A randomized trial on effectiveness of artemether-lumefantrine versus artesunate plus amodiaquine for unsupervised treatment of uncomplicated Plasmodium falciparum malaria in Ghanaian children

PubMed Central

Kobbe, Robin; Klein, Philipp; Adjei, Samuel; Amemasor, Solomon; Thompson, William Nana; Heidemann, Hanna; Nielsen, Maja V; Vohwinkel, Julia; Hogan, Benedikt; Kreuels, Benno; Bührlen, Martina; Loag, Wibke; Ansong, Daniel; May, Jürgen

2008-01-01

Background Numerous trials have demonstrated high efficacy and safety of artemisinin-based combination therapy (ACT) under supervised treatment. In contrast, effectiveness studies comparing different types of ACT applied unsupervised are scarce. The aim of this study was to compare effectiveness, tolerability and acceptance of artesunate plus amodiaquine (ASAQ) against that of artemether-lumefantrine (AL) in Ghanaian children with uncomplicated Plasmodium falciparum malaria. Methods A randomized open-label trial was conducted at two district hospitals in the Ashanti region, Ghana, an area of intense malaria transmission. A total of 246 children under five years of age were randomly assigned to either ASAQ (Arsucam®) or AL (Coartem®). Study participants received their first weight-adjusted dose under supervision. After the parent/guardian was advised of times and mode of administration the respective three-day treatment course was completed unobserved at home. Follow-up visits were performed on days 3, 7, 14 and 28 to evaluate clinical and parasitological outcomes, adverse events, and haematological recovery. Length polymorphisms of variable regions of msp1 and msp2 were determined to differentiate recrudescences from reinfections. Acceptance levels of both treatment regimens were assessed by means of standardized interviews. Results Adequate clinical and parasitological responses after AL and ASAQ treatment were similar (88.3% and 91.7%, respectively). Interestingly, more late clinical failures until day 28 occurred in AL-treated children than in those who received ASAQ (17.5% and 7.3%, respectively; Hazard Ratio 2.41, 95% CI 1.00–5.79, p < 0.05). Haematological recovery and drug tolerability were not found to be significantly different in both study arms. The acceptance of treatment with ASAQ was higher than that with AL (rank-scores 10.6 and 10.3, respectively; p < 0.05). Conclusion Unobserved AL and ASAQ treatment showed high adequate clinical and parasitological responses, though AL was inferior in preventing late clinical failures. PMID:19099594

Machine-Learned Data Structures of Lipid Marker Serum Concentrations in Multiple Sclerosis Patients Differ from Those in Healthy Subjects.

PubMed

Lötsch, Jörn; Thrun, Michael; Lerch, Florian; Brunkhorst, Robert; Schiffmann, Susanne; Thomas, Dominique; Tegder, Irmgard; Geisslinger, Gerd; Ultsch, Alfred

2017-06-07

Lipid metabolism has been suggested to be a major pathophysiological mechanism of multiple sclerosis (MS). With the increasing knowledge about lipid signaling, acquired data become increasingly complex making bioinformatics necessary in lipid research. We used unsupervised machine-learning to analyze lipid marker serum concentrations, pursuing the hypothesis that for the most relevant markers the emerging data structures will coincide with the diagnosis of MS. Machine learning was implemented as emergent self-organizing feature maps (ESOM) combined with the U*-matrix visualization technique. The data space consisted of serum concentrations of three main classes of lipid markers comprising eicosanoids ( d = 11 markers), ceramides ( d = 10), and lyosophosphatidic acids ( d = 6). They were analyzed in cohorts of MS patients ( n = 102) and healthy subjects ( n = 301). Clear data structures in the high-dimensional data space were observed in eicosanoid and ceramides serum concentrations whereas no clear structure could be found in lysophosphatidic acid concentrations. With ceramide concentrations, the structures that had emerged from unsupervised machine-learning almost completely overlapped with the known grouping of MS patients versus healthy subjects. This was only partly provided by eicosanoid serum concentrations. Thus, unsupervised machine-learning identified distinct data structures of bioactive lipid serum concentrations. These structures could be superimposed with the known grouping of MS patients versus healthy subjects, which was almost completely possible with ceramides. Therefore, based on the present analysis, ceramides are first-line candidates for further exploration as drug-gable targets or biomarkers in MS.

Unsupervised laparoscopic appendicectomy by surgical trainees is safe and time-effective.

PubMed

Wong, Kenneth; Duncan, Tristram; Pearson, Andrew

2007-07-01

Open appendicectomy is the traditional standard treatment for appendicitis. Laparoscopic appendicectomy is perceived as a procedure with greater potential for complications and longer operative times. This paper examines the hypothesis that unsupervised laparoscopic appendicectomy by surgical trainees is a safe and time-effective valid alternative. Medical records, operating theatre records and histopathology reports of all patients undergoing laparoscopic and open appendicectomy over a 15-month period in two hospitals within an area health service were retrospectively reviewed. Data were analysed to compare patient features, pathology findings, operative times, complications, readmissions and mortality between laparoscopic and open groups and between unsupervised surgical trainee operators versus consultant surgeon operators. A total of 143 laparoscopic and 222 open appendicectomies were reviewed. Unsupervised trainees performed 64% of the laparoscopic appendicectomies and 55% of the open appendicectomies. There were no significant differences in complication rates, readmissions, mortality and length of stay between laparoscopic and open appendicectomy groups or between trainee and consultant surgeon operators. Conversion rates (laparoscopic to open approach) were similar for trainees and consultants. Unsupervised senior surgical trainees did not take significantly longer to perform laparoscopic appendicectomy when compared to unsupervised trainee-performed open appendicectomy. Unsupervised laparoscopic appendicectomy by surgical trainees is safe and time-effective.

Novel Histogram Based Unsupervised Classification Technique to Determine Natural Classes From Biophysically Relevant Fit Parameters to Hyperspectral Data

DOE PAGES

McCann, Cooper; Repasky, Kevin S.; Morin, Mikindra; ...

2017-05-23

Hyperspectral image analysis has benefited from an array of methods that take advantage of the increased spectral depth compared to multispectral sensors; however, the focus of these developments has been on supervised classification methods. Lack of a priori knowledge regarding land cover characteristics can make unsupervised classification methods preferable under certain circumstances. An unsupervised classification technique is presented in this paper that utilizes physically relevant basis functions to model the reflectance spectra. These fit parameters used to generate the basis functions allow clustering based on spectral characteristics rather than spectral channels and provide both noise and data reduction. Histogram splittingmore » of the fit parameters is then used as a means of producing an unsupervised classification. Unlike current unsupervised classification techniques that rely primarily on Euclidian distance measures to determine similarity, the unsupervised classification technique uses the natural splitting of the fit parameters associated with the basis functions creating clusters that are similar in terms of physical parameters. The data set used in this work utilizes the publicly available data collected at Indian Pines, Indiana. This data set provides reference data allowing for comparisons of the efficacy of different unsupervised data analysis. The unsupervised histogram splitting technique presented in this paper is shown to be better than the standard unsupervised ISODATA clustering technique with an overall accuracy of 34.3/19.0% before merging and 40.9/39.2% after merging. Finally, this improvement is also seen as an improvement of kappa before/after merging of 24.8/30.5 for the histogram splitting technique compared to 15.8/28.5 for ISODATA.« less

Novel Histogram Based Unsupervised Classification Technique to Determine Natural Classes From Biophysically Relevant Fit Parameters to Hyperspectral Data

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

McCann, Cooper; Repasky, Kevin S.; Morin, Mikindra

Hyperspectral image analysis has benefited from an array of methods that take advantage of the increased spectral depth compared to multispectral sensors; however, the focus of these developments has been on supervised classification methods. Lack of a priori knowledge regarding land cover characteristics can make unsupervised classification methods preferable under certain circumstances. An unsupervised classification technique is presented in this paper that utilizes physically relevant basis functions to model the reflectance spectra. These fit parameters used to generate the basis functions allow clustering based on spectral characteristics rather than spectral channels and provide both noise and data reduction. Histogram splittingmore » of the fit parameters is then used as a means of producing an unsupervised classification. Unlike current unsupervised classification techniques that rely primarily on Euclidian distance measures to determine similarity, the unsupervised classification technique uses the natural splitting of the fit parameters associated with the basis functions creating clusters that are similar in terms of physical parameters. The data set used in this work utilizes the publicly available data collected at Indian Pines, Indiana. This data set provides reference data allowing for comparisons of the efficacy of different unsupervised data analysis. The unsupervised histogram splitting technique presented in this paper is shown to be better than the standard unsupervised ISODATA clustering technique with an overall accuracy of 34.3/19.0% before merging and 40.9/39.2% after merging. Finally, this improvement is also seen as an improvement of kappa before/after merging of 24.8/30.5 for the histogram splitting technique compared to 15.8/28.5 for ISODATA.« less

When and where do youths have sex? The potential role of adult supervision.

PubMed

Cohen, Deborah A; Farley, Thomas A; Taylor, Stephanie N; Martin, David H; Schuster, Mark A

2002-12-01

Interventions to reduce high-risk behaviors such as sex and substance use among youths have focused mainly on promoting abstinence, refusal skills, and negotiation skills, yet the frequency of high-risk behaviors among youths may also be influenced by opportunity, particularly the amount of time during which they are not supervised by adults. In this study, we examined when and where youths have sex and whether there is a relationship between unsupervised time and sex, sexually transmitted diseases (STDs), and substance use. A cross-sectional survey was conducted in 6 public high schools in an urban school district. Participants were 1065 boys and 969 girls from a school-based STD screening program. Ninety-eight percent of students were black, and 79% were in the free or reduced lunch program. Most students reported living with 1 parent only, primarily the mother (52%); only 27% lived in 2-parent families. Sexual activity, substance use, and the prevalence of gonorrhea or chlamydia as determined by a ligase-chain reaction test on a urine sample were measured. Fifty-six percent reported being home without an adult present 4 or more hours per day after school. There was no difference in the number of unsupervised after-school hours between children in 1- and 2-parent families. Fifty-five percent of boys and 41% of girls were participating in or planned to participate in after-school activities during the school year. Boys were more likely than girls to report having had sex for the first time before age 14 (42% vs 9%) and had a greater number of lifetime sex partners (mean: 4.2 vs 2.4 partners). Among the respondents who had had intercourse, 91% said that the last time had been in a home setting, including their own home (37%), their partner's home (43%), and a friend's home (12%), usually after school. Boys were more likely than girls to report having had sex in their own homes (43% vs 28%) and less likely than girls to report having had sex in their partner's homes (30% vs 59%). Fifty-six percent of youths who had had intercourse reported that the last time was on a weekday: 18% before 3:00, 17% between 3:00 and 6:00, and 21% after 6:00. There were no gender differences in the day of the week or time of day during which students reported having had intercourse. Youths who were unsupervised for 30 or more hours per week were more likely to be sexually active compared with those who were unsupervised for 5 hours a week or less (80% vs 68%). In addition, for boys, the greater the amount of unsupervised time, the higher the number of lifetime sex partners. Among girls but not among boys, sexual activity was associated with nonparticipation in after-school programs; 71% of those who were not participating in an after-school activity were sexually active compared with 59% of those who were participating. Tobacco and alcohol use were associated with unsupervised time among boys but not among girls. Boys who were unsupervised >5 hours per week after school were twice as likely to have gonorrhea or chlamydial infection as boys who were unsupervised for 5 hours or less. We found that substantial numbers of youths currently spend long periods of time without adult supervision and have limited opportunities to participate in after-school activities. More than half of sexually active youths reported that they had sex at home after school, and, particularly for boys, sexual-and drug-related risks increased as the amount of unsupervised time increased. As youths come of age, parents probably believe that it is appropriate to leave them increasingly on their own, and, accordingly, prevention approaches have concentrated on providing information and motivation for abstinence or safer sex. However, given the independent association between the amount of unsupervised time and sexual behaviors (with STD rates suggestive of particularly risky sexual behaviors) and substance use behaviors, it is worth considering increasing youth supervision, if not by parents, then by programs organized at schools organized at school or other community settings. Parents and community members should consider increasing opportunities for supervised activities to determine whether this will reduce risk-taking among youths.

Unsupervised Categorization in a Sample of Children with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Edwards, Darren J.; Perlman, Amotz; Reed, Phil

2012-01-01

Studies of supervised Categorization have demonstrated limited Categorization performance in participants with autism spectrum disorders (ASD), however little research has been conducted regarding unsupervised Categorization in this population. This study explored unsupervised Categorization using two stimulus sets that differed in their…

Unsupervised Deep Hashing With Pseudo Labels for Scalable Image Retrieval.

