboratory. The degree of diagnostic difficulty caused by extraneous tissue was judged to be severe in 0.4% of slides in the prospective study and 0.1% of slides in the retrospective study. In the prospective study, it could not be determined whether the tissue in the diagnostic sections was extraneous in 0.6% of slides, and in the retrospective study, it could not be determined whether tissue in the diagnostic sections was extraneous in 0.1%. This study has documented the frequency, type, origin, source, and diagnostic difficulty of extraneous tissue and presents benchmarks of extraneous tissue experienced in the general practice of surgical pathology.

76 FR 38184 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0439] Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

Convergence analysis of sliding mode trajectories in multi-objective neural networks learning.

PubMed

Costa, Marcelo Azevedo; Braga, Antonio Padua; de Menezes, Benjamin Rodrigues

2012-09-01

The Pareto-optimality concept is used in this paper in order to represent a constrained set of solutions that are able to trade-off the two main objective functions involved in neural networks supervised learning: data-set error and network complexity. The neural network is described as a dynamic system having error and complexity as its state variables and learning is presented as a process of controlling a learning trajectory in the resulting state space. In order to control the trajectories, sliding mode dynamics is imposed to the network. It is shown that arbitrary learning trajectories can be achieved by maintaining the sliding mode gains within their convergence intervals. Formal proofs of convergence conditions are therefore presented. The concept of trajectory learning presented in this paper goes further beyond the selection of a final state in the Pareto set, since it can be reached through different trajectories and states in the trajectory can be assessed individually against an additional objective function. Copyright © 2012 Elsevier Ltd. All rights reserved.

Clustering methods applied in the detection of Ki67 hot-spots in whole tumor slide images: an efficient way to characterize heterogeneous tissue-based biomarkers.

PubMed

Lopez, Xavier Moles; Debeir, Olivier; Maris, Calliope; Rorive, Sandrine; Roland, Isabelle; Saerens, Marco; Salmon, Isabelle; Decaestecker, Christine

2012-09-01

Whole-slide scanners allow the digitization of an entire histological slide at very high resolution. This new acquisition technique opens a wide range of possibilities for addressing challenging image analysis problems, including the identification of tissue-based biomarkers. In this study, we use whole-slide scanner technology for imaging the proliferating activity patterns in tumor slides based on Ki67 immunohistochemistry. Faced with large images, pathologists require tools that can help them identify tumor regions that exhibit high proliferating activity, called "hot-spots" (HSs). Pathologists need tools that can quantitatively characterize these HS patterns. To respond to this clinical need, the present study investigates various clustering methods with the aim of identifying Ki67 HSs in whole tumor slide images. This task requires a method capable of identifying an unknown number of clusters, which may be highly variable in terms of shape, size, and density. We developed a hybrid clustering method, referred to as Seedlink. Compared to manual HS selections by three pathologists, we show that Seedlink provides an efficient way of detecting Ki67 HSs and improves the agreement among pathologists when identifying HSs. Copyright © 2012 International Society for Advancement of Cytometry.

TU-AB-204-04: Partnerships

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ochs, R.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

Did FDA Decisionmaking Affect Anti-Psychotic Drug Prescribing in Children?: A Time-Trend Analysis.

PubMed

Wang, Bo; Franklin, Jessica M; Eddings, Wesley; Landon, Joan; Kesselheim, Aaron S

2016-01-01

Following Food and Drug Administration (FDA) approval, many drugs are prescribed for non-FDA-approved ("off-label") uses. If substantial evidence supports the efficacy and safety of off-label indications, manufacturers can pursue formal FDA approval through supplemental new drug applications (sNDAs). We evaluated the effect of FDA determinations on pediatric sNDAs for antipsychotic drugs on prescribing of these products in children. Retrospective, segmented time-series analysis using new prescription claims during 2003-2012 for three atypical antipsychotics (olanzapine, quetiapine, ziprasidone). FDA approved the sNDAs for pediatric use of olanzapine and quetiapine in December 2009, but did not approve the sNDA for pediatric use of ziprasidone. During the months before FDA approval of its pediatric sNDA, new prescriptions of olanzapine decreased for both children and adults. After FDA approval, the increase in prescribing trends was similar for both age groups (P = 0.47 for schizophrenia and bipolar disorder; P = 0.37 for other indications). Comparable decreases in use of quetiapine were observed between pediatrics and adults following FDA approval of its pediatric sNDA (P = 0.88; P = 0.63). Prescribing of ziprasidone decreased similarly for pediatric and adult patients after FDA non-approval of its pediatric sNDA (P = 0.61; P = 0.79). The FDA's sNDA determinations relating to use of antipsychotics in children did not result in changes in use that favored the approved sNDAs and disfavored the unapproved sNDA. Improved communication may help translate the agency's expert judgments to clinical practice.

Investigation of Friction and Wear Properties of Electroless Ni-P-Cu Coating Under Dry Condition

NASA Astrophysics Data System (ADS)

Duari, Santanu; Mukhopadhyay, Arkadeb; Barman, Tapan Kr.; Sahoo, Prasanta

This study presents the deposition and tribological characterization of electroless Ni-P-Cu coatings deposited on AISI 1040 steel specimens. After deposition, coatings are heat treated at 500∘C for 1h. Surface morphology study of the coatings reveals its typical cauliflower like appearance. Composition study of the coatings using energy dispersive X-ray analysis indicates that the deposit lies in the high phosphorus range. The coatings undergo crystallization on heat treatment. A significant improvement in microhardness of the coatings is also observed on heat treatment due to the precipitation of hard crystalline phases. The heat-treated coatings are subjected to sliding wear tests on a pin-on-disc type tribo-tester under dry condition by varying the applied normal load, sliding speed and sliding duration. The coefficient of friction (COF) increases with an increase in the applied normal load while it decreases with an increase in the sliding speed. The wear depth on the other hand increases with an increase in applied normal load as well as sliding speed. The worn surface morphology mainly indicates fracture of the nodules.

Wide Field Camera 3 Accommodations for HST Robotics Servicing Mission

NASA Technical Reports Server (NTRS)

Ginyard, Amani

2005-01-01

This slide presentation discusses the objectives of the Hubble Space Telescope (HST) Robotics Servicing and Deorbit Mission (HRSDM), reviews the Wide Field Camera 3 (WFC3), and also reviews the contamination accomodations for the WFC3. The objectives of the HRSDM are (1) to provide a disposal capability at the end of HST's useful life, (2) to upgrade the hardware by installing two new scientific instruments: replace the Corrective Optics Space Telescope Axial Replacement (COSTAR) with the Cosmic Origins Spectrograph (COS), and to replace the Wide Field/Planetary Camera-2 (WFPC2) with Wide Field Camera-3, and (3) Extend the Scientific life of HST for a minimum of 5 years after servicing. Included are slides showing the Hubble Robotic Vehicle (HRV) and slides describing what the HRV contains. There are also slides describing the WFC3. One of the mechanisms of the WFC3 is to serve partially as replacement gyroscopes for HST. There are also slides that discuss the contamination requirements for the Rate Sensor Units (RSUs), that are part of the Rate Gyroscope Assembly on the WFC3.