PubMed

Zhang, Haofeng; Liu, Li; Long, Yang; Shao, Ling

2018-04-01

In order to achieve efficient similarity searching, hash functions are designed to encode images into low-dimensional binary codes with the constraint that similar features will have a short distance in the projected Hamming space. Recently, deep learning-based methods have become more popular, and outperform traditional non-deep methods. However, without label information, most state-of-the-art unsupervised deep hashing (DH) algorithms suffer from severe performance degradation for unsupervised scenarios. One of the main reasons is that the ad-hoc encoding process cannot properly capture the visual feature distribution. In this paper, we propose a novel unsupervised framework that has two main contributions: 1) we convert the unsupervised DH model into supervised by discovering pseudo labels; 2) the framework unifies likelihood maximization, mutual information maximization, and quantization error minimization so that the pseudo labels can maximumly preserve the distribution of visual features. Extensive experiments on three popular data sets demonstrate the advantages of the proposed method, which leads to significant performance improvement over the state-of-the-art unsupervised hashing algorithms.

Spatiotemporal information during unsupervised learning enhances viewpoint invariant object recognition

PubMed Central

Tian, Moqian; Grill-Spector, Kalanit

2015-01-01

Recognizing objects is difficult because it requires both linking views of an object that can be different and distinguishing objects with similar appearance. Interestingly, people can learn to recognize objects across views in an unsupervised way, without feedback, just from the natural viewing statistics. However, there is intense debate regarding what information during unsupervised learning is used to link among object views. Specifically, researchers argue whether temporal proximity, motion, or spatiotemporal continuity among object views during unsupervised learning is beneficial. Here, we untangled the role of each of these factors in unsupervised learning of novel three-dimensional (3-D) objects. We found that after unsupervised training with 24 object views spanning a 180° view space, participants showed significant improvement in their ability to recognize 3-D objects across rotation. Surprisingly, there was no advantage to unsupervised learning with spatiotemporal continuity or motion information than training with temporal proximity. However, we discovered that when participants were trained with just a third of the views spanning the same view space, unsupervised learning via spatiotemporal continuity yielded significantly better recognition performance on novel views than learning via temporal proximity. These results suggest that while it is possible to obtain view-invariant recognition just from observing many views of an object presented in temporal proximity, spatiotemporal information enhances performance by producing representations with broader view tuning than learning via temporal association. Our findings have important implications for theories of object recognition and for the development of computational algorithms that learn from examples. PMID:26024454

Predicting category intuitiveness with the rational model, the simplicity model, and the generalized context model.

PubMed

Pothos, Emmanuel M; Bailey, Todd M

2009-07-01

Naïve observers typically perceive some groupings for a set of stimuli as more intuitive than others. The problem of predicting category intuitiveness has been historically considered the remit of models of unsupervised categorization. In contrast, this article develops a measure of category intuitiveness from one of the most widely supported models of supervised categorization, the generalized context model (GCM). Considering different category assignments for a set of instances, the authors asked how well the GCM can predict the classification of each instance on the basis of all the other instances. The category assignment that results in the smallest prediction error is interpreted as the most intuitive for the GCM-the authors refer to this way of applying the GCM as "unsupervised GCM." The authors systematically compared predictions of category intuitiveness from the unsupervised GCM and two models of unsupervised categorization: the simplicity model and the rational model. The unsupervised GCM compared favorably with the simplicity model and the rational model. This success of the unsupervised GCM illustrates that the distinction between supervised and unsupervised categorization may need to be reconsidered. However, no model emerged as clearly superior, indicating that there is more work to be done in understanding and modeling category intuitiveness.

Machine-Learned Data Structures of Lipid Marker Serum Concentrations in Multiple Sclerosis Patients Differ from Those in Healthy Subjects

PubMed Central

Lötsch, Jörn; Thrun, Michael; Lerch, Florian; Brunkhorst, Robert; Schiffmann, Susanne; Thomas, Dominique; Tegder, Irmgard; Geisslinger, Gerd; Ultsch, Alfred

2017-01-01

Lipid signaling has been suggested to be a major pathophysiological mechanism of multiple sclerosis (MS). With the increasing knowledge about lipid signaling, acquired data become increasingly complex making bioinformatics necessary in lipid research. We used unsupervised machine-learning to analyze lipid marker serum concentrations, pursuing the hypothesis that for the most relevant markers the emerging data structures will coincide with the diagnosis of MS. Machine learning was implemented as emergent self-organizing feature maps (ESOM) combined with the U*-matrix visualization technique. The data space consisted of serum concentrations of three main classes of lipid markers comprising eicosanoids (d = 11 markers), ceramides (d = 10), and lyosophosphatidic acids (d = 6). They were analyzed in cohorts of MS patients (n = 102) and healthy subjects (n = 301). Clear data structures in the high-dimensional data space were observed in eicosanoid and ceramides serum concentrations whereas no clear structure could be found in lysophosphatidic acid concentrations. With ceramide concentrations, the structures that had emerged from unsupervised machine-learning almost completely overlapped with the known grouping of MS patients versus healthy subjects. This was only partly provided by eicosanoid serum concentrations. Thus, unsupervised machine-learning identified distinct data structures of bioactive lipid serum concentrations. These structures could be superimposed with the known grouping of MS patients versus healthy subjects, which was almost completely possible with ceramides. Therefore, based on the present analysis, ceramides are first-line candidates for further exploration as drug-gable targets or biomarkers in MS. PMID:28590455

The influence of unsupervised time on elementary school children at high risk for inattention and problem behaviors.

PubMed

Na, Kyoung-Sae; Lee, Soyoung Irene; Hong, Hyun Ju; Oh, Myoung-Ja; Bahn, Geon Ho; Ha, Kyunghee; Shin, Yun Mi; Song, Jungeun; Park, Eun Jin; Yoo, Heejung; Kim, Hyunsoo; Kyung, Yun-Mi

2014-06-01

In the last few decades, changing socioeconomic and family structures have increasingly left children alone without adult supervision. Carefully prepared and limited periods of unsupervised time are not harmful for children. However, long unsupervised periods have harmful effects, particularly for those children at high risk for inattention and problem behaviors. In this study, we examined the influence of unsupervised time on behavior problems by studying a sample of elementary school children at high risk for inattention and problem behaviors. The study analyzed data from the Children's Mental Health Promotion Project, which was conducted in collaboration with education, government, and mental health professionals. The child behavior checklist (CBCL) was administered to assess problem behaviors among first- and fourth-grade children. Multivariate logistic regression analysis was used to evaluate the influence of unsupervised time on children's behavior. A total of 3,270 elementary school children (1,340 first-graders and 1,930 fourth-graders) were available for this study; 1,876 of the 3,270 children (57.4%) reportedly spent a significant amount of time unsupervised during the day. Unsupervised time that exceeded more than 2h per day increased the risk of delinquency, aggressive behaviors, and somatic complaints, as well as externalizing and internalizing problems. Carefully planned afterschool programming and care should be provided to children at high risk for inattention and problem behaviors. Also, a more comprehensive approach is needed to identify the possible mechanisms by which unsupervised time aggravates behavior problems in children predisposed for these behaviors. Copyright © 2013 Elsevier Ltd. All rights reserved.

Unsupervised self-care predicts conduct problems: The moderating roles of hostile aggression and gender.

PubMed

Atherton, Olivia E; Schofield, Thomas J; Sitka, Angela; Conger, Rand D; Robins, Richard W

2016-04-01

Despite widespread speculation about the detrimental effect of unsupervised self-care on adolescent outcomes, little is known about which children are particularly prone to problem behaviors when left at home without adult supervision. The present research used data from a longitudinal study of 674 Mexican-origin children residing in the United States to examine the prospective effect of unsupervised self-care on conduct problems, and the moderating roles of hostile aggression and gender. Results showed that unsupervised self-care was related to increases over time in conduct problems such as lying, stealing, and bullying. However, unsupervised self-care only led to conduct problems for boys and for children with an aggressive temperament. The main and interactive effects held for both mother-reported and observational-rated hostile aggression and after controlling for potential confounds. Copyright © 2016 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

78 FR 55728 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

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2013-09-11

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Computational discovery of pathway-level genetic vulnerabilities in non-small-cell lung cancer | Office of Cancer Genomics

Cancer.gov

Novel approaches are needed for discovery of targeted therapies for non-small-cell lung cancer (NSCLC) that are specific to certain patients. Whole genome RNAi screening of lung cancer cell lines provides an ideal source for determining candidate drug targets. Unsupervised learning algorithms uncovered patterns of differential vulnerability across lung cancer cell lines to loss of functionally related genes. Such genetic vulnerabilities represent candidate targets for therapy and are found to be involved in splicing, translation and protein folding.

Unsupervised universal steganalyzer for high-dimensional steganalytic features

NASA Astrophysics Data System (ADS)

Hou, Xiaodan; Zhang, Tao

2016-11-01

The research in developing steganalytic features has been highly successful. These features are extremely powerful when applied to supervised binary classification problems. However, they are incompatible with unsupervised universal steganalysis because the unsupervised method cannot distinguish embedding distortion from varying levels of noises caused by cover variation. This study attempts to alleviate the problem by introducing similarity retrieval of image statistical properties (SRISP), with the specific aim of mitigating the effect of cover variation on the existing steganalytic features. First, cover images with some statistical properties similar to those of a given test image are searched from a retrieval cover database to establish an aided sample set. Then, unsupervised outlier detection is performed on a test set composed of the given test image and its aided sample set to determine the type (cover or stego) of the given test image. Our proposed framework, called SRISP-aided unsupervised outlier detection, requires no training. Thus, it does not suffer from model mismatch mess. Compared with prior unsupervised outlier detectors that do not consider SRISP, the proposed framework not only retains the universality but also exhibits superior performance when applied to high-dimensional steganalytic features.

Video mining using combinations of unsupervised and supervised learning techniques

NASA Astrophysics Data System (ADS)

Divakaran, Ajay; Miyahara, Koji; Peker, Kadir A.; Radhakrishnan, Regunathan; Xiong, Ziyou

2003-12-01

We discuss the meaning and significance of the video mining problem, and present our work on some aspects of video mining. A simple definition of video mining is unsupervised discovery of patterns in audio-visual content. Such purely unsupervised discovery is readily applicable to video surveillance as well as to consumer video browsing applications. We interpret video mining as content-adaptive or "blind" content processing, in which the first stage is content characterization and the second stage is event discovery based on the characterization obtained in stage 1. We discuss the target applications and find that using a purely unsupervised approach are too computationally complex to be implemented on our product platform. We then describe various combinations of unsupervised and supervised learning techniques that help discover patterns that are useful to the end-user of the application. We target consumer video browsing applications such as commercial message detection, sports highlights extraction etc. We employ both audio and video features. We find that supervised audio classification combined with unsupervised unusual event discovery enables accurate supervised detection of desired events. Our techniques are computationally simple and robust to common variations in production styles etc.

The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act.

PubMed

Johnson, Matthew W; Griffiths, Roland R; Hendricks, Peter S; Henningfield, Jack E

2018-06-05

This review assesses the abuse potential of medically-administered psilocybin, following the structure of the 8 factors of the US Controlled Substances Act (CSA). Research suggests the potential safety and efficacy of psilocybin in treating cancer-related psychiatric distress and substance use disorders, setting the occasion for this review. A more extensive assessment of abuse potential according to an 8-factor analysis would eventually be required to guide appropriate schedule placement. Psilocybin, like other 5-HT2A agonist classic psychedelics, has limited reinforcing effects, supporting marginal, transient non-human self-administration. Nonetheless, mushrooms with variable psilocybin content are used illicitly, with a few lifetime use occasions being normative among users. Potential harms include dangerous behavior in unprepared, unsupervised users, and exacerbation of mental illness in those with or predisposed to psychotic disorders. However, scope of use and associated harms are low compared to prototypical abused drugs, and the medical model addresses these concerns with dose control, patient screening, preparation and follow-up, and session supervision in a medical facility. (1) psilocybin has an abuse potential appropriate for CSA scheduling if approved as medicine; (2) psilocybin can provide therapeutic benefits that may support the development of an approvable New Drug Application (NDA) but further studies are required which this review describes; (3) adverse effects of medical psilocybin are manageable when administered according to risk management approaches; and (4) although further study is required, this review suggests that placement in Schedule IV may be appropriate if a psilocybin-containing medicine is approved. Copyright © 2018. Published by Elsevier Ltd.

Minimizing drug misuse among elders: a proposal.

PubMed Central

Craig, J A; Eves, G B

1987-01-01

This proposal is aimed at reducing the risk of adverse drug interactions that may occur when over-the-counter (OTC) preparations are taken in conjunction with prescription drugs in an unsupervised regimen. Such polymedicating is practiced widely among the elderly. A pilot program would be implemented over 12 months at three drugstores of a major retail chain. A barcode-based computer system would be used to identify potential adverse drug interactions for elderly customers. All volunteers admitted to the study, controls and subjects, would agree to buy all their medications, prescriptions and OTC, at the participating pharmacies. In return, the volunteers would receive discounts of 25 percent on prescription and OTC drugs and 10 percent on vitamins. Study subjects (N = 375) would carry barcoded identification (BID) cards that would activate the computerized program to assess each purchase for compatibility with their other medications; controls (N = 375) would carry "dummy" BID cards that would prompt the computer to approve all drug purchases. A final comparison of the subjects with the controls, as well as with a sample of elderly residents selected randomly from the community, would determine whether such a computerized, commercially based drug use review system could reduce the potential for adverse interactions between OTC and prescription drugs among the elderly. PMID:3101129

Multi-Omics Factor Analysis-a framework for unsupervised integration of multi-omics data sets.

PubMed

Argelaguet, Ricard; Velten, Britta; Arnol, Damien; Dietrich, Sascha; Zenz, Thorsten; Marioni, John C; Buettner, Florian; Huber, Wolfgang; Stegle, Oliver

2018-06-20

Multi-omics studies promise the improved characterization of biological processes across molecular layers. However, methods for the unsupervised integration of the resulting heterogeneous data sets are lacking. We present Multi-Omics Factor Analysis (MOFA), a computational method for discovering the principal sources of variation in multi-omics data sets. MOFA infers a set of (hidden) factors that capture biological and technical sources of variability. It disentangles axes of heterogeneity that are shared across multiple modalities and those specific to individual data modalities. The learnt factors enable a variety of downstream analyses, including identification of sample subgroups, data imputation and the detection of outlier samples. We applied MOFA to a cohort of 200 patient samples of chronic lymphocytic leukaemia, profiled for somatic mutations, RNA expression, DNA methylation and ex vivo drug responses. MOFA identified major dimensions of disease heterogeneity, including immunoglobulin heavy-chain variable region status, trisomy of chromosome 12 and previously underappreciated drivers, such as response to oxidative stress. In a second application, we used MOFA to analyse single-cell multi-omics data, identifying coordinated transcriptional and epigenetic changes along cell differentiation. © 2018 The Authors. Published under the terms of the CC BY 4.0 license.

Recapitulation of Ayurveda constitution types by machine learning of phenotypic traits.

PubMed

Tiwari, Pradeep; Kutum, Rintu; Sethi, Tavpritesh; Shrivastava, Ankita; Girase, Bhushan; Aggarwal, Shilpi; Patil, Rutuja; Agarwal, Dhiraj; Gautam, Pramod; Agrawal, Anurag; Dash, Debasis; Ghosh, Saurabh; Juvekar, Sanjay; Mukerji, Mitali; Prasher, Bhavana

2017-01-01

In Ayurveda system of medicine individuals are classified into seven constitution types, "Prakriti", for assessing disease susceptibility and drug responsiveness. Prakriti evaluation involves clinical examination including questions about physiological and behavioural traits. A need was felt to develop models for accurately predicting Prakriti classes that have been shown to exhibit molecular differences. The present study was carried out on data of phenotypic attributes in 147 healthy individuals of three extreme Prakriti types, from a genetically homogeneous population of Western India. Unsupervised and supervised machine learning approaches were used to infer inherent structure of the data, and for feature selection and building classification models for Prakriti respectively. These models were validated in a North Indian population. Unsupervised clustering led to emergence of three natural clusters corresponding to three extreme Prakriti classes. The supervised modelling approaches could classify individuals, with distinct Prakriti types, in the training and validation sets. This study is the first to demonstrate that Prakriti types are distinct verifiable clusters within a multidimensional space of multiple interrelated phenotypic traits. It also provides a computational framework for predicting Prakriti classes from phenotypic attributes. This approach may be useful in precision medicine for stratification of endophenotypes in healthy and diseased populations.

76 FR 82311 - Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good...

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2011-12-30

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Chemical reaction vector embeddings: towards predicting drug metabolism in the human gut microbiome.

PubMed

Mallory, Emily K; Acharya, Ambika; Rensi, Stefano E; Turnbaugh, Peter J; Bright, Roselie A; Altman, Russ B

2018-01-01

Bacteria in the human gut have the ability to activate, inactivate, and reactivate drugs with both intended and unintended effects. For example, the drug digoxin is reduced to the inactive metabolite dihydrodigoxin by the gut Actinobacterium E. lenta, and patients colonized with high levels of drug metabolizing strains may have limited response to the drug. Understanding the complete space of drugs that are metabolized by the human gut microbiome is critical for predicting bacteria-drug relationships and their effects on individual patient response. Discovery and validation of drug metabolism via bacterial enzymes has yielded >50 drugs after nearly a century of experimental research. However, there are limited computational tools for screening drugs for potential metabolism by the gut microbiome. We developed a pipeline for comparing and characterizing chemical transformations using continuous vector representations of molecular structure learned using unsupervised representation learning. We applied this pipeline to chemical reaction data from MetaCyc to characterize the utility of vector representations for chemical reaction transformations. After clustering molecular and reaction vectors, we performed enrichment analyses and queries to characterize the space. We detected enriched enzyme names, Gene Ontology terms, and Enzyme Consortium (EC) classes within reaction clusters. In addition, we queried reactions against drug-metabolite transformations known to be metabolized by the human gut microbiome. The top results for these known drug transformations contained similar substructure modifications to the original drug pair. This work enables high throughput screening of drugs and their resulting metabolites against chemical reactions common to gut bacteria.

76 FR 55928 - Food and Drug Administration Health Professional Organizations Conference

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2010-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0142] Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...

Best friends' interactions and substance use: The role of friend pressure and unsupervised co-deviancy.

PubMed

Tsakpinoglou, Florence; Poulin, François

2017-10-01

Best friends exert a substantial influence on rising alcohol and marijuana use during adolescence. Two mechanisms occurring within friendship - friend pressure and unsupervised co-deviancy - may partially capture the way friends influence one another. The current study aims to: (1) examine the psychometric properties of a new instrument designed to assess pressure from a youth's best friend and unsupervised co-deviancy; (2) investigate the relative contribution of these processes to alcohol and marijuana use; and (3) determine whether gender moderates these associations. Data were collected through self-report questionnaires completed by 294 Canadian youths (62% female) across two time points (ages 15-16). Principal component analysis yielded a two-factor solution corresponding to friend pressure and unsupervised co-deviancy. Logistic regressions subsequently showed that unsupervised co-deviancy was predictive of an increase in marijuana use one year later. Neither process predicted an increase in alcohol use. Results did not differ as a function of gender. Copyright © 2017 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

76 FR 6477 - Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...

An unsupervised classification approach for analysis of Landsat data to monitor land reclamation in Belmont county, Ohio

NASA Technical Reports Server (NTRS)

Brumfield, J. O.; Bloemer, H. H. L.; Campbell, W. J.

1981-01-01

Two unsupervised classification procedures for analyzing Landsat data used to monitor land reclamation in a surface mining area in east central Ohio are compared for agreement with data collected from the corresponding locations on the ground. One procedure is based on a traditional unsupervised-clustering/maximum-likelihood algorithm sequence that assumes spectral groupings in the Landsat data in n-dimensional space; the other is based on a nontraditional unsupervised-clustering/canonical-transformation/clustering algorithm sequence that not only assumes spectral groupings in n-dimensional space but also includes an additional feature-extraction technique. It is found that the nontraditional procedure provides an appreciable improvement in spectral groupings and apparently increases the level of accuracy in the classification of land cover categories.

Random Forest Segregation of Drug Responses May Define Regions of Biological Significance.

PubMed

Bukhari, Qasim; Borsook, David; Rudin, Markus; Becerra, Lino

2016-01-01

The ability to assess brain responses in unsupervised manner based on fMRI measure has remained a challenge. Here we have applied the Random Forest (RF) method to detect differences in the pharmacological MRI (phMRI) response in rats to treatment with an analgesic drug (buprenorphine) as compared to control (saline). Three groups of animals were studied: two groups treated with different doses of the opioid buprenorphine, low (LD), and high dose (HD), and one receiving saline. PhMRI responses were evaluated in 45 brain regions and RF analysis was applied to allocate rats to the individual treatment groups. RF analysis was able to identify drug effects based on differential phMRI responses in the hippocampus, amygdala, nucleus accumbens, superior colliculus, and the lateral and posterior thalamus for drug vs. saline. These structures have high levels of mu opioid receptors. In addition these regions are involved in aversive signaling, which is inhibited by mu opioids. The results demonstrate that buprenorphine mediated phMRI responses comprise characteristic features that allow a supervised differentiation from placebo treated rats as well as the proper allocation to the respective drug dose group using the RF method, a method that has been successfully applied in clinical studies.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0590] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

77 FR 21784 - Science Board to the Food and Drug Administration; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No FDA-2012-N-0001] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science...

78 FR 30317 - Science Board to the Food and Drug Administration; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-22

...] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The...

78 FR 6332 - Science Board to the Food and Drug Administration; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-30

...] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The...

77 FR 51031 - Science Board to the Food and Drug Administration; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-23

...] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The...

76 FR 25358 - 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food...

77 FR 52744 - Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration's (FDA) Office of Orphan Products Development...

76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY Food and Drug Administration Privacy Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record...

78 FR 9928 - Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-12

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0124] Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: To assist the Food...

21 CFR 7.45 - Food and Drug Administration-requested recall.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Industry Responsibilities § 7.45 Food and Drug Administration-requested recall. (a) The Commissioner of... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration-requested recall. 7.45 Section 7.45 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 20.1 - Testimony by Food and Drug Administration employees.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Testimony by Food and Drug Administration employees. 20.1 Section 20.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... laws administered by the Food and Drug Administration, shall give any testimony before any tribunal...

Supervised versus unsupervised categorization: two sides of the same coin?

PubMed

Pothos, Emmanuel M; Edwards, Darren J; Perlman, Amotz

2011-09-01

Supervised and unsupervised categorization have been studied in separate research traditions. A handful of studies have attempted to explore a possible convergence between the two. The present research builds on these studies, by comparing the unsupervised categorization results of Pothos et al. ( 2011 ; Pothos et al., 2008 ) with the results from two procedures of supervised categorization. In two experiments, we tested 375 participants with nine different stimulus sets and examined the relation between ease of learning of a classification, memory for a classification, and spontaneous preference for a classification. After taking into account the role of the number of category labels (clusters) in supervised learning, we found the three variables to be closely associated with each other. Our results provide encouragement for researchers seeking unified theoretical explanations for supervised and unsupervised categorization, but raise a range of challenging theoretical questions.

28 CFR 0.102 - Drug enforcement policy coordination.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Drug enforcement policy coordination. 0... JUSTICE Drug Enforcement Administration § 0.102 Drug enforcement policy coordination. The Administrator of the Drug Enforcement Administration shall report to the Attorney General, through the Deputy Attorney...

28 CFR 0.102 - Drug enforcement policy coordination.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Drug enforcement policy coordination. 0... JUSTICE Drug Enforcement Administration § 0.102 Drug enforcement policy coordination. The Administrator of the Drug Enforcement Administration shall report to the Attorney General, through the Deputy Attorney...

28 CFR 0.102 - Drug enforcement policy coordination.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Drug enforcement policy coordination. 0... JUSTICE Drug Enforcement Administration § 0.102 Drug enforcement policy coordination. The Administrator of the Drug Enforcement Administration shall report to the Attorney General, through the Deputy Attorney...

78 FR 35937 - Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug...

78 FR 15019 - Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0196] Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice, request for comments. SUMMARY: The Food and...

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 20.2 - Production of records by Food and Drug Administration employees.

Code of Federal Regulations, 2010 CFR

2010-04-01

... upon an officer or employee of the Food and Drug Administration commanding the production of any record... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Production of records by Food and Drug Administration employees. 20.2 Section 20.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

Unsupervised automated high throughput phenotyping of RNAi time-lapse movies.

PubMed

Failmezger, Henrik; Fröhlich, Holger; Tresch, Achim

2013-10-04

Gene perturbation experiments in combination with fluorescence time-lapse cell imaging are a powerful tool in reverse genetics. High content applications require tools for the automated processing of the large amounts of data. These tools include in general several image processing steps, the extraction of morphological descriptors, and the grouping of cells into phenotype classes according to their descriptors. This phenotyping can be applied in a supervised or an unsupervised manner. Unsupervised methods are suitable for the discovery of formerly unknown phenotypes, which are expected to occur in high-throughput RNAi time-lapse screens. We developed an unsupervised phenotyping approach based on Hidden Markov Models (HMMs) with multivariate Gaussian emissions for the detection of knockdown-specific phenotypes in RNAi time-lapse movies. The automated detection of abnormal cell morphologies allows us to assign a phenotypic fingerprint to each gene knockdown. By applying our method to the Mitocheck database, we show that a phenotypic fingerprint is indicative of a gene's function. Our fully unsupervised HMM-based phenotyping is able to automatically identify cell morphologies that are specific for a certain knockdown. Beyond the identification of genes whose knockdown affects cell morphology, phenotypic fingerprints can be used to find modules of functionally related genes.

Unsupervised learning on scientific ocean drilling datasets from the South China Sea

NASA Astrophysics Data System (ADS)

Tse, Kevin C.; Chiu, Hon-Chim; Tsang, Man-Yin; Li, Yiliang; Lam, Edmund Y.