First-principles comparative study on the interlayer adhesion and shear strength of transition-metal dichalcogenides and graphene

NASA Astrophysics Data System (ADS)

Levita, Giacomo; Molinari, Elisa; Polcar, Tomas; Righi, Maria Clelia

2015-08-01

Due to their layered structure, graphene and transition-metal dichalcogenides (TMDs) are easily sheared along the basal planes. Despite a growing attention towards their use as solid lubricants, so far no head-to-head comparison has been carried out. By means of ab initio modeling of a bilayer sliding motion, we show that graphene is characterized by a shallower potential energy landscape while more similarities are attained when considering the sliding forces; we propose that the calculated interfacial ideal shear strengths afford the most accurate information on the intrinsic sliding capability of layered materials. We also investigate the effect of an applied uniaxial load: in graphene, this introduces a limited increase in the sliding barrier while in TMDs it has a substantially different impact on the possible polytypes. The polytype presenting a parallel orientation of the layers (R 0 ) bears more similarities to graphene while that with antiparallel orientation (R 180 ) shows deep changes in the potential energy landscape and consequently a sharper increase of its sliding barrier.

[Retinal vessels before and after photocoagulation in diabetic retinopathy. Determining the diameter using digitized color fundus slides].

PubMed

Remky, A; Arend, O; Beausencourt, E; Elsner, A E; Bertram, B

1996-01-01

Retinal vessel diameter is an important parameter in blood flow analysis. Despite modern digital image technology, most clinical studies investigate diameters subjectively using projected fundus slides or negatives. In the present study we used a technique to examine vessel diameters by digital image analysis of color fundus slides. We investigated in a retrospective manner diameter changes in twenty diabetic patients before and after panretinal laser coagulation. Color fundus slides were digitized by a new high resolution scanning device. The resulting images consisted in three channels (red, green, blue). Since vessel contrast was the highest in the green channel, we assessed grey value profiles perpendicular to the vessels in the green channel. Diameters were measured at the half-height of the profile. After panretinal laser coagulation, average venous diameter was decreased, whereas arterial diameter remained unchanged. There was no significant relation between the diameter change and the number of laser burns or the presence of neovascularization. Splitting digitized images into color planes enables objective measurements of retinal diameters in conventional color slides.

21 CFR 312.86 - Focused FDA regulatory research.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

21 CFR 312.86 - Focused FDA regulatory research.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

21 CFR 312.86 - Focused FDA regulatory research.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

21 CFR 312.86 - Focused FDA regulatory research.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

76 FR 61709 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0708] Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728, Animal...: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed...

21 CFR 830.120 - Responsibilities of an FDA-accredited issuing agency.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Responsibilities of an FDA-accredited issuing... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA Accreditation of an Issuing Agency § 830.120 Responsibilities of an FDA-accredited issuing agency. To maintain its accreditation, an...

21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

Code of Federal Regulations, 2011 CFR

2011-04-01

... SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications... resubmit to FDA adverse drug experience reports forwarded to the applicant by FDA; however, applicants must submit all followup information on such reports to FDA. Any person subject to the reporting requirements...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

21 CFR 314.108 - New drug product exclusivity.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and... investigation means that before or during the investigation, the applicant was named in Form FDA-1571 filed with FDA as the sponsor of the investigational new drug application under which the investigation was...

77 FR 51949 - Privacy Act, Exempt Record System

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-28

.... FDA-2011-N-0252] Office of the Secretary 45 CFR Part 5b Privacy Act, Exempt Record System AGENCY... Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, ``FDA Records Related to Research Misconduct Proceedings, HHS/FDA...

21 CFR 314.96 - Amendments to an unapproved abbreviated application.

Code of Federal Regulations, 2011 CFR

2011-04-01

... SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Abbreviated... applicant on the same drug product formulation, unless the information has previously been submitted to FDA... and FDA determines that there may be bioequivalence issues or concerns with the product, FDA may...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

Internet Database Review: The FDA BBS.

ERIC Educational Resources Information Center

Tomaiuolo, Nicholas G.

1993-01-01

Describes the electronic bulletin board system (BBS) of the Food and Drug Administration (FDA) that is accessible through the Internet. Highlights include how to gain access; the menu-driven software; other electronic sources of FDA information; and adding value. Examples of the FDA BBS menu and the help screen are included. (LRW)

21 CFR 312.86 - Focused FDA regulatory research.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

10 CFR 35.7 - FDA, other Federal, and State requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false FDA, other Federal, and State requirements. 35.7 Section....7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices. ...

10 CFR 35.7 - FDA, other Federal, and State requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false FDA, other Federal, and State requirements. 35.7 Section....7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices. ...

10 CFR 35.7 - FDA, other Federal, and State requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false FDA, other Federal, and State requirements. 35.7 Section....7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices. ...

77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0339] Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

Code of Federal Regulations, 2013 CFR

2013-04-01

... SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications... resubmit to FDA adverse drug experience reports forwarded to the applicant by FDA; however, applicants must submit all followup information on such reports to FDA. Any person subject to the reporting requirements...

21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

Code of Federal Regulations, 2012 CFR

2012-04-01

... SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications... resubmit to FDA adverse drug experience reports forwarded to the applicant by FDA; however, applicants must submit all followup information on such reports to FDA. Any person subject to the reporting requirements...

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0490] Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

10 CFR 35.7 - FDA, other Federal, and State requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false FDA, other Federal, and State requirements. 35.7 Section....7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices. ...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

10 CFR 35.7 - FDA, other Federal, and State requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false FDA, other Federal, and State requirements. 35.7 Section....7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices. ...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

21 CFR 314.96 - Amendments to an unapproved abbreviated application.

Code of Federal Regulations, 2012 CFR

2012-04-01

... SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Abbreviated... applicant on the same drug product formulation, unless the information has previously been submitted to FDA... and FDA determines that there may be bioequivalence issues or concerns with the product, FDA may...

Registration of organs with sliding interfaces and changing topologies

NASA Astrophysics Data System (ADS)

Berendsen, Floris F.; Kotte, Alexis N. T. J.; Viergever, Max A.; Pluim, Josien P. W.

2014-03-01

Smoothness and continuity assumptions on the deformation field in deformable image registration do not hold for applications where the imaged objects have sliding interfaces. Recent extensions to deformable image registration that accommodate for sliding motion of organs are limited to sliding motion along approximately planar surfaces or cannot model sliding that changes the topological configuration in case of multiple organs. We propose a new extension to free-form image registration that is not limited in this way. Our method uses a transformation model that consists of uniform B-spline transformations for each organ region separately, which is based on segmentation of one image. Since this model can create overlapping regions or gaps between regions, we introduce a penalty term that minimizes this undesired effect. The penalty term acts on the surfaces of the organ regions and is optimized simultaneously with the image similarity. To evaluate our method registrations were performed on publicly available inhale-exhale CT scans for which performances of other methods are known. Target registration errors are computed on dense landmark sets that are available with these datasets. On these data our method outperforms the other methods in terms of target registration error and, where applicable, also in terms of overlap and gap volumes. The approximation of the other methods of sliding motion along planar surfaces is reasonably well suited for the motion present in the lung data. The ability of our method to handle sliding along curved boundaries and for changing region topology configurations was demonstrated on synthetic images.