2018-06-01

Unsupervised learning methods were applied to explore data patterns in multivariate geophysical datasets collected from ocean floor sediment core samples coming from scientific ocean drilling in the South China Sea. Compared to studies on similar datasets, but using supervised learning methods which are designed to make predictions based on sample training data, unsupervised learning methods require no a priori information and focus only on the input data. In this study, popular unsupervised learning methods including K-means, self-organizing maps, hierarchical clustering and random forest were coupled with different distance metrics to form exploratory data clusters. The resulting data clusters were externally validated with lithologic units and geologic time scales assigned to the datasets by conventional methods. Compact and connected data clusters displayed varying degrees of correspondence with existing classification by lithologic units and geologic time scales. K-means and self-organizing maps were observed to perform better with lithologic units while random forest corresponded best with geologic time scales. This study sets a pioneering example of how unsupervised machine learning methods can be used as an automatic processing tool for the increasingly high volume of scientific ocean drilling data.

An Efficient Optimization Method for Solving Unsupervised Data Classification Problems.

PubMed

Shabanzadeh, Parvaneh; Yusof, Rubiyah

2015-01-01

Unsupervised data classification (or clustering) analysis is one of the most useful tools and a descriptive task in data mining that seeks to classify homogeneous groups of objects based on similarity and is used in many medical disciplines and various applications. In general, there is no single algorithm that is suitable for all types of data, conditions, and applications. Each algorithm has its own advantages, limitations, and deficiencies. Hence, research for novel and effective approaches for unsupervised data classification is still active. In this paper a heuristic algorithm, Biogeography-Based Optimization (BBO) algorithm, was adapted for data clustering problems by modifying the main operators of BBO algorithm, which is inspired from the natural biogeography distribution of different species. Similar to other population-based algorithms, BBO algorithm starts with an initial population of candidate solutions to an optimization problem and an objective function that is calculated for them. To evaluate the performance of the proposed algorithm assessment was carried on six medical and real life datasets and was compared with eight well known and recent unsupervised data classification algorithms. Numerical results demonstrate that the proposed evolutionary optimization algorithm is efficient for unsupervised data classification.

Semi-supervised and unsupervised extreme learning machines.

PubMed

Huang, Gao; Song, Shiji; Gupta, Jatinder N D; Wu, Cheng

2014-12-01

Extreme learning machines (ELMs) have proven to be efficient and effective learning mechanisms for pattern classification and regression. However, ELMs are primarily applied to supervised learning problems. Only a few existing research papers have used ELMs to explore unlabeled data. In this paper, we extend ELMs for both semi-supervised and unsupervised tasks based on the manifold regularization, thus greatly expanding the applicability of ELMs. The key advantages of the proposed algorithms are as follows: 1) both the semi-supervised ELM (SS-ELM) and the unsupervised ELM (US-ELM) exhibit learning capability and computational efficiency of ELMs; 2) both algorithms naturally handle multiclass classification or multicluster clustering; and 3) both algorithms are inductive and can handle unseen data at test time directly. Moreover, it is shown in this paper that all the supervised, semi-supervised, and unsupervised ELMs can actually be put into a unified framework. This provides new perspectives for understanding the mechanism of random feature mapping, which is the key concept in ELM theory. Empirical study on a wide range of data sets demonstrates that the proposed algorithms are competitive with the state-of-the-art semi-supervised or unsupervised learning algorithms in terms of accuracy and efficiency.

Administration costs of intravenous biologic drugs for rheumatoid arthritis.

PubMed

Soini, Erkki J; Leussu, Miina; Hallinen, Taru

2013-01-01

Cost-effectiveness studies explicitly reporting infusion times, drug-specific administration costs for infusions or real-payer intravenous drug cost are few in number. Yet, administration costs for infusions are needed in the health economic evaluations assessing intravenously-administered drugs. To estimate the drug-specific administration and total cost of biologic intravenous rheumatoid arthritis (RA) drugs in the adult population and to compare the obtained costs with published cost estimates. Cost price data for the infusions and drugs were systematically collected from the 2011 Finnish price lists. All Finnish hospitals with available price lists were included. Drug administration and total costs (administration cost + drug price) per infusion were analysed separately from the public health care payer's perspective. Further adjustments for drug brand, dose, and hospital type were done using regression methods in order to improve the comparability between drugs. Annual expected drug administration and total costs were estimated. A literature search not limited to RA was performed to obtain the per infusion administration cost estimates used in publications. The published costs were converted to Finnish values using base-year purchasing power parities and indexing to the year 2011. Information from 19 (95%) health districts was obtained (107 analysable prices out of 176 observations). The average drug administration cost for infliximab, rituximab, abatacept, and tocilizumab infusion in RA were €355.91; €561.21; €334.00; and €293.96, respectively. The regression-adjusted (dose, hospital type; using semi-log ordinary least squares) mean administration costs for infliximab and rituximab infusions in RA were €289.12 (95% CI €222.61-375.48) and €542.28 (95% CI €307.23-957.09). The respective expected annual drug administration costs were €2312.96 for infliximab during the first year, €1879.28 for infliximab during the forthcoming years, and €1843.75 for rituximab. The obtained average administration costs per infusion were higher (1.8-3.3 times depending on the drug) than the previously published purchasing power adjusted and indexed average administration costs for infusions in RA. The administration costs of RA infusions vary between drugs, and more effort should be made to find realistic drug-specific estimates for cost-effectiveness evaluations. The frequent assumption of intravenous drug administration costs equalling outpatient visit cost can underestimate the costs.

76 FR 11490 - Withdrawal of Approval of New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0033... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... INFORMATION CONTACT: John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration...

Unsupervised chunking based on graph propagation from bilingual corpus.

PubMed

Zhu, Ling; Wong, Derek F; Chao, Lidia S

2014-01-01

This paper presents a novel approach for unsupervised shallow parsing model trained on the unannotated Chinese text of parallel Chinese-English corpus. In this approach, no information of the Chinese side is applied. The exploitation of graph-based label propagation for bilingual knowledge transfer, along with an application of using the projected labels as features in unsupervised model, contributes to a better performance. The experimental comparisons with the state-of-the-art algorithms show that the proposed approach is able to achieve impressive higher accuracy in terms of F-score.

An unsupervised classification technique for multispectral remote sensing data.

NASA Technical Reports Server (NTRS)

Su, M. Y.; Cummings, R. E.

1973-01-01

Description of a two-part clustering technique consisting of (a) a sequential statistical clustering, which is essentially a sequential variance analysis, and (b) a generalized K-means clustering. In this composite clustering technique, the output of (a) is a set of initial clusters which are input to (b) for further improvement by an iterative scheme. This unsupervised composite technique was employed for automatic classification of two sets of remote multispectral earth resource observations. The classification accuracy by the unsupervised technique is found to be comparable to that by traditional supervised maximum-likelihood classification techniques.

Unsupervised classification of earth resources data.

NASA Technical Reports Server (NTRS)

Su, M. Y.; Jayroe, R. R., Jr.; Cummings, R. E.

1972-01-01

A new clustering technique is presented. It consists of two parts: (a) a sequential statistical clustering which is essentially a sequential variance analysis and (b) a generalized K-means clustering. In this composite clustering technique, the output of (a) is a set of initial clusters which are input to (b) for further improvement by an iterative scheme. This unsupervised composite technique was employed for automatic classification of two sets of remote multispectral earth resource observations. The classification accuracy by the unsupervised technique is found to be comparable to that by existing supervised maximum liklihood classification technique.

Compliance with 14-day primaquine therapy for radical cure of vivax malaria--a randomized placebo-controlled trial comparing unsupervised with supervised treatment.

PubMed

Leslie, Toby; Rab, Mohammad Abdur; Ahmadzai, Hayat; Durrani, Naeem; Fayaz, Mohammad; Kolaczinski, Jan; Rowland, Mark

2004-03-01

The only available treatment that can eliminate the latent hypnozoite reservoir of vivax malaria is a 14 d course of primaquine (PQ). A potential problem with long-course chemotherapy is the issue of compliance after clinical symptoms have subsided. The present study, carried out at an Afghan refugee camp in Pakistan, between June 2000 and August 2001, compared 14 d treatment in supervised and unsupervised groups in which compliance was monitored by comparison of relapse rates. Clinical cases recruited by passive case detection were randomised by family to placebo, supervised, or unsupervised groups, and treated with chloroquine (25 mg/kg) over 3 days to eliminate erythrocytic stages. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency were excluded from the trial. Cases allocated to supervision were given directly observed treatment (0.25 mg PQ/kg body weight) once per day for 14 days. Cases allocated to the unsupervised group were provided with 14 PQ doses upon enrollment and strongly advised to complete the course. A total of 595 cases were enrolled. After 9 months of follow up PQ proved equally protective against further episodes of P. vivax in supervised (odds ratio 0.35, 95% CI 0.21-0.57) and unsupervised (odds ratio 0.37, 95% CI 0.23-0.59) groups as compared to placebo. All age groups on supervised or unsupervised treatment showed a similar degree of protection even though the risk of relapse decreased with age. The study showed that a presumed problem of poor compliance may be overcome with simple health messages even when the majority of individuals are illiterate and without formal education. Unsupervised treatment with 14-day PQ when combined with simple instruction can avert a significant amount of the morbidity associated with relapse in populations where G6PD deficiency is either absent or readily diagnosable.

True Zero-Training Brain-Computer Interfacing – An Online Study

PubMed Central

Kindermans, Pieter-Jan; Schreuder, Martijn; Schrauwen, Benjamin; Müller, Klaus-Robert; Tangermann, Michael

2014-01-01

Despite several approaches to realize subject-to-subject transfer of pre-trained classifiers, the full performance of a Brain-Computer Interface (BCI) for a novel user can only be reached by presenting the BCI system with data from the novel user. In typical state-of-the-art BCI systems with a supervised classifier, the labeled data is collected during a calibration recording, in which the user is asked to perform a specific task. Based on the known labels of this recording, the BCI's classifier can learn to decode the individual's brain signals. Unfortunately, this calibration recording consumes valuable time. Furthermore, it is unproductive with respect to the final BCI application, e.g. text entry. Therefore, the calibration period must be reduced to a minimum, which is especially important for patients with a limited concentration ability. The main contribution of this manuscript is an online study on unsupervised learning in an auditory event-related potential (ERP) paradigm. Our results demonstrate that the calibration recording can be bypassed by utilizing an unsupervised trained classifier, that is initialized randomly and updated during usage. Initially, the unsupervised classifier tends to make decoding mistakes, as the classifier might not have seen enough data to build a reliable model. Using a constant re-analysis of the previously spelled symbols, these initially misspelled symbols can be rectified posthoc when the classifier has learned to decode the signals. We compare the spelling performance of our unsupervised approach and of the unsupervised posthoc approach to the standard supervised calibration-based dogma for n = 10 healthy users. To assess the learning behavior of our approach, it is unsupervised trained from scratch three times per user. Even with the relatively low SNR of an auditory ERP paradigm, the results show that after a limited number of trials (30 trials), the unsupervised approach performs comparably to a classic supervised model. PMID:25068464

[Anatomophysiological bases of drug administration. Dosage forms and routes of administration].

PubMed

Carillo Norte, Juan Antonio; Gañán Presmanes, Yolanda

2010-12-01

The administration of the right dose to the right patient is of paramount importance to obtain an optimal drug response within the scope of clinical pharmacology and tailored medicine. The marketing of safer and more efficient drug entities, along with the development of new drug administration devices provide a major boost for the diagnosis and treatment of diseases, beyond our imagination. However dose adjustment is not enough to produced the desired effect, and drug therapy should include an appropriate route of drug administration. Currently, there are many different and sophisticated methods to incorporate drugs into the patients that nurses should be familiar with. When there is no contraindication, oral route of drug administration is of choice and most frequently used as a physiological pathway of drug intake.

A comparison of neural network and fuzzy clustering techniques in segmenting magnetic resonance images of the brain.

PubMed

Hall, L O; Bensaid, A M; Clarke, L P; Velthuizen, R P; Silbiger, M S; Bezdek, J C

1992-01-01

Magnetic resonance (MR) brain section images are segmented and then synthetically colored to give visual representations of the original data with three approaches: the literal and approximate fuzzy c-means unsupervised clustering algorithms, and a supervised computational neural network. Initial clinical results are presented on normal volunteers and selected patients with brain tumors surrounded by edema. Supervised and unsupervised segmentation techniques provide broadly similar results. Unsupervised fuzzy algorithms were visually observed to show better segmentation when compared with raw image data for volunteer studies. For a more complex segmentation problem with tumor/edema or cerebrospinal fluid boundary, where the tissues have similar MR relaxation behavior, inconsistency in rating among experts was observed, with fuzz-c-means approaches being slightly preferred over feedforward cascade correlation results. Various facets of both approaches, such as supervised versus unsupervised learning, time complexity, and utility for the diagnostic process, are compared.

Six weeks of unsupervised Nintendo Wii Fit gaming is effective at improving balance in independent older adults.

PubMed

Nicholson, Vaughan Patrick; McKean, Mark; Lowe, John; Fawcett, Christine; Burkett, Brendan

2015-01-01

To determine the effectiveness of unsupervised Nintendo Wii Fit balance training in older adults. Forty-one older adults were recruited from local retirement villages and educational settings to participate in a six-week two-group repeated measures study. The Wii group (n = 19, 75 ± 6 years) undertook 30 min of unsupervised Wii balance gaming three times per week in their retirement village while the comparison group (n = 22, 74 ± 5 years) continued with their usual exercise program. Participants' balance abilities were assessed pre- and postintervention. The Wii Fit group demonstrated significant improvements (P < .05) in timed up-and-go, left single-leg balance, lateral reach (left and right), and gait speed compared with the comparison group. Reported levels of enjoyment following game play increased during the study. Six weeks of unsupervised Wii balance training is an effective modality for improving balance in independent older adults.

Assessing the Linguistic Productivity of Unsupervised Deep Neural Networks

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

Phillips, Lawrence A.; Hodas, Nathan O.

Increasingly, cognitive scientists have demonstrated interest in applying tools from deep learning. One use for deep learning is in language acquisition where it is useful to know if a linguistic phenomenon can be learned through domain-general means. To assess whether unsupervised deep learning is appropriate, we first pose a smaller question: Can unsupervised neural networks apply linguistic rules productively, using them in novel situations. We draw from the literature on determiner/noun productivity by training an unsupervised, autoencoder network measuring its ability to combine nouns with determiners. Our simple autoencoder creates combinations it has not previously encountered, displaying a degree ofmore » overlap similar to actual children. While this preliminary work does not provide conclusive evidence for productivity, it warrants further investigation with more complex models. Further, this work helps lay the foundations for future collaboration between the deep learning and cognitive science communities.« less

21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and Drug Administration operates two public reading rooms. The Freedom of Information Staff's Public Reading Room is...

78 FR 6824 - Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

... Amyotrophic Lateral Sclerosis; Public Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA or the Agency) is... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0035...

21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and Drug Administration operates two public reading rooms. The Freedom of Information Staff's Public Reading Room is...

78 FR 51732 - The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug...

78 FR 36711 - Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

...: Food and Drug Administration, HHS. ACTION: Notification of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a public meeting regarding FDA's... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket Nos...

78 FR 21085 - Establishment of a Public Docket for Administrative Detention Under the Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-09

... Administration Safety and Innovation Act AGENCY: Food and Drug Administration, HHS. ACTION: Establishment of... authority with respect to drugs under the Food and Drug Administration Safety and Innovation Act (FDASIA....regulations.gov . Submit written comments to the Division of Dockets Management (HFA- 305), Food and Drug...

75 FR 386 - Memorandum of Understanding Between the United States Department of Health and Human Services...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0667... Services, Food and Drug Administration, Center for Drug Evaluation and Research and Northeastern University AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

75 FR 1274 - Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 [Docket No... AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration... Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276...

75 FR 13766 - Food and Drug Administration and Process Analytical Technology for Pharma Manufacturing: Food and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-23

... Administration--Partnering With Industry; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) is announcing a joint conference with... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001...

28 CFR Appendix B to Part 61 - Drug Enforcement Administration Procedures Relating to the Implementation of the National...

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Drug Enforcement Administration... ENVIRONMENTAL POLICY ACT Pt. 61, App. B Appendix B to Part 61—Drug Enforcement Administration Procedures.... This part applies to all organizational elements of the Drug Enforcement Administration [DEA]. 2...

An observational study of drug administration errors in a Malaysian hospital (study of drug administration errors).

PubMed

Chua, S S; Tea, M H; Rahman, M H A

2009-04-01

Drug administration errors were the second most frequent type of medication errors, after prescribing errors but the latter were often intercepted hence, administration errors were more probably to reach the patients. Therefore, this study was conducted to determine the frequency and types of drug administration errors in a Malaysian hospital ward. This is a prospective study that involved direct, undisguised observations of drug administrations in a hospital ward. A researcher was stationed in the ward under study for 15 days to observe all drug administrations which were recorded in a data collection form and then compared with the drugs prescribed for the patient. A total of 1118 opportunities for errors were observed and 127 administrations had errors. This gave an error rate of 11.4 % [95% confidence interval (CI) 9.5-13.3]. If incorrect time errors were excluded, the error rate reduced to 8.7% (95% CI 7.1-10.4). The most common types of drug administration errors were incorrect time (25.2%), followed by incorrect technique of administration (16.3%) and unauthorized drug errors (14.1%). In terms of clinical significance, 10.4% of the administration errors were considered as potentially life-threatening. Intravenous routes were more likely to be associated with an administration error than oral routes (21.3% vs. 7.9%, P < 0.001). The study indicates that the frequency of drug administration errors in developing countries such as Malaysia is similar to that in the developed countries. Incorrect time errors were also the most common type of drug administration errors. A non-punitive system of reporting medication errors should be established to encourage more information to be documented so that risk management protocol could be developed and implemented.

Response to Trauma in Haitian Youth at Risk

PubMed Central

Douyon, Richard; Marcelin, Louis Herns; Jean-Gilles, Michèle; Page, J. Bryan

2006-01-01

SUMMARY In order to characterize undesirable behavior (drug use, fighting, criminal activity) among Haitian youth at risk and determine the relationship between traumatic experience and that kind of behavior, investigators recruited 291 Haitian youths via networks of informal social relations in two zones of Miami/Dade County strongly idenitified with Haitian ethnicity. Each recruit responded to an interview schedule eliciting sociodemographic information and self-reported activities, including involvement in youth-dominated groups. They also reported traumatic experience. Clinicians administered CAPS to a subset of those respondents who self-reported traumatic experience. Staff ethnographers selected respondents for in-depth interviews and family studies to provide contextual depth for findings of the interview schedule and the CAPS assessments. Although traumatic experience may still play a role in mental health outcomes among children, childhood victimization among Haitian children does not appear to be related to the drug use and undesirable behaviors associated with unsupervised youth, including formation of gangs. PMID:16275637

Gym and tonic: a profile of 100 male steroid users.

PubMed Central

Evans, N A

1997-01-01

OBJECTIVE: To identify unsupervised anabolic steroid regimens used by athletes. METHODS: 100 athletes attending four gymnasia were surveyed using an anonymous self administered questionnaire. RESULTS: Anabolic steroid doses ranged from 250 to 3200 mg per week and users combined different drugs to achieve these doses. Injectable and oral preparations were used in cycles lasting four to 12 weeks. Eighty six per cent of users admitted to the regular use of drugs other than steroids for various reasons, including additional anabolic effects, the minimisation of steroid related side effects, and withdrawal symptoms. Acne, striae, and gynaecomastia were the most commonly reported subjective side effects. CONCLUSIONS: Multiple steroids are combined in megadoses and self administered in a cyclical fashion. Polypharmacy is practised by over 80% of steroid users. Skeletal muscle hypertrophy along with acne, striae, and gynaecomastia are frequent physical signs associated with steroid use. Images Figure 2 PMID:9132214

76 FR 61366 - Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247] Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase...: Food and Drug Administration, HHS. [[Page 61367

77 FR 60125 - Generic Drug Facilities, Sites and Organizations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1006] Generic Drug Facilities, Sites and Organizations AGENCY: Food and Drug Administration, HHS. ACTION: Notice of Requirement. SUMMARY: The Food and Drug Administration (FDA) is notifying generic drug facilities...

21 CFR 1316.10 - Administrative probable cause.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Administrative probable cause. 1316.10 Section 1316.10 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.10 Administrative probable cause. If the judge...

75 FR 73951 - Amendments to General Regulations of the Food and Drug Administration

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2010-11-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 14, and 17 [Docket No. FDA-2010-N-0560] RIN 0910-AG55 Amendments to General Regulations of the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule. SUMMARY: The Food and Drug...

75 FR 73984 - Amendments to General Regulations of the Food and Drug Administration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 14, and 17 [Docket No. FDA-2010-N-0560] RIN 0910-AG55 Amendments to General Regulations of the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0140] Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May Result in a Prescription Drug Shortage; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...

21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Administration records. 20.20 Section 20.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... the record will be so used, may be requested when: (1) The requested record is contained in a Privacy... Administration records. (a) The Food and Drug Administration will make the fullest possible disclosure of records...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-27

... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., and Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-09

... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0375...

77 FR 64346 - Nonprescription Drugs Advisory Committee; Amendment of Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-19

... for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Building 31... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Nonprescription Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION...

75 FR 1275 - New Animal Drugs; Ractopamine

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2009-N-0665] New Animal Drugs; Ractopamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

78 FR 22553 - Generic Drug Facilities, Sites, and Organizations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0391] Generic Drug Facilities, Sites, and Organizations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that the generic drug facility self...

75 FR 81455 - New Animal Drugs; Deslorelin

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 522 [Docket No. FDA-2010-N-0002] New Animal Drugs; Deslorelin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

76 FR 17025 - New Animal Drugs; Oxytetracycline

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 529 [Docket No. FDA-2011-N-0003] New Animal Drugs; Oxytetracycline AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

76 FR 57906 - New Animal Drugs; Gamithromycin

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 522 and 556 [Docket No. FDA-2011-N-0003] New Animal Drugs; Gamithromycin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

77 FR 32897 - New Animal Drugs; Change of Sponsor's Name

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-04

.... FDA-2012-N-0002] New Animal Drugs; Change of Sponsor's Name AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug... 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and...

Effects of sharing information on drug administration errors in pediatric wards: a pre–post intervention study

PubMed Central

Chua, Siew-Siang; Choo, Sim-Mei; Sulaiman, Che Zuraini; Omar, Asma; Thong, Meow-Keong

2017-01-01

Background and purpose Drug administration errors are more likely to reach the patient than other medication errors. The main aim of this study was to determine whether the sharing of information on drug administration errors among health care providers would reduce such problems. Patients and methods This study involved direct, undisguised observations of drug administrations in two pediatric wards of a major teaching hospital in Kuala Lumpur, Malaysia. This study consisted of two phases: Phase 1 (pre-intervention) and Phase 2 (post-intervention). Data were collected by two observers over a 40-day period in both Phase 1 and Phase 2 of the study. Both observers were pharmacy graduates: Observer 1 just completed her undergraduate pharmacy degree, whereas Observer 2 was doing her one-year internship as a provisionally registered pharmacist in the hospital under study. A drug administration error was defined as a discrepancy between the drug regimen received by the patient and that intended by the prescriber and also drug administration procedures that did not follow standard hospital policies and procedures. Results from Phase 1 of the study were analyzed, presented and discussed with the ward staff before commencement of data collection in Phase 2. Results A total of 1,284 and 1,401 doses of drugs were administered in Phase 1 and Phase 2, respectively. The rate of drug administration errors reduced significantly from Phase 1 to Phase 2 (44.3% versus 28.6%, respectively; P<0.001). Logistic regression analysis showed that the adjusted odds of drug administration errors in Phase 1 of the study were almost three times that in Phase 2 (P<0.001). The most common types of errors were incorrect administration technique and incorrect drug preparation. Nasogastric and intravenous routes of drug administration contributed significantly to the rate of drug administration errors. Conclusion This study showed that sharing of the types of errors that had occurred was significantly associated with a reduction in drug administration errors. PMID:28356748

76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-29

..., Advisory committees, Color additives, Drugs, Radiation protection. Therefore, under the Federal Food, Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 [Docket No... AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration...

21 CFR 20.107 - Food and Drug Administration manuals.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

21 CFR 20.107 - Food and Drug Administration manuals.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

21 CFR 20.107 - Food and Drug Administration manuals.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

21 CFR 20.107 - Food and Drug Administration manuals.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

76 FR 40808 - Oral Dosage Form New Animal Drugs; Amprolium

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-12

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Amprolium AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

76 FR 2807 - New Animal Drugs; Change of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 510 [Docket No. FDA-2010-N-0002] New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

76 FR 59023 - Oral Dosage Form New Animal Drugs; Tylosin

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

75 FR 79295 - New Animal Drugs; Mupirocin

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 524 [Docket No. FDA-2010-N-0002] New Animal Drugs; Mupirocin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

75 FR 67031 - Oral Dosage Form New Animal Drugs; Domperidone

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Domperidone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

77 FR 3927 - Oral Dosage Form New Animal Drugs; Deracoxib

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Deracoxib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

78 FR 22 - New Animal Drugs; Meloxicam; Nicarbazin

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 558 [Docket No. FDA-2012-N-0002] New Animal Drugs; Meloxicam; Nicarbazin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

76 FR 6326 - New Animal Drugs; Masitinib

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 516 [Docket No. FDA-2011-N-0003] New Animal Drugs; Masitinib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

77 FR 15960 - Oral Dosage Form New Animal Drugs; Pergolide

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Pergolide AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

76 FR 18648 - Oral Dosage Form New Animal Drugs; Robenacoxib

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Robenacoxib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

76 FR 78149 - Oral Dosage Form New Animal Drugs; Estriol

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Estriol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

21 CFR 20.107 - Food and Drug Administration manuals.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

77 FR 4224 - New Animal Drugs; Change of Sponsor's Name

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-27

.... FDA-2011-N-0003] New Animal Drugs; Change of Sponsor's Name AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug.... 801-808. List of Subjects in 21 CFR Part 510 Administrative practice and procedure, Animal drugs...