3D DEM analyses of the 1963 Vajont rock slide

NASA Astrophysics Data System (ADS)

Boon, Chia Weng; Houlsby, Guy; Utili, Stefano

2013-04-01

The 1963 Vajont rock slide has been modelled using the distinct element method (DEM). The open-source DEM code, YADE (Kozicki & Donzé, 2008), was used together with the contact detection algorithm proposed by Boon et al. (2012). The critical sliding friction angle at the slide surface was sought using a strength reduction approach. A shear-softening contact model was used to model the shear resistance of the clayey layer at the slide surface. The results suggest that the critical sliding friction angle can be conservative if stability analyses are calculated based on the peak friction angles. The water table was assumed to be horizontal and the pore pressure at the clay layer was assumed to be hydrostatic. The influence of reservoir filling was marginal, increasing the sliding friction angle by only 1.6˚. The results of the DEM calculations were found to be sensitive to the orientations of the bedding planes and cross-joints. Finally, the failure mechanism was investigated and arching was found to be present at the bend of the chair-shaped slope. References Boon C.W., Houlsby G.T., Utili S. (2012). A new algorithm for contact detection between convex polygonal and polyhedral particles in the discrete element method. Computers and Geotechnics, vol 44, 73-82, doi.org/10.1016/j.compgeo.2012.03.012. Kozicki, J., & Donzé, F. V. (2008). A new open-source software developed for numerical simulations using discrete modeling methods. Computer Methods in Applied Mechanics and Engineering, 197(49-50), 4429-4443.

Wear-caused deflection evolution of a slide rail, considering linear and non-linear wear models

NASA Astrophysics Data System (ADS)

Kim, Dongwook; Quagliato, Luca; Park, Donghwi; Murugesan, Mohanraj; Kim, Naksoo; Hong, Seokmoo

2017-05-01

The research presented in this paper details an experimental-numerical approach for the quantitative correlation between wear and end-point deflection in a slide rail. Focusing the attention on slide rail utilized in white-goods applications, the aim is to evaluate the number of cycles the slide rail can operate, under different load conditions, before it should be replaced due to unacceptable end-point deflection. In this paper, two formulations are utilized to describe the wear: Archard model for the linear wear and Lemaitre damage model for the nonlinear wear. The linear wear gradually reduces the surface of the slide rail whereas the nonlinear one accounts for the surface element deletion (i.e. due to pitting). To determine the constants to use in the wear models, simple tension test and sliding wear test, by utilizing a designed and developed experiment machine, have been carried out. A full slide rail model simulation has been implemented in ABAQUS including both linear and non-linear wear models and the results have been compared with those of the real rails under different load condition, provided by the rail manufacturer. The comparison between numerically estimated and real rail results proved the reliability of the developed numerical model, limiting the error in a ±10% range. The proposed approach allows predicting the displacement vs cycle curves, parametrized for different loads and, based on a chosen failure criterion, to predict the lifetime of the rail.

Slow-slip events on the Whillans Ice Plain, Antarctica, described using rate-and-state friction as an ice stream sliding law

NASA Astrophysics Data System (ADS)

Lipovsky, Bradley Paul; Dunham, Eric M.

2017-04-01

The Whillans Ice Plain (WIP), Antarctica, experiences twice daily tidally modulated stick-slip cycles. Slip events last about 30 min, have sliding velocities as high as ˜0.5 mm/s (15 km/yr), and have total slip ˜0.5 m. Slip events tend to occur during falling ocean tide: just after high tide and just before low tide. To reproduce these characteristics, we use rate-and-state friction, which is commonly used to simulate tectonic faulting, as an ice stream sliding law. This framework describes the evolving strength of the ice-bed interface throughout stick-slip cycles. We present simulations that resolve the cross-stream dimension using a depth-integrated treatment of an elastic ice layer loaded by tides and steady ice inflow. Steady sliding with rate-weakening friction is conditionally stable with steady sliding occurring for sufficiently narrow ice streams relative to a nucleation length. Stick-slip cycles occur when the ice stream is wider than the nucleation length or, equivalently, when effective pressures exceed a critical value. Ice streams barely wider than the nucleation length experience slow-slip events, and our simulations suggest that the WIP is in this slow-slip regime. Slip events on the WIP show a sense of propagation, and we reproduce this behavior by introducing a rate-strengthening region in the center of the otherwise rate-weakening ice stream. If pore pressures are raised above a critical value, our simulations predict that the WIP would exhibit quasi-steady tidally modulated sliding as observed on other ice streams. This study validates rate-and-state friction as a sliding law to describe ice stream sliding styles.

A New Apparatus for Measuring the Temperature at Machine Parts Rotating at High Speeds

NASA Technical Reports Server (NTRS)

Gnam, E.

1945-01-01

After a brief survey of the available methods for measuring the temperatures of machine parts at high speed, in particular turbine blades and rotors, an apparatus is described which is constructed on the principle of induction. Transmission of the measuring current by sliding contacts therefore is avoided. Up-to-date experiments show that it is possible to give the apparatus a high degree of sensitivity and accuracy. In comparison with sliding contact types, the present apparatus shows the important advantage that it operates for any length of time without wear, and that the contact difficulties, particularly occurring at high sliding speeds,are avoided.

Uncertainty Quantification for Robust Control of Wind Turbines using Sliding Mode Observer

NASA Astrophysics Data System (ADS)

Schulte, Horst

2016-09-01

A new quantification method of uncertain models for robust wind turbine control using sliding-mode techniques is presented with the objective to improve active load mitigation. This approach is based on the so-called equivalent output injection signal, which corresponds to the average behavior of the discontinuous switching term, establishing and maintaining a motion on a so-called sliding surface. The injection signal is directly evaluated to obtain estimates of the uncertainty bounds of external disturbances and parameter uncertainties. The applicability of the proposed method is illustrated by the quantification of a four degree-of-freedom model of the NREL 5MW reference turbine containing uncertainties.

Long-term Stability of a Camouflage Retreatment of an Asymmetric Class III/Posterior Open Bite Using Sliding Jigs.

PubMed

Oliveira, Dauro Douglas; de Oliveira, Bruno Franco; Figueiredo, Daniel Santos Fonseca; Antunes, Alberto Nogueira da Gama; Seraidarian, Paulo Isaías

2017-10-01

This article reports the camouflage retreatment of an adult patient presenting an asymmetric Class III malocclusion and posterior open bite. Sliding jigs (SJs) associated with intermaxillary elastics were used. The long-term stability of the excellent results suggests that the use of SJs to correct asymmetric posterior occlusions may be effective.

A morphologic characterisation of the 1963 Vajont Slide, Italy, using long-range terrestrial photogrammetry

NASA Astrophysics Data System (ADS)

Wolter, Andrea; Stead, Doug; Clague, John J.

2014-02-01

The 1963 Vajont Slide in northeast Italy is an important engineering and geological event. Although the landslide has been extensively studied, new insights can be derived by applying modern techniques such as remote sensing and numerical modelling. This paper presents the first digital terrestrial photogrammetric analyses of the failure scar, landslide deposits, and the area surrounding the failure, with a focus on the scar. We processed photogrammetric models to produce discontinuity stereonets, residual maps and profiles, and slope and aspect maps, all of which provide information on the failure scar morphology. Our analyses enabled the creation of a preliminary semi-quantitative morphologic classification of the Vajont failure scar based on the large-scale tectonic folds and step-paths that define it. The analyses and morphologic classification have implications for the kinematics, dynamics, and mechanism of the slide. Metre- and decametre-scale features affected the initiation, direction, and displacement rate of sliding. The most complexly folded and stepped areas occur close to the intersection of orthogonal synclinal features related to the Dinaric and Neoalpine deformation events. Our analyses also highlight, for the first time, the evolution of the Vajont failure scar from 1963 to the present.