78 FR 42088 - Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-15

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation AGENCY: Food and Drug Administration..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31...

77 FR 59930 - Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-01

... for comments. SUMMARY: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research... Contacts: Randi Clark, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver...

78 FR 13686 - Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-28

... Prescription Drug and Biological Products Labeling; Availability AGENCY: Food and Drug Administration, HHS... (BPCA) and the Pediatric Research Equity Act (PREA), as amended by the Food and Drug Administration... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...

On the asymptotic improvement of supervised learning by utilizing additional unlabeled samples - Normal mixture density case

NASA Technical Reports Server (NTRS)

Shahshahani, Behzad M.; Landgrebe, David A.

1992-01-01

The effect of additional unlabeled samples in improving the supervised learning process is studied in this paper. Three learning processes. supervised, unsupervised, and combined supervised-unsupervised, are compared by studying the asymptotic behavior of the estimates obtained under each process. Upper and lower bounds on the asymptotic covariance matrices are derived. It is shown that under a normal mixture density assumption for the probability density function of the feature space, the combined supervised-unsupervised learning is always superior to the supervised learning in achieving better estimates. Experimental results are provided to verify the theoretical concepts.

Massively parallel unsupervised single-particle cryo-EM data clustering via statistical manifold learning

PubMed Central

Wu, Jiayi; Ma, Yong-Bei; Congdon, Charles; Brett, Bevin; Chen, Shuobing; Xu, Yaofang; Ouyang, Qi

2017-01-01

Structural heterogeneity in single-particle cryo-electron microscopy (cryo-EM) data represents a major challenge for high-resolution structure determination. Unsupervised classification may serve as the first step in the assessment of structural heterogeneity. However, traditional algorithms for unsupervised classification, such as K-means clustering and maximum likelihood optimization, may classify images into wrong classes with decreasing signal-to-noise-ratio (SNR) in the image data, yet demand increased computational costs. Overcoming these limitations requires further development of clustering algorithms for high-performance cryo-EM data processing. Here we introduce an unsupervised single-particle clustering algorithm derived from a statistical manifold learning framework called generative topographic mapping (GTM). We show that unsupervised GTM clustering improves classification accuracy by about 40% in the absence of input references for data with lower SNRs. Applications to several experimental datasets suggest that our algorithm can detect subtle structural differences among classes via a hierarchical clustering strategy. After code optimization over a high-performance computing (HPC) environment, our software implementation was able to generate thousands of reference-free class averages within hours in a massively parallel fashion, which allows a significant improvement on ab initio 3D reconstruction and assists in the computational purification of homogeneous datasets for high-resolution visualization. PMID:28786986

Massively parallel unsupervised single-particle cryo-EM data clustering via statistical manifold learning.

PubMed

Wu, Jiayi; Ma, Yong-Bei; Congdon, Charles; Brett, Bevin; Chen, Shuobing; Xu, Yaofang; Ouyang, Qi; Mao, Youdong

2017-01-01

Structural heterogeneity in single-particle cryo-electron microscopy (cryo-EM) data represents a major challenge for high-resolution structure determination. Unsupervised classification may serve as the first step in the assessment of structural heterogeneity. However, traditional algorithms for unsupervised classification, such as K-means clustering and maximum likelihood optimization, may classify images into wrong classes with decreasing signal-to-noise-ratio (SNR) in the image data, yet demand increased computational costs. Overcoming these limitations requires further development of clustering algorithms for high-performance cryo-EM data processing. Here we introduce an unsupervised single-particle clustering algorithm derived from a statistical manifold learning framework called generative topographic mapping (GTM). We show that unsupervised GTM clustering improves classification accuracy by about 40% in the absence of input references for data with lower SNRs. Applications to several experimental datasets suggest that our algorithm can detect subtle structural differences among classes via a hierarchical clustering strategy. After code optimization over a high-performance computing (HPC) environment, our software implementation was able to generate thousands of reference-free class averages within hours in a massively parallel fashion, which allows a significant improvement on ab initio 3D reconstruction and assists in the computational purification of homogeneous datasets for high-resolution visualization.

A comparative evaluation of supervised and unsupervised representation learning approaches for anaplastic medulloblastoma differentiation

NASA Astrophysics Data System (ADS)

Cruz-Roa, Angel; Arevalo, John; Basavanhally, Ajay; Madabhushi, Anant; González, Fabio

2015-01-01

Learning data representations directly from the data itself is an approach that has shown great success in different pattern recognition problems, outperforming state-of-the-art feature extraction schemes for different tasks in computer vision, speech recognition and natural language processing. Representation learning applies unsupervised and supervised machine learning methods to large amounts of data to find building-blocks that better represent the information in it. Digitized histopathology images represents a very good testbed for representation learning since it involves large amounts of high complex, visual data. This paper presents a comparative evaluation of different supervised and unsupervised representation learning architectures to specifically address open questions on what type of learning architectures (deep or shallow), type of learning (unsupervised or supervised) is optimal. In this paper we limit ourselves to addressing these questions in the context of distinguishing between anaplastic and non-anaplastic medulloblastomas from routine haematoxylin and eosin stained images. The unsupervised approaches evaluated were sparse autoencoders and topographic reconstruct independent component analysis, and the supervised approach was convolutional neural networks. Experimental results show that shallow architectures with more neurons are better than deeper architectures without taking into account local space invariances and that topographic constraints provide useful invariant features in scale and rotations for efficient tumor differentiation.

Drug misuse in sport: a New Zealand perspective.

PubMed

Curtis, Andrew; Gerrard, David; Burt, Peter; Osborne, Hamish

2015-12-04

Drug misuse in elite sport is a world-wide phenomenon. This article explores the culture of contemporary sport, provides estimates of doping prevalence, discusses dietary supplementation and highlights major factors influencing high-performance athletes and their support personnel. The aim is to stimulate discussion, informed by the World Anti-Doping Code (WADC), which is particularly relevant to doctors caring for athletes. Online databases were searched for relevant peer-reviewed research from 2009 to 2015. Comparative New Zealand data have been included. Estimates of the prevalence of sports doping range from less than 1% to as high as 52%, dependent upon the demographics of the identified cohort. The culture of elite sport, personal stressors, competitive demands, financial reward and the influence of an 'entourage' of support personnel were identified as critical determinants of drug misuse. The culture of elite contemporary sport is seductive to many aspiring young athletes. To combat drug misuse, effective education should embody moral, ethical and clinical dangers, recognising the importance of support at times of increased athlete vulnerability. Inadvertent doping from product contamination is a recognised risk of unsupervised dietary supplementation. Doctors responsible for the care of high-performance athletes must be cognisant of these issues and the provisions of the WADC.

78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

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... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

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2011-12-20

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2011-03-28

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2011-01-06

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2011-08-16

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77 FR 26162 - Amendments to Sterility Test Requirements for Biological Products

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75 FR 79383 - Unapproved Animal Drugs

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2010-12-20

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Classification of highly unbalanced CYP450 data of drugs using cost sensitive machine learning techniques.

PubMed

Eitrich, T; Kless, A; Druska, C; Meyer, W; Grotendorst, J

2007-01-01

In this paper, we study the classifications of unbalanced data sets of drugs. As an example we chose a data set of 2D6 inhibitors of cytochrome P450. The human cytochrome P450 2D6 isoform plays a key role in the metabolism of many drugs in the preclinical drug discovery process. We have collected a data set from annotated public data and calculated physicochemical properties with chemoinformatics methods. On top of this data, we have built classifiers based on machine learning methods. Data sets with different class distributions lead to the effect that conventional machine learning methods are biased toward the larger class. To overcome this problem and to obtain sensitive but also accurate classifiers we combine machine learning and feature selection methods with techniques addressing the problem of unbalanced classification, such as oversampling and threshold moving. We have used our own implementation of a support vector machine algorithm as well as the maximum entropy method. Our feature selection is based on the unsupervised McCabe method. The classification results from our test set are compared structurally with compounds from the training set. We show that the applied algorithms enable the effective high throughput in silico classification of potential drug candidates.

Random Forest Segregation of Drug Responses May Define Regions of Biological Significance

PubMed Central

Bukhari, Qasim; Borsook, David; Rudin, Markus; Becerra, Lino

2016-01-01

The ability to assess brain responses in unsupervised manner based on fMRI measure has remained a challenge. Here we have applied the Random Forest (RF) method to detect differences in the pharmacological MRI (phMRI) response in rats to treatment with an analgesic drug (buprenorphine) as compared to control (saline). Three groups of animals were studied: two groups treated with different doses of the opioid buprenorphine, low (LD), and high dose (HD), and one receiving saline. PhMRI responses were evaluated in 45 brain regions and RF analysis was applied to allocate rats to the individual treatment groups. RF analysis was able to identify drug effects based on differential phMRI responses in the hippocampus, amygdala, nucleus accumbens, superior colliculus, and the lateral and posterior thalamus for drug vs. saline. These structures have high levels of mu opioid receptors. In addition these regions are involved in aversive signaling, which is inhibited by mu opioids. The results demonstrate that buprenorphine mediated phMRI responses comprise characteristic features that allow a supervised differentiation from placebo treated rats as well as the proper allocation to the respective drug dose group using the RF method, a method that has been successfully applied in clinical studies. PMID:27014046

Accuracy of manual entry of drug administration data into an anesthesia information management system.

PubMed

Avidan, Alexander; Dotan, Koren; Weissman, Charles; Cohen, Matan J; Levin, Phillip D

2014-11-01

Data on drug administration are entered manually into anesthesia information management systems (AIMS). This study examined whether these data are accurate regarding drug name, dose administered, and time of administration, and whether the stage of anesthesia influences data accuracy. Real-time observational data on drug administration during elective operations were compared with computerized information on drug administration entered by anesthesiologists. A trained observer (K.D.) performed the observations. Data were collected during 57 operations which included 596 separate occasions of drug administration by 22 anesthesiologists. No AIMS records were found for 90 (15.1%) occasions of drug administration (omissions), while there were 11 (1.8%) AIMS records where drug administration was not observed. The AIMS and observer data matched for drug name on 495 of 596 (83.1%) occasions, for dose on 439 of 495 (92.5%) occasions, and for time on 476 of 495 (96.2%) occasions. Amongst the 90 omitted records, 34 (37.8%) were for vasoactive drugs with 24 (27.7%) for small doses of hypnotics. Omissions occurred mostly during maintenance: 50 of 153 (24.6%), followed by induction: 30 of 325 (9.2%) and emergence: 10 of 57 (17.5%) (P < 0.001). Time and dose inaccuracies occurred mainly during induction, followed by maintenance and emergence; time inaccuracies were 7/325 (8.3%), 10/203 (4.9%), and 0/57 (0%), respectively (P = 0.07), and dose inaccuracies were 15/325 (4.6%), 3/203 (1.5%), and 1/57 (1.7%), respectively (P = 0.11). The range of accuracy varies when anesthesiologists manually enter drug administration data into an AIMS. Charting omissions represent the largest cause of inaccuracy, principally by omissions of records for vasopressors and small doses of hypnotic drugs. Manually entered drug administration data are not without errors. Accuracy of entering drug administration data remains the responsibility of the anesthesiologist.

Dyslexic Participants Show Intact Spontaneous Categorization Processes

ERIC Educational Resources Information Center

Nikolopoulos, Dimitris S.; Pothos, Emmanuel M.

2009-01-01

We examine the performance of dyslexic participants on an unsupervised categorization task against that of matched non-dyslexic control participants. Unsupervised categorization is a cognitive process critical for conceptual development. Existing research in dyslexia has emphasized perceptual tasks and supervised categorization tasks (for which…

76 FR 79701 - Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97...

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2011-12-22

...: Florine Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0411... Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction...

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2013-03-13

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2011-10-19

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2013-11-15

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2013-03-13

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78 FR 44251 - Regulatory Agenda

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2013-07-23

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21 CFR 1316.09 - Application for administrative inspection warrant.

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2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Application for administrative inspection warrant. 1316.09 Section 1316.09 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.09 Application for...

Housing and sexual health among street-involved youth.