Bifurcation of elastic solids with sliding interfaces

NASA Astrophysics Data System (ADS)

Bigoni, D.; Bordignon, N.; Piccolroaz, A.; Stupkiewicz, S.

2018-01-01

Lubricated sliding contact between soft solids is an interesting topic in biomechanics and for the design of small-scale engineering devices. As a model of this mechanical set-up, two elastic nonlinear solids are considered jointed through a frictionless and bilateral surface, so that continuity of the normal component of the Cauchy traction holds across the surface, but the tangential component is null. Moreover, the displacement can develop only in a way that the bodies in contact do neither detach, nor overlap. Surprisingly, this finite strain problem has not been correctly formulated until now, so this formulation is the objective of the present paper. The incremental equations are shown to be non-trivial and different from previously (and erroneously) employed conditions. In particular, an exclusion condition for bifurcation is derived to show that previous formulations based on frictionless contact or `spring-type' interfacial conditions are not able to predict bifurcations in tension, while experiments-one of which, ad hoc designed, is reported-show that these bifurcations are a reality and become possible when the correct sliding interface model is used. The presented results introduce a methodology for the determination of bifurcations and instabilities occurring during lubricated sliding between soft bodies in contact.

Greenland deep boreholes inform on sliding and deformation of the basal ice

NASA Astrophysics Data System (ADS)

Dahl-Jensen, D.

2017-12-01

Repeated measurements of the deformation of the deep boreholes on the Greenland ice sheet informs on the basal sliding, near basal deformation and in general on the horizontal velocity through the ice. Results of the logging of the boreholes at Dye3, GRIP, NGRIP, NEEM and Camp Century through the last 40 years by the Danish Ice and Climate group will be presented and discussed. The results on the flow will be compared with the information on ice properties, impurity load and bedrock entrained material from the deep ice cores and the radio echo sounding images near the drill sites.The results show that the basal movement often happens in an impurity rich zone above the bedrock while pure basal sliding is limited even in the presence of basal water and significant basal melt.Most of the deep ice core sites are located close to ice divides where the surface velocity is limited so significant basal sliding is not expected. Exceptions are the surface velocities at Camp Century and Dye 3, both being 13 m/yr.Finally, the ongoing deep drilling at EGRIP will shortly be presented where we are drilling in the center of the North East Greenland Ice Stream (NEGIS).

Adaptive extended-state observer-based fault tolerant attitude control for spacecraft with reaction wheels

NASA Astrophysics Data System (ADS)

Ran, Dechao; Chen, Xiaoqian; de Ruiter, Anton; Xiao, Bing

2018-04-01

This study presents an adaptive second-order sliding control scheme to solve the attitude fault tolerant control problem of spacecraft subject to system uncertainties, external disturbances and reaction wheel faults. A novel fast terminal sliding mode is preliminarily designed to guarantee that finite-time convergence of the attitude errors can be achieved globally. Based on this novel sliding mode, an adaptive second-order observer is then designed to reconstruct the system uncertainties and the actuator faults. One feature of the proposed observer is that the design of the observer does not necessitate any priori information of the upper bounds of the system uncertainties and the actuator faults. In view of the reconstructed information supplied by the designed observer, a second-order sliding mode controller is developed to accomplish attitude maneuvers with great robustness and precise tracking accuracy. Theoretical stability analysis proves that the designed fault tolerant control scheme can achieve finite-time stability of the closed-loop system, even in the presence of reaction wheel faults and system uncertainties. Numerical simulations are also presented to demonstrate the effectiveness and superiority of the proposed control scheme over existing methodologies.

The debate on FDA reform: a view from the U.S. Senate. Food and Drug Administration.

PubMed

Baker, R

1995-09-01

The recently released concept paper on Food and Drug Administration (FDA) reform from Republican Senator, Nancy Kassebaum, is reviewed. Senator Kassebaum chairs the Senate Committee on Labor and Human Resources that will influence the Senate's action on FDA reform. The paper outlines the Senator's priorities for Congressional legislation on FDA reform in the following areas: the FDA mission and its accountability; creation of a Performance Review Panel and Industry Advisory Council; approval and access of products for seriously ill patients; the FDA's responsibility for good manufacturing practices; establishment of an Ombudsman Office for resolving disputes; dissemination of information on unapproved uses of approved products; and approval standards for new drugs.

Use of data mining at the Food and Drug Administration.

PubMed

Duggirala, Hesha J; Tonning, Joseph M; Smith, Ella; Bright, Roselie A; Baker, John D; Ball, Robert; Bell, Carlos; Bright-Ponte, Susan J; Botsis, Taxiarchis; Bouri, Khaled; Boyer, Marc; Burkhart, Keith; Condrey, G Steven; Chen, James J; Chirtel, Stuart; Filice, Ross W; Francis, Henry; Jiang, Hongying; Levine, Jonathan; Martin, David; Oladipo, Taiye; O'Neill, Rene; Palmer, Lee Anne M; Paredes, Antonio; Rochester, George; Sholtes, Deborah; Szarfman, Ana; Wong, Hui-Lee; Xu, Zhiheng; Kass-Hout, Taha

2016-03-01

This article summarizes past and current data mining activities at the United States Food and Drug Administration (FDA). We address data miners in all sectors, anyone interested in the safety of products regulated by the FDA (predominantly medical products, food, veterinary products and nutrition, and tobacco products), and those interested in FDA activities. Topics include routine and developmental data mining activities, short descriptions of mined FDA data, advantages and challenges of data mining at the FDA, and future directions of data mining at the FDA. Published by Oxford University Press on behalf of the American Medical Informatics Association 2015. This work is written by US Government employees and is in the public domain in the US.

Nonlinear integral sliding mode control design of photovoltaic pumping system: Real time implementation.

PubMed

Chihi, Asma; Ben Azza, Hechmi; Jemli, Mohamed; Sellami, Anis

2017-09-01

The aim of this paper is to provide high performance control of pumping system. The proposed method is designed by an indirect field oriented control based on Sliding Mode (SM) technique. The first contribution of this work is to design modified switching surfaces which presented by adding an integral action to the considered controlled variables. Then, in order to prevent the chattering phenomenon, modified nonlinear component is developed. The SM concept and a Lyapunov function are combined to compute the Sliding Mode Control (SMC) gains. Besides, the motor performance is validated by numeric simulations and real time implementation using a dSpace system with DS1104 controller board. Also, to show the effectiveness of the proposed approach, the obtained results are compared with other techniques such as conventional PI, Proportional Sliding Mode (PSM) and backstepping controls. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

Disturbance observer-based adaptive sliding mode hybrid projective synchronisation of identical fractional-order financial systems

NASA Astrophysics Data System (ADS)

Khan, Ayub; Tyagi, Arti

2018-05-01

In this paper, we have studied the hybrid projective synchronisation for incommensurate, integer and commensurate fractional-order financial systems with unknown disturbance. To tackle the problem of unknown bounded disturbance, fractional-order disturbance observer is designed to approximate the unknown disturbance. Further, we have introduced simple sliding mode surface and designed adaptive sliding mode controllers incorporating with the designed fractional-order disturbance observer to achieve a bounded hybrid projective synchronisation between two identical fractional-order financial model with different initial conditions. It is shown that the slave system with disturbance can be synchronised with the projection of the master system generated through state transformation. Simulation results are presented to ensure the validity and effectiveness of the proposed sliding mode control scheme in the presence of external bounded unknown disturbance. Also, synchronisation error for commensurate, integer and incommensurate fractional-order financial systems is studied in numerical simulation.

The Drug Facts Box: Improving the communication of prescription drug information.

PubMed

Schwartz, Lisa M; Woloshin, Steven

2013-08-20

Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label--the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing--may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and "spinning" unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies--including national randomized trials--demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3-5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information.

The Drug Facts Box: Improving the communication of prescription drug information

PubMed Central

Schwartz, Lisa M.; Woloshin, Steven

2013-01-01

Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label—the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing—may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and “spinning” unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies—including national randomized trials—demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3–5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information. PMID:23942130

Foreword: Follow-on Biologics: Implementation Challenges and Opportunities.

PubMed

Paradise, Jordan

2011-01-01

This Book of the Seton Hall Law Review presents the contributions to Follow-On Biologics: Implementation Challenges and Opportunities, a one-day roundtable event hosted by Seton Hall University School of Law in the fall of 2010. The roundtable fostered an international dialogue regarding the future of follow-on biologics in the United States resulting from the Patient Protection and Affordable Care Act of March 2010. THE BIOLOGIC PRICE COMPETITION AND INNOVATION ACT OF 2010. The March 23, 2010, enactment of the Patient Protection and Affordable Care Act (PPACA) and the companion Health Care and Education Affordability Reconciliation Act of 2010 ushered in landmark reform of the American health care system. Along with sweeping overhauls of the health care system generally, PPACA also provides a new regulatory challenge for the Food and Drug Administration (FDA). A subtitle within PPACA, the Biologics Price Competition and Innovation Act (BPCIA), bestows upon FDA broad authority to implement an abbreviated approval route to market for biological products (also known as biologics) that are "biosimilar" to an existing marketed product. The brief introduction will provide a basic comparison of biologics and conventional pharmaceutical drugs that will prove central to the FDA's development of this follow-on biologic pathway as well as specifically examine the content and scope of the BPCIA provisions and identify future challenges for the FDA. It will conclude by highlighting details of presentations during the roundtable held at the Seton Hall University School of Law and introduce the two resulting articles contained with this Book of the Seton Hall Law Review.

Evaluation of Radiation Doses Due to Consumption of Contaminated Food Items and Calculation of Food Class-Specific Derived Intervention Levels

DOE Office of Scientific and Technical Information (OSTI.GOV)

Heinzelman, K M; Mansfield, W G

This document evaluates the expected radiation dose due to the consumption of several specific food classes (dairy, meat, produce, etc.) contaminated with specific radionuclides, and relates concentration levels in food to the detection abilities of typical aboratory analysis/measurement methods. The attached charts present the limiting organ dose as a function of the radionuclide concentration in a particular food class, and allow the user to compare these concentrations and doses to typical analytical detection apabilities. The expected radiation dose depends on several factors: the age of the individual; the radionuclide present in the food; the concentration of the radionuclide in themore » food; and the amount of food consumed. Food consumption rates for individuals of various ges were taken from the 1998 United States Food and Drug Administration (FDA) document, Accidental Radioactive Contamination of HUman Food and Animal Feeds: Recommendations for State and Local Agencies. In that document, the FDA defines the erived Intervention Level (DIL), which is the concentration of a particular radionuclide in food that if consumed could result in an individual receiving a radiation dose exceeding the Protection Action Guide (PAG) thresholds for intervention. This document also resents odified, food class specific DIL, which is calculated using a somewhat modified version of the FDA's procedure. This document begins with an overview of the FDA's DIL calculation, followed by a description of the food class specific DIL calculations, and finally charts of the radiation dose per radioactivity concentration for several food class/radionuclide combinations.« less

21 CFR 316.34 - FDA recognition of exclusive approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false FDA recognition of exclusive approval. 316.34... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable) timely...

21 CFR 807.100 - FDA action on a premarket notification.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to be...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

21 CFR 316.34 - FDA recognition of exclusive approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false FDA recognition of exclusive approval. 316.34... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable) timely...

21 CFR 60.20 - FDA action on regulatory review period determinations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period determinations. (a) FDA will consult its records and experts to verify the dates...

21 CFR 316.34 - FDA recognition of exclusive approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false FDA recognition of exclusive approval. 316.34... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable) timely...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

21 CFR 314.125 - Refusal to approve an application.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...

21 CFR 60.20 - FDA action on regulatory review period determinations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period determinations. (a) FDA will consult its records and experts to verify the dates...

76 FR 31615 - Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0305] Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

21 CFR 60.10 - FDA assistance on eligibility.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA assistance on eligibility. 60.10 Section 60.10... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in...

21 CFR 60.10 - FDA assistance on eligibility.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA assistance on eligibility. 60.10 Section 60.10... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in...

21 CFR 314.110 - Complete response letter to the applicant.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... response letter. FDA will send the applicant a complete response letter if the agency determines that we...) Complete review of data. A complete response letter reflects FDA's complete review of the data submitted in...

21 CFR 314.110 - Complete response letter to the applicant.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... response letter. FDA will send the applicant a complete response letter if the agency determines that we...) Complete review of data. A complete response letter reflects FDA's complete review of the data submitted in...

77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0080... Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``FDA... that address nearly all aspects of the FDA approval and surveillance processes, including application...

21 CFR 60.20 - FDA action on regulatory review period determinations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period determinations. (a) FDA will consult its records and experts to verify the dates...

21 CFR 807.100 - FDA action on a premarket notification.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to be...

21 CFR 807.100 - FDA action on a premarket notification.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to be...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

21 CFR 314.125 - Refusal to approve an application.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...

21 CFR 830.110 - Application for accreditation as an issuing agency.

Code of Federal Regulations, 2014 CFR

2014-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA Accreditation of an Issuing Agency.... (1) An applicant seeking initial FDA accreditation as an issuing agency shall notify FDA of its desire to be accredited by sending a notification by email to [email protected]fda.hhs.gov, or by correspondence to...

21 CFR 60.20 - FDA action on regulatory review period determinations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period determinations. (a) FDA will consult its records and experts to verify the dates...

21 CFR 314.110 - Complete response letter to the applicant.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... response letter. FDA will send the applicant a complete response letter if the agency determines that we...) Complete review of data. A complete response letter reflects FDA's complete review of the data submitted in...

29 CFR 1987.108 - Role of Federal agencies.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) PROCEDURES FOR HANDLING RETALIATION COMPLAINTS UNDER SECTION 402 OF THE FDA FOOD SAFETY...) The FDA, if interested in a proceeding, may participate as amicus curiae at any time in the proceeding, at the FDA's discretion. At the request of the FDA, copies of all documents in a case must be sent to...