PubMed

Kumar, Maya M; Nisenbaum, Rosane; Barozzino, Tony; Sgro, Michael; Bonifacio, Herbert J; Maguire, Jonathon L

2015-10-01

Street-involved youth (SIY) carry a disproportionate burden of sexually transmitted diseases (STD). Studies among adults suggest that improving housing stability may be an effective primary prevention strategy for improving sexual health. Housing options available to SIY offer varying degrees of stability and adult supervision. This study investigated whether housing options offering more stability and adult supervision are associated with fewer STD and related risk behaviors among SIY. A cross-sectional study was performed using public health survey and laboratory data collected from Toronto SIY in 2010. Three exposure categories were defined a priori based on housing situation: (1) stable and supervised housing, (2) stable and unsupervised housing, and (3) unstable and unsupervised housing. Multivariate logistic regression was used to test the association between housing category and current or recent STD. Secondary analyses were performed using the following secondary outcomes: blood-borne infection, recent binge-drinking, and recent high-risk sexual behavior. The final analysis included 184 SIY. Of these, 28.8 % had a current or recent STD. Housing situation was stable and supervised for 12.5 %, stable and unsupervised for 46.2 %, and unstable and unsupervised for 41.3 %. Compared to stable and supervised housing, there was no significant association between current or recent STD among stable and unsupervised housing or unstable and unsupervised housing. There was no significant association between housing category and risk of blood-borne infection, binge-drinking, or high-risk sexual behavior. Although we did not demonstrate a significant association between stable and supervised housing and lower STD risk, our incorporation of both housing stability and adult supervision into a priori defined exposure groups may inform future studies of housing-related prevention strategies among SIY. Multi-modal interventions beyond housing alone may also be required to prevent sexual morbidity among these vulnerable youth.

Out-of-School Time and Adolescent Substance Use.

PubMed

Lee, Kenneth T H; Vandell, Deborah Lowe

2015-11-01

High levels of adolescent substance use are linked to lower academic achievement, reduced schooling, and delinquency. We assess four types of out-of-school time (OST) contexts--unsupervised time with peers, sports, organized activities, and paid employment--in relation to tobacco, alcohol, and marijuana use at the end of high school. Other research has examined these OST contexts in isolation, limiting efforts to disentangle potentially confounded relations. Longitudinal data from the National Institute of Child Health and Human Development Study of Early Child Care and Youth Development (N = 766) examined associations between different OST contexts during high school and substance use at the end of high school. Unsupervised time with peers increased the odds of tobacco, alcohol, and marijuana use, whereas sports increased the odds of alcohol use and decreased the odds of marijuana use. Paid employment increased the odds of tobacco and alcohol use. Unsupervised time with peers predicted increased amounts of tobacco, alcohol, and marijuana use, whereas sports predicted decreased amounts of tobacco and marijuana use and increased amounts of alcohol use at the end of high school. Although unsupervised time with peers, sports, and paid employment were differentially linked to the odds of substance use, only unsupervised time with peers and sports were significantly associated with the amounts of tobacco, alcohol, and marijuana use at the end of high school. These findings underscore the value of considering OST contexts in relation to strategies to promote adolescent health. Reducing unsupervised time with peers and increasing sports participation may have positive impacts on reducing substance use. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Learning from label proportions in brain-computer interfaces: Online unsupervised learning with guarantees.

PubMed

Hübner, David; Verhoeven, Thibault; Schmid, Konstantin; Müller, Klaus-Robert; Tangermann, Michael; Kindermans, Pieter-Jan

2017-01-01

Using traditional approaches, a brain-computer interface (BCI) requires the collection of calibration data for new subjects prior to online use. Calibration time can be reduced or eliminated e.g., by subject-to-subject transfer of a pre-trained classifier or unsupervised adaptive classification methods which learn from scratch and adapt over time. While such heuristics work well in practice, none of them can provide theoretical guarantees. Our objective is to modify an event-related potential (ERP) paradigm to work in unison with the machine learning decoder, and thus to achieve a reliable unsupervised calibrationless decoding with a guarantee to recover the true class means. We introduce learning from label proportions (LLP) to the BCI community as a new unsupervised, and easy-to-implement classification approach for ERP-based BCIs. The LLP estimates the mean target and non-target responses based on known proportions of these two classes in different groups of the data. We present a visual ERP speller to meet the requirements of LLP. For evaluation, we ran simulations on artificially created data sets and conducted an online BCI study with 13 subjects performing a copy-spelling task. Theoretical considerations show that LLP is guaranteed to minimize the loss function similar to a corresponding supervised classifier. LLP performed well in simulations and in the online application, where 84.5% of characters were spelled correctly on average without prior calibration. The continuously adapting LLP classifier is the first unsupervised decoder for ERP BCIs guaranteed to find the optimal decoder. This makes it an ideal solution to avoid tedious calibration sessions. Additionally, LLP works on complementary principles compared to existing unsupervised methods, opening the door for their further enhancement when combined with LLP.

Learning from label proportions in brain-computer interfaces: Online unsupervised learning with guarantees

PubMed Central

Verhoeven, Thibault; Schmid, Konstantin; Müller, Klaus-Robert; Tangermann, Michael; Kindermans, Pieter-Jan

2017-01-01

Objective Using traditional approaches, a brain-computer interface (BCI) requires the collection of calibration data for new subjects prior to online use. Calibration time can be reduced or eliminated e.g., by subject-to-subject transfer of a pre-trained classifier or unsupervised adaptive classification methods which learn from scratch and adapt over time. While such heuristics work well in practice, none of them can provide theoretical guarantees. Our objective is to modify an event-related potential (ERP) paradigm to work in unison with the machine learning decoder, and thus to achieve a reliable unsupervised calibrationless decoding with a guarantee to recover the true class means. Method We introduce learning from label proportions (LLP) to the BCI community as a new unsupervised, and easy-to-implement classification approach for ERP-based BCIs. The LLP estimates the mean target and non-target responses based on known proportions of these two classes in different groups of the data. We present a visual ERP speller to meet the requirements of LLP. For evaluation, we ran simulations on artificially created data sets and conducted an online BCI study with 13 subjects performing a copy-spelling task. Results Theoretical considerations show that LLP is guaranteed to minimize the loss function similar to a corresponding supervised classifier. LLP performed well in simulations and in the online application, where 84.5% of characters were spelled correctly on average without prior calibration. Significance The continuously adapting LLP classifier is the first unsupervised decoder for ERP BCIs guaranteed to find the optimal decoder. This makes it an ideal solution to avoid tedious calibration sessions. Additionally, LLP works on complementary principles compared to existing unsupervised methods, opening the door for their further enhancement when combined with LLP. PMID:28407016

Parental Monitoring, Negotiated Unsupervised Time, and Parental Trust: The Role of Perceived Parenting Practices in Adolescent Health Risk Behaviors

PubMed Central

BORAWSKI, ELAINE A.; IEVERS-LANDIS, CAROLYN E.; LOVEGREEN, LOREN D.; TRAPL, ERIKA S.

2010-01-01

Purpose To compare two different parenting practices (parental monitoring and negotiated unsupervised time) and perceived parental trust in the reporting of health risk behaviors among adolescents. Methods Data were derived from 692 adolescents in 9th and 10th grades (X̄ = 15.7 years) enrolled in health education classes in six urban high schools. Students completed a self-administered paper-based survey that assessed adolescents’ perceptions of the degree to which their parents monitor their whereabouts, are permitted to negotiate unsupervised time with their friends and trust them to make decisions. Using gender-specific multivariate logistic regression analyses, we examined the relative importance of parental monitoring, negotiated unsupervised time with peers, and parental trust in predicting reported sexual activity, sex-related protective actions (e.g., condom use, carrying protection) and substance use (alcohol, tobacco, and marijuana). Results For males and females, increased negotiated unsupervised time was strongly associated with increased risk behavior (e.g., sexual activity, alcohol and marijuana use) but also sex-related protective actions. In males, high parental monitoring was associated with less alcohol use and consistent condom use. Parental monitoring had no affect on female behavior. Perceived parental trust served as a protective factor against sexual activity, tobacco, and marijuana use in females, and alcohol use in males. Conclusions Although monitoring is an important practice for parents of older adolescents, managing their behavior through negotiation of unsupervised time may have mixed results leading to increased experimentation with sexuality and substances, but perhaps in a more responsible way. Trust established between an adolescent female and her parents continues to be a strong deterrent for risky behaviors but appears to have little effect on behaviors of adolescent males. PMID:12890596

76 FR 72953 - Science Board to the Food and Drug Administration; Notice of Meeting

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76 FR 30727 - Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance

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2011-05-26

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2013-05-14

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2013-01-24

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

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2012-03-09

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2011-12-13

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... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0576] Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product Surveillance Discussions (U13) RFA- FD-09-012; Request for Supplemental Application AGENCY: Food and Drug Administration...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0469] Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

77 FR 33746 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0110...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr...

76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0800... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD...

77 FR 40069 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0563... Labeled for Human Use; Enforcement Action Dates AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing its intention to take enforcement...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0147] Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During the Review of Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0530... Program and Meetings With FDA Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft...

78 FR 5713 - New Animal Drugs; Cefpodoxime; Meloxicam

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and 522 [Docket No. FDA-2012-N-0002] New Animal Drugs; Cefpodoxime; Meloxicam AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is...

76 FR 79198 - Generic Drug User Fee; Public Meeting; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared...

77 FR 44177 - Antimicrobial Animal Drug Sales and Distribution Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 [Docket No. FDA-2012-N-0447] Antimicrobial Animal Drug Sales and Distribution Reporting AGENCY: Food and Drug Administration, HHS. ACTION: Advance notice of proposed rulemaking. SUMMARY: The Food and Drug Administration...

21 CFR 1316.07 - Requirement for administrative inspection warrant; exceptions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Requirement for administrative inspection warrant; exceptions. 1316.07 Section 1316.07 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.07 Requirement for...

78 FR 69133 - Drug Enforcement Administration

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-18

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances..., California 94085, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Schedule...

Unsupervised Cryo-EM Data Clustering through Adaptively Constrained K-Means Algorithm

PubMed Central

Xu, Yaofang; Wu, Jiayi; Yin, Chang-Cheng; Mao, Youdong

2016-01-01

In single-particle cryo-electron microscopy (cryo-EM), K-means clustering algorithm is widely used in unsupervised 2D classification of projection images of biological macromolecules. 3D ab initio reconstruction requires accurate unsupervised classification in order to separate molecular projections of distinct orientations. Due to background noise in single-particle images and uncertainty of molecular orientations, traditional K-means clustering algorithm may classify images into wrong classes and produce classes with a large variation in membership. Overcoming these limitations requires further development on clustering algorithms for cryo-EM data analysis. We propose a novel unsupervised data clustering method building upon the traditional K-means algorithm. By introducing an adaptive constraint term in the objective function, our algorithm not only avoids a large variation in class sizes but also produces more accurate data clustering. Applications of this approach to both simulated and experimental cryo-EM data demonstrate that our algorithm is a significantly improved alterative to the traditional K-means algorithm in single-particle cryo-EM analysis. PMID:27959895

Unsupervised Cryo-EM Data Clustering through Adaptively Constrained K-Means Algorithm.

PubMed

Xu, Yaofang; Wu, Jiayi; Yin, Chang-Cheng; Mao, Youdong

2016-01-01

In single-particle cryo-electron microscopy (cryo-EM), K-means clustering algorithm is widely used in unsupervised 2D classification of projection images of biological macromolecules. 3D ab initio reconstruction requires accurate unsupervised classification in order to separate molecular projections of distinct orientations. Due to background noise in single-particle images and uncertainty of molecular orientations, traditional K-means clustering algorithm may classify images into wrong classes and produce classes with a large variation in membership. Overcoming these limitations requires further development on clustering algorithms for cryo-EM data analysis. We propose a novel unsupervised data clustering method building upon the traditional K-means algorithm. By introducing an adaptive constraint term in the objective function, our algorithm not only avoids a large variation in class sizes but also produces more accurate data clustering. Applications of this approach to both simulated and experimental cryo-EM data demonstrate that our algorithm is a significantly improved alterative to the traditional K-means algorithm in single-particle cryo-EM analysis.

75 FR 34464 - Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com; Correction of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

... 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... date of the memorandum of understanding (MOU) between FDA and Drugs.Com that published in the Federal...

75 FR 37818 - Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

... Moser or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, Office of... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...

76 FR 76738 - Generic Drug User Fee; Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. The Food and Drug Administration (FDA) is announcing a public meeting to...

77 FR 15961 - Oral Dosage Form New Animal Drugs; Phenylpropanolamine

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Phenylpropanolamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal...

77 FR 55414 - New Animal Drugs; Enrofloxacin; Tylvalosin

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 522, and 556 [Docket No. FDA-2012-N-0002] New Animal Drugs; Enrofloxacin; Tylvalosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal...

78 FR 17595 - New Animal Drugs; Changes of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 529, and 558 [Docket No. FDA-2013-N-0002] New Animal Drugs; Changes of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is...

75 FR 71450 - Oncologic Drugs Advisory Committee; Amendment of Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of a...

77 FR 37911 - Oncologic Drugs Advisory Committee; Amendment of Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the...

78 FR 21058 - New Animal Drugs; Change of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 526, 529, and 558 [Docket No. FDA-2013-N-0002] New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is...

78 FR 70062 - Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0002] Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of...