21 CFR 314.125 - Refusal to approve an application.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...

21 CFR 807.100 - FDA action on a premarket notification.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to be...

21 CFR 314.110 - Complete response letter to the applicant.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... response letter. FDA will send the applicant a complete response letter if the agency determines that we...) Complete review of data. A complete response letter reflects FDA's complete review of the data submitted in...

76 FR 32367 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0742 (formerly Docket No. 1999D-4396)] Draft Guidance for Clinical Investigators, Industry, and FDA Staff...: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared...

78 FR 29141 - Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff... Administration (FDA) is announcing the availability of the guidance entitled ``Center for Devices and...

21 CFR 60.20 - FDA action on regulatory review period determinations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period determinations. (a) FDA will consult its records and experts to verify the dates...

21 CFR 801.57 - Discontinuation of legacy FDA identification numbers assigned to devices.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Discontinuation of legacy FDA identification... Device Identification § 801.57 Discontinuation of legacy FDA identification numbers assigned to devices... been assigned an FDA labeler code to facilitate use of NHRIC or NDC numbers may continue to use that...

78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0286] Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or... Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled...

21 CFR 60.10 - FDA assistance on eligibility.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA assistance on eligibility. 60.10 Section 60.10... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in...

21 CFR 316.34 - FDA recognition of exclusive approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false FDA recognition of exclusive approval. 316.34... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable) timely...

21 CFR 314.125 - Refusal to approve an application.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...

21 CFR 316.34 - FDA recognition of exclusive approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false FDA recognition of exclusive approval. 316.34... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable) timely...

75 FR 11893 - Food and Drug Administration Transparency Task Force; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-12

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247... Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration (FDA) is soliciting comments from interested persons on ways in which FDA can increase transparency between FDA and...

77 FR 71803 - Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0080... and Drug Administration (FDA) is announcing the availability of a guidance entitled ``FDA Oversight of... nearly all aspects of the FDA approval and surveillance processes, including application submission...

21 CFR 314.110 - Complete response letter to the applicant.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... response letter. FDA will send the applicant a complete response letter if the agency determines that we...) Complete review of data. A complete response letter reflects FDA's complete review of the data submitted in...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

21 CFR 314.125 - Refusal to approve an application.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...

21 CFR 807.100 - FDA action on a premarket notification.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to be...

21 CFR 60.10 - FDA assistance on eligibility.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA assistance on eligibility. 60.10 Section 60.10... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in...

76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

76 FR 56205 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-12

... Products Scientific Advisory Committee, notify FDA in writing. FDA is also requesting nominations for... letters stating interest in participating in the selection process to FDA by October 12, 2011 (see... candidates should be sent to FDA by October 12, 2011. ADDRESSES: All letters of interest and nominations...

Regulating (for the benefit of) future persons: a different perspective on the FDA's jurisdiction to regulate human reproductive cloning.

PubMed

Javitt, Gail H; Hudson, Kathy

2003-01-01

The Food and Drug Administration (FDA) has taken the position that human reproductive cloning falls within its regulatory jurisdiction. This position has been subject to criticism on both procedural and substantive grounds. Some have contended that the FDA has failed to follow administrative law principles in asserting its jurisdiction, while others claim the FDA is ill suited to the task of addressing the ethical and social implications of human cloning. This Article argues, that, notwithstanding these criticisms, the FDA could plausibly assert jurisdiction over human cloning as a form of human gene therapy, an area in which the FDA is already regarded as having primary regulatory authority. Such an assertion would require that the FDA's jurisdiction extend to products affecting future persons, i.e., those not yet born. This Article demonstrates, for the first time, that such jurisdiction was implicit in the enactment of the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act and that the FDA has historically relied on such authority in promulgating regulations for drugs and devices.

Landslides in the New Madrid seismic zone

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jibson, R.W.; Keefer, D.K.

1985-01-01

During the New Madrid earthquakes of 1811-12, bluffs bordering the Mississippi alluvial plain in the epicentral region underwent large-scale landsliding. Between Cairo, Illinois and Memphis, Tennessee, the authors mapped 221 large landslides of three types: (1) old, eroded, coherent block slides and slumps; (2) old earth flows; and (3) young, fresh slumps that occur only along near-river bluffs and are the only landslides present along such bluffs. Historical accounts and field evidence indicate that most or all old coherent slides and earth flows date to the 1811-12 earthquakes and that the only currently active, large-scale landsliding in the area occursmore » along bluffs bordering the river. Analysis of old coherent slides and earth flows indicates that landslide distribution is most strongly affected by slope height, but that proximity to the hypocenters of the 1811-12 earthquakes also has a significant effect. Slope-stability analyses of an old coherent slide and an earth flow selected as representative of the principal kinds of landslides present indicate that both were stable in aseismic conditions even when water tables were at highest possible levels. However, a dynamic Newmark displacement analysis shows that ground shaking such as that in 1811-12 would cause large displacements leading to catastrophic failure in both slides. These results indicate that in large earthquakes landsliding in much of the study are is likely. Moderate earthquakes may also trigger landslides at some locations.« less

EBOLA and FDA: reviewing the response to the 2014 outbreak, to find lessons for the future

PubMed Central

Largent, Emily A.

2016-01-01

Abstract In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in history. At the onset of the outbreak—as now—there were no therapies approved by the U.S. Food and Drug Administration (FDA) for prevention of, post-exposure prophylaxis against, or treatment of EVD. As a result, the outbreak spurred interest in developing novel treatments, sparked calls to use experimental interventions in the field, and highlighted challenges to the standard approach to FDA approval of new drugs. Although the outbreak was geographically centered in West Africa, it showcased FDA's global role in drug development, approval, and access. FDA's response to EVD highlights the panoply of agency powers and demonstrates the flexibility of FDA's regulatory framework. This paper evaluates the strengths and weaknesses of FDA's response and makes policy recommendations regarding how FDA should respond to new and re-emerging public health threats. In particular, it argues that greater emphasis should be placed on drug development in interoutbreak periods and on assuring access to approved products. The current pandemic of Zika virus infection is but one example of an emerging health threat that will require FDA involvement in order to achieve a successful response. PMID:28852537

A Critical Review of Methods to Evaluate the Impact of FDA Regulatory Actions

PubMed Central

Briesacher, Becky A.; Soumerai, Stephen B.; Zhang, Fang; Toh, Sengwee; Andrade, Susan E.; Wagner, Joann L.; Shoaibi, Azadeh; Gurwitz, Jerry H.

2013-01-01

Purpose To conduct a synthesis of the literature on methods to evaluate the impacts of FDA regulatory actions, and identify best practices for future evaluations. Methods We searched MEDLINE for manuscripts published between January 1948 and August 2011 that included terms related to FDA, regulatory actions, and empirical evaluation; the review additionally included FDA-identified literature. We used a modified Delphi method to identify preferred methodologies. We included studies with explicit methods to address threats to validity, and identified designs and analytic methods with strong internal validity that have been applied to other policy evaluations. Results We included 18 studies out of 243 abstracts and papers screened. Overall, analytic rigor in prior evaluations of FDA regulatory actions varied considerably; less than a quarter of studies (22%) included control groups. Only 56% assessed changes in the use of substitute products/services, and 11% examined patient health outcomes. Among studies meeting minimal criteria of rigor, 50% found no impact or weak/modest impacts of FDA actions and 33% detected unintended consequences. Among those studies finding significant intended effects of FDA actions, all cited the importance of intensive communication efforts. There are preferred methods with strong internal validity that have yet to be applied to evaluations of FDA regulatory actions. Conclusions Rigorous evaluations of the impact of FDA regulatory actions have been limited and infrequent. Several methods with strong internal validity are available to improve trustworthiness of future evaluations of FDA policies. PMID:23847020

A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.