21 CFR 21.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Definitions. 21.3 Section 21.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY General... products regulated by the Food and Drug Administration or with which the Food and Drug Administration has...

21 CFR 21.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Definitions. 21.3 Section 21.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY General... products regulated by the Food and Drug Administration or with which the Food and Drug Administration has...

21 CFR 21.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Definitions. 21.3 Section 21.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY General... products regulated by the Food and Drug Administration or with which the Food and Drug Administration has...

21 CFR 21.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Definitions. 21.3 Section 21.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY General... products regulated by the Food and Drug Administration or with which the Food and Drug Administration has...

77 FR 29216 - New Animal Drugs; Ceftiofur Sodium; Lincomycin Powder; Naracin; Tylosin

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522...; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug...: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl...

76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...

75 FR 54016 - New Animal Drugs; Change of Sponsor's Name and Address

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-03

.... FDA-2010-N-0002] New Animal Drugs; Change of Sponsor's Name and Address AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal... in 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and...

76 FR 40612 - New Animal Drugs; Change of Sponsor's Name and Address

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-11

.... FDA-2011-N-0003] New Animal Drugs; Change of Sponsor's Name and Address AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal... Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements...

76 FR 19375 - Safety and Efficacy of Hypnotic Drugs; Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Safety and Efficacy of Hypnotic Drugs; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. The Food and Drug Administration (FDA) is announcing a public meeting to...

77 FR 60442 - Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0981] Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

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...

77 FR 41415 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... INFORMATION CONTACT: Astrid Lopez-Goldberg, Center for Drug Evaluation and Research, Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0563] Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and...

78 FR 43209 - Narcolepsy Public Meeting on Patient-Focused Drug Development

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0815] Narcolepsy Public Meeting on Patient-Focused Drug Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA...

78 FR 58313 - Fibromyalgia Public Meeting on Patient-Focused Drug Development

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1041] Fibromyalgia Public Meeting on Patient-Focused Drug Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA...

78 FR 64956 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...

75 FR 22146 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Advisory...

76 FR 70462 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Advisory...

21 CFR 1316.12 - Refusal to allow inspection with an administrative warrant.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Refusal to allow inspection with an administrative warrant. 1316.12 Section 1316.12 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.12 Refusal to allow...

21 CFR 21.31 - Records stored by the National Archives and Records Administration.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Records stored by the National Archives and Records Administration. 21.31 Section 21.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... § 21.31 Records stored by the National Archives and Records Administration. (a) Food and Drug...

75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-22

...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...

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...

77 FR 70166 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-23

...; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is establishing a public docket for information pertaining to FDA's... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1090...

75 FR 17418 - Memorandum of Understanding Between the Food and Drug Administration, United States Department of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004] Memorandum of Understanding Between the Food and Drug Administration, United States Department of Health and... understanding (MOU) between the Food and Drug Administration, U.S. Department of Health and Human Services and...

Unsupervised iterative detection of land mines in highly cluttered environments.

PubMed

Batman, Sinan; Goutsias, John

2003-01-01

An unsupervised iterative scheme is proposed for land mine detection in heavily cluttered scenes. This scheme is based on iterating hybrid multispectral filters that consist of a decorrelating linear transform coupled with a nonlinear morphological detector. Detections extracted from the first pass are used to improve results in subsequent iterations. The procedure stops after a predetermined number of iterations. The proposed scheme addresses several weaknesses associated with previous adaptations of morphological approaches to land mine detection. Improvement in detection performance, robustness with respect to clutter inhomogeneities, a completely unsupervised operation, and computational efficiency are the main highlights of the method. Experimental results reveal excellent performance.

Unsupervised progressive elastic band exercises for frail geriatric inpatients objectively monitored by new exercise-integrated technology-a feasibility trial with an embedded qualitative study.

PubMed

Rathleff, C R; Bandholm, T; Spaich, E G; Jorgensen, M; Andreasen, J

2017-01-01

Frailty is a serious condition frequently present in geriatric inpatients that potentially causes serious adverse events. Strength training is acknowledged as a means of preventing or delaying frailty and loss of function in these patients. However, limited hospital resources challenge the amount of supervised training, and unsupervised training could possibly supplement supervised training thereby increasing the total exercise dose during admission. A new valid and reliable technology, the BandCizer, objectively measures the exact training dosage performed. The purpose was to investigate feasibility and acceptability of an unsupervised progressive strength training intervention monitored by BandCizer for frail geriatric inpatients. This feasibility trial included 15 frail inpatients at a geriatric ward. At hospitalization, the patients were prescribed two elastic band exercises to be performed unsupervised once daily. A BandCizer Datalogger enabling measurement of the number of sets, repetitions, and time-under-tension was attached to the elastic band. The patients were instructed in performing strength training: 3 sets of 10 repetitions (10-12 repetition maximum (RM)) with a separation of 2-min pauses and a time-under-tension of 8 s. The feasibility criterion for the unsupervised progressive exercises was that 33% of the recommended number of sets would be performed by at least 30% of patients. In addition, patients and staff were interviewed about their experiences with the intervention. Four (27%) out of 15 patients completed 33% of the recommended number of sets. For the total sample, the average percent of performed sets was 23% and for those who actually trained ( n  = 12) 26%. Patients and staff expressed a general positive attitude towards the unsupervised training as an addition to the supervised training sessions. However, barriers were also described-especially constant interruptions. Based on the predefined criterion for feasibility, the unsupervised training was not feasible, although the criterion was almost met. The patients and staff mainly expressed positive attitudes towards the unsupervised training. As even a small training dosage has been shown to improve the physical performance of geriatric inpatients, the proposed intervention might be relevant if the interruptions are decreased in future large-scale trials and if the adherence is increased. ClinicalTrials.gov: NCT02702557, February 29, 2016. Data Protection Agency: 2016-42, February 25, 2016. Ethics Committee: No registration needed, December 8, 2015 (e-mail correspondence).

Manifold Learning in MR spectroscopy using nonlinear dimensionality reduction and unsupervised clustering.

PubMed

Yang, Guang; Raschke, Felix; Barrick, Thomas R; Howe, Franklyn A

2015-09-01

To investigate whether nonlinear dimensionality reduction improves unsupervised classification of (1) H MRS brain tumor data compared with a linear method. In vivo single-voxel (1) H magnetic resonance spectroscopy (55 patients) and (1) H magnetic resonance spectroscopy imaging (MRSI) (29 patients) data were acquired from histopathologically diagnosed gliomas. Data reduction using Laplacian eigenmaps (LE) or independent component analysis (ICA) was followed by k-means clustering or agglomerative hierarchical clustering (AHC) for unsupervised learning to assess tumor grade and for tissue type segmentation of MRSI data. An accuracy of 93% in classification of glioma grade II and grade IV, with 100% accuracy in distinguishing tumor and normal spectra, was obtained by LE with unsupervised clustering, but not with the combination of k-means and ICA. With (1) H MRSI data, LE provided a more linear distribution of data for cluster analysis and better cluster stability than ICA. LE combined with k-means or AHC provided 91% accuracy for classifying tumor grade and 100% accuracy for identifying normal tissue voxels. Color-coded visualization of normal brain, tumor core, and infiltration regions was achieved with LE combined with AHC. The LE method is promising for unsupervised clustering to separate brain and tumor tissue with automated color-coding for visualization of (1) H MRSI data after cluster analysis. © 2014 Wiley Periodicals, Inc.

A comparative analysis of pixel- and object-based detection of landslides from very high-resolution images

NASA Astrophysics Data System (ADS)

Keyport, Ren N.; Oommen, Thomas; Martha, Tapas R.; Sajinkumar, K. S.; Gierke, John S.

2018-02-01

A comparative analysis of landslides detected by pixel-based and object-oriented analysis (OOA) methods was performed using very high-resolution (VHR) remotely sensed aerial images for the San Juan La Laguna, Guatemala, which witnessed widespread devastation during the 2005 Hurricane Stan. A 3-band orthophoto of 0.5 m spatial resolution together with a 115 field-based landslide inventory were used for the analysis. A binary reference was assigned with a zero value for landslide and unity for non-landslide pixels. The pixel-based analysis was performed using unsupervised classification, which resulted in 11 different trial classes. Detection of landslides using OOA includes 2-step K-means clustering to eliminate regions based on brightness; elimination of false positives using object properties such as rectangular fit, compactness, length/width ratio, mean difference of objects, and slope angle. Both overall accuracy and F-score for OOA methods outperformed pixel-based unsupervised classification methods in both landslide and non-landslide classes. The overall accuracy for OOA and pixel-based unsupervised classification was 96.5% and 94.3%, respectively, whereas the best F-score for landslide identification for OOA and pixel-based unsupervised methods: were 84.3% and 77.9%, respectively.Results indicate that the OOA is able to identify the majority of landslides with a few false positive when compared to pixel-based unsupervised classification.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD... Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852...: Colleen L. Locicero, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...

76 FR 32863 - Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-07

..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51...-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51...

76 FR 48714 - New Animal Drugs; Change of Sponsor; Moxidectin

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 522, and 524 [Docket No. FDA-2011-N-0003] New Animal Drugs; Change of Sponsor; Moxidectin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal...

78 FR 70496 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2013-N-0002] Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is...

78 FR 70566 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0002] Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of a new...

77 FR 9528 - Animal Drugs, Feeds, and Related Products; N-Methyl-2-Pyrrolidone; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 500 [Docket No...: Food and Drug Administration, HHS. ACTION: Final rule; correcting amendment. SUMMARY: The Food and Drug...: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl...

75 FR 59732 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Gastrointestinal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting...

78 FR 42381 - Administrative Detention of Drugs Intended for Human or Animal Use

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-15

... drug supply chain. Specifically, FDA will be able to administratively detain drugs encountered during... integrity of the drug supply chain. Specifically, administrative detention is intended to protect the public... better protect the integrity of the drug supply chain. One of those new authorities is section 709, which...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

76 FR 11794 - Drugs for Human Use; Unapproved and Misbranded Oral Drugs Labeled for Prescription Use and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0100... Relief of Symptoms of Cold, Cough, or Allergy; Enforcement Action Dates AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing its intention...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0529...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... framework for interactions between the Center for Drug Evaluation and Research (CDER) and DDT sponsors to...

78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0800... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and...

21 CFR 874.5220 - Ear, nose, and throat drug administration device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

21 CFR 874.5220 - Ear, nose, and throat drug administration device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

21 CFR 874.5220 - Ear, nose, and throat drug administration device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

21 CFR 874.5220 - Ear, nose, and throat drug administration device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

21 CFR 874.5220 - Ear, nose, and throat drug administration device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

78 FR 44572 - Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-24

..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0836...

75 FR 1060 - Draft Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-08

... Medically Necessary Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., WO Bldg. 51, rm. 3359...

77 FR 12852 - Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-02

... Evaluation and Research- Regulated Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm... Drug Evaluation and Research (HFD-003), Food and Drug Administration, Bldg. 51, Rm. 4154, 10903 New...

21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record... of each year a notice concerning each Privacy Act Record System as defined in § 21.3(c) that is not...

21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record... of each year a notice concerning each Privacy Act Record System as defined in § 21.3(c) that is not...

21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record... of each year a notice concerning each Privacy Act Record System as defined in § 21.3(c) that is not...

21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record... of each year a notice concerning each Privacy Act Record System as defined in § 21.3(c) that is not...

77 FR 60440 - Clinical Investigator Training Course

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Clinical Investigator Training Course AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research/Office of Medical...

21 CFR 1316.11 - Execution of warrants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Execution of warrants. 1316.11 Section 1316.11 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.11 Execution of warrants. An administrative...

76 FR 8775 - Agency Information Collection Activities: Proposed Collection; Comments Requested: Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-15

..., Human Resources Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152... Administrator, Human Resources Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield... Administration (DEA) will be submitting the following information collection request to the Office of Management...

Feature Extraction Using an Unsupervised Neural Network

DTIC Science & Technology

1991-05-03

with this neural netowrk is given and its connection to exploratory projection pursuit methods is established. DD I 2 P JA d 73 EDITIONj Of I NOV 6s...IS OBSOLETE $IN 0102- LF- 014- 6601 SECURITY CLASSIFICATION OF THIS PAGE (When Daoes Enlered) Feature Extraction using an Unsupervised Neural Network

An Unsupervised Method for Uncovering Morphological Chains (Open Access, Publisher’s Version)

DTIC Science & Technology

2015-03-08

Consortium. Marco Baroni, Johannes Matiasek, and Harald Trost. 2002. Unsupervised discovery of morphologically re- lated words based on orthographic and...Better word representations with re- cursive neural networks for morphology. In CoNLL, Sofia, Bulgaria. Mohamed Maamouri, Ann Bies, Hubert Jin, and Tim

21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Records available in Food and Drug Administration Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.120 Records available in Food and Drug...

21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Records available in Food and Drug Administration Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.120 Records available in Food and Drug...

21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Records available in Food and Drug Administration Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.120 Records available in Food and Drug...

21 CFR