PubMed

Zeukeng, Minette-Joëlle; Seoane-Vazquez, Enrique; Bonnabry, Pascal

2018-06-01

This study compared the characteristics of new human drugs approved by the Food and Drug Administration (FDA), the European Medicine Agency (EMA), and Swissmedic (SMC) in the period 2007 to 2016. The list of new drugs and therapeutic biologics approved by the FDA, the EMA, and SMC in the period 2007 to 2016 was collected from websites of those agencies. The study included regulatory information, approval date, and indication for each drug. Descriptive statistical t tests and x 2 -tests were performed for the analysis. From 2007 to 2016, 134 new drugs were approved by all three regulatory agencies. Overall, 66.4% of the drugs were first approved by the FDA, 30.6% by the EMA, and 3.0% by SMC. The difference in approval dates between SMC and the EMA, SMC and the FDA, and the FDA and the EMA were statistically significant. The indications approved by the FDA, the EMA, and SMC for the same drugs were similar in content for 23.1% drugs and different in 76.9% of the drugs. Significant differences in indications existed between the FDA and SMC and the FDA and the EMA, but not between the EMA and SMC. There were differences in the characteristics of new drugs approved by the EMA, the FDA, and SMC in the period 2007-2016. Overall, two thirds of the new drugs were first approved by the FDA. Differences in indications were found in three out of four new drugs approved by the three regulatory agencies. Despite international drug regulation harmonization efforts, significant differences in the characteristics of new drugs approved by different agencies persist.

Was Project Management Life Really Better in Apollo?

NASA Technical Reports Server (NTRS)

2010-01-01

This slide presentation discusses the question of "Was Project Management Life Really Better in Apollo?" Was money really flowing freely all through Apollo? Are we wallowing in nostalgia and comparing current circumstances to a managerial time which did not exist? This talk discusses these and other questions as background for you as today s project managers. There are slides showing the timelines from before the speech that Kennedy gave promising to land a man on the moon, to the early 60's, when the manned space center prepared the preliminary lunar landing mission design, an NASA organization chart from 1970, various photos of the rockets, and the astronauts are presented. The next slides discuss the budgets from the 1960's to the early 1970's. Also the results of a survey of 62 managers, who were asked "What problems pose the greatest obstacles to successful project performance?"

Slide Conveying of Granular Materials-Thinking Out of the Glovebox

NASA Technical Reports Server (NTRS)

Goddard, J. D.; Didwania, A. K.; Nott, P. R.

2000-01-01

The vibratory conveyor, routinely employed for normal-gravity transport of granular materials, usually consists of a continuous open trough vibrated sinusoidally to induce axial movement of a granular material. Motivated in part by a hypothetical application in zero gravity, we propose a novel modification of the vibratory conveyor based on a closed 2d trough operating in a "slide-conveying" mode, with the granular mass remaining permanently in contact with the trough walls. We present a detailed analysis of the mechanics of transport, based on a rigid-slab model for the granular mass with frictional (Coulomb) slip at the upper and lower walls. The form of the vibration cycle plays a crucial role, and the optimal conveying cycle is not the commonly assumed rectilinear sinusoidal motion. The conveying efficiency for the novel slide conveyor will be presented for several simple vibration cycles, including one believed to represent the theoretical optimum.

Computer-assisted image processing to detect spores from the fungus Pandora neoaphidis.

PubMed

Korsnes, Reinert; Westrum, Karin; Fløistad, Erling; Klingen, Ingeborg

2016-01-01

This contribution demonstrates an example of experimental automatic image analysis to detect spores prepared on microscope slides derived from trapping. The application is to monitor aerial spore counts of the entomopathogenic fungus Pandora neoaphidis which may serve as a biological control agent for aphids. Automatic detection of such spores can therefore play a role in plant protection. The present approach for such detection is a modification of traditional manual microscopy of prepared slides, where autonomous image recording precedes computerised image analysis. The purpose of the present image analysis is to support human visual inspection of imagery data - not to replace it. The workflow has three components:•Preparation of slides for microscopy.•Image recording.•Computerised image processing where the initial part is, as usual, segmentation depending on the actual data product. Then comes identification of blobs, calculation of principal axes of blobs, symmetry operations and projection on a three parameter egg shape space.

A case of adenocarcinoma of the rete testis accompanied by focal adenomatous hyperplasia

PubMed Central

2013-01-01

Abstract Adenocarcinoma of the rete testis is very rare. There is still little knowledge about its etiology and pathogenesis. Herein, we present a case of rete testis adenocarcinoma in a 36-year-old Chinese male. The tumor was predominantly composed of irregular small tubules and papillary structures with cuboidal or polygonal cells. In peripheral area of the tumor, the remaining normal rete testis and adenomatous hyperplasia of the rete testis could also be seen, indicating the possible relationship between adenomatous hyperplasia and adenocarcinoma. In addition, the patient underwent a left hydrocelectomy because of the existence of hydrocele 3 years ago. But, it is unclear whether hydrocele and hydrocelectomy is its cause or just the early clinical presentation of the adenocarcinoma. Virtual slides The virtual slide(s) for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/6757609119625499 PMID:23800084

Spin in RCTs of anxiety medication with a positive primary outcome: a comparison of concerns expressed by the US FDA and in the published literature.

PubMed

Beijers, Lian; Jeronimus, Bertus F; Turner, Erick H; de Jonge, Peter; Roest, Annelieke M

2017-03-29

This study aimed to determine the presence of spin in papers on positive randomised clinical trials (RCTs) of antidepressant medication for anxiety disorders by comparing concerns expressed in the Food and Drug Administration (FDA) reviews with those expressed in the published paper. For every positive anxiety medication trial with a matching publication (n=41), two independent reviewers identified the concerns raised in the US FDA reviews and those in the published literature. Spin was identified when concerns or limitations were expressed by the FDA (about the efficacy of the study drug) but not in the corresponding published paper. Concerns mentioned in the papers but not by the FDA were scored as 'non-FDA' concerns. Only six out of 35 (17%) of the FDA concerns pertaining to drug efficacy were reported in the papers. Two papers mentioned a concern that fit the FDA categories, but was not mentioned in the corresponding FDA review. Eighty-seven non-FDA concerns were counted, which often reflected general concerns or concerns related to the study design. Results indicate the presence of substantial spin in the clinical trial literature on drugs for anxiety disorders. In papers describing RCTs on anxiety medication, the concerns raised by the authors differed from those raised by the FDA. Published papers mentioned a large number of generic concerns about RCTs, such as a lack of long-term research and limited generalisability, while they mentioned few concerns about drug efficacy. These results warrant the promotion of independent statistical review, reporting of patient-level data, more study of spin, and an increased expectation that authors report FDA concerns. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Enhancing the incorporation of the patient's voice in drug development and evaluation.

PubMed

Chalasani, Meghana; Vaidya, Pujita; Mullin, Theresa

2018-01-01

People living with a condition are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. In 2012, the U.S. Food and Drug Administration (FDA) established the Patient-Focused Drug Development (PFDD) initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. PFDD meetings are unique among FDA public meetings, with a format designed to engage patients and elicit their perspectives on two topic areas: (1) the most significant symptoms of their condition and the impact of the condition on daily life; and, (2) their current approaches to treatment. FDA has conducted 24 disease-specific PFDD meetings to date. The lessons learned from PFDD meetings range from experiences common across rare diseases to more disease specific experiences that matter most to patients. FDA recognizes that FDA-led PFDD meetings alone cannot address the gaps in information on the patient perspective. Patient-focused drug development is an ongoing effort and FDA looks forward to the next steps in advancing the science and the utilization of patient input throughout drug development and evaluation. The U.S. Food and Drug Administration (FDA) has multiple mechanisms for its regulators and staff to interact with patients -- but none quite like its novel Patient-Focused Drug Development (PFDD) initiative. FDA established the PFDD initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. Since the initiative's inception in 2012, FDA has held 24 PFDD meetings, covering a range of disease areas and hearing directly from thousands of patients and caregivers. FDA's PFDD meetings have also provided key stakeholders, including patient advocates, researchers, drug developers, healthcare providers, and other government officials, an opportunity to hear the patient's voice. The lessons learned include but are not limited to specific experiences that matter most to patients, patient perspectives on meaningful treatment benefits and how patients want to be engaged in the drug development process. FDA recognizes that FDA-led PFDD meetings alone cannot address the gaps in information on the patient perspective. Further enhancing the incorporation of the patient's voice in drug development and evaluation continues to be a priority for FDA.

Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.

PubMed

Rathi, Vinay K; Krumholz, Harlan M; Masoudi, Frederick A; Ross, Joseph S

2015-08-11

The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle. To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. All clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. Studies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. In 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer/investigator-initiated postmarket studies, respectively. Approximately half of all studies used no comparator (pivotal: 13/30 [43.3%]; completed postmarket: 16/26 [61.5%]; ongoing postmarket: 70/153 [45.8%]). Median duration of primary effectiveness end point follow-up was 3.0 months (IQR, 3.0-12.0), 9.0 months (IQR, 0.3-12.0), and 12.0 months (IQR, 7.0-24.0) for pivotal, completed postmarket, and ongoing postmarket studies, respectively. Among high-risk therapeutic devices approved via the FDA PMA pathway, total product life cycle evidence generation varied in both the number and quality of premarket and postmarket studies, with approximately 13% of initiated postmarket studies completed between 3 and 5 years after FDA approval.

The FDA's Experience with Emerging Genomics Technologies-Past, Present, and Future.

PubMed

Xu, Joshua; Thakkar, Shraddha; Gong, Binsheng; Tong, Weida

2016-07-01

The rapid advancement of emerging genomics technologies and their application for assessing safety and efficacy of FDA-regulated products require a high standard of reliability and robustness supporting regulatory decision-making in the FDA. To facilitate the regulatory application, the FDA implemented a novel data submission program, Voluntary Genomics Data Submission (VGDS), and also to engage the stakeholders. As part of the endeavor, for the past 10 years, the FDA has led an international consortium of regulatory agencies, academia, pharmaceutical companies, and genomics platform providers, which was named MicroArray Quality Control Consortium (MAQC), to address issues such as reproducibility, precision, specificity/sensitivity, and data interpretation. Three projects have been completed so far assessing these genomics technologies: gene expression microarrays, whole genome genotyping arrays, and whole transcriptome sequencing (i.e., RNA-seq). The resultant studies provide the basic parameters for fit-for-purpose application of these new data streams in regulatory environments, and the solutions have been made available to the public through peer-reviewed publications. The latest MAQC project is also called the SEquencing Quality Control (SEQC) project focused on next-generation sequencing. Using reference samples with built-in controls, SEQC studies have demonstrated that relative gene expression can be measured accurately and reliably across laboratories and RNA-seq platforms. Besides prediction performance comparable to microarrays in clinical settings and safety assessments, RNA-seq is shown to have better sensitivity for low expression and reveal novel transcriptomic features. Future effort of MAQC will be focused on quality control of whole genome sequencing and targeted sequencing.

Compounding pharmacy conundrum: "we cannot live without them but we cannot live with them" according to the present paradigm.

PubMed

Guharoy, Roy; Noviasky, John; Haydar, Ziad; Fakih, Mohamad G; Hartman, Christian

2013-04-01

Compounding pharmacies serve a critical role in modern health care to meet special patient care needs. Although the US Food and Drug Administration (FDA) has clearly delineated jurisdiction over drug companies and products manufactured under Good Manufacturing Practice (GMP) regulations to ensure quality, potency, and purity, compounding pharmacies are regulated by the State Boards and are not registered by the FDA. In recent years, some compounding pharmacies acted like a manufacturer, preparing large amounts of injectable drugs with interstate activities. Multiple outbreaks have been linked to compounding pharmacies, including a recent outbreak of fungal meningitis related to contaminated methylprednisolone, exposing > 14,000 patients in multiple states. This tragedy underscores the urgency of addressing safety related to compounding pharmacies. There is a call for action at the federal and state levels to set minimum production standards, impose new labeling conditions on compounded drugs, and require large-scale compounders be regulated by the FDA. "Industrial" compounding must come under FDA oversight, require those pharmacies to meet GMP standards, and ensure quality and safe products for patient use. Moreover, compliance with the Institute for Safe Medication Practices 2011 recommendations that any type of sterile compounding must be in compliance with the United States Pharmacopoeia chapter 797 guidelines will reduce the risk of patient harm from microbial contamination. Finally, other critical factors that require close attention include addressing injectable products compounded in hospitals and other outpatient health-care centers. The FDA and State Boards of Pharmacy must be adequately funded to exercise the oversight effectively.

75 FR 29561 - Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004] [FDA 225-09-0012] Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com... Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Drugs.Com. The...

21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... application. (a) FDA will refuse to approve an abbreviated application for a new drug under section 505(j) of... FDA with respect to the active ingredient, route of administration, dosage form, or strength that is...

21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 3 2011-04-01 2011-04-01 false The Food and Drug Administration's (FDA's... and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. (a) If data or other information available to FDA, including data...

21 CFR 314.105 - Approval of an application and an abbreviated application.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...

21 CFR 314.105 - Approval of an application and an abbreviated application.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...

21 CFR 806.30 - FDA access to records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA access to records. 806.30 Section 806.30 Food... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all reasonable...

21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 3 2014-04-01 2014-04-01 false The Food and Drug Administration's (FDA's... (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's... data or other information available to FDA, including data not submitted by the manufacturer or...

21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... application. (a) FDA will refuse to approve an abbreviated application for a new drug under section 505(j) of... FDA with respect to the active ingredient, route of administration, dosage form, or strength that is...

21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 3 2010-04-01 2009-04-01 true The Food and Drug Administration's (FDA's... and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. (a) If data or other information available to FDA, including data...

21 CFR 516.34 - FDA recognition of exclusive marketing rights.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false FDA recognition of exclusive marketing rights. 516... SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive marketing rights. (a) FDA will send the sponsor (or the permanent-resident U.S. agent, if applicable) timely...

21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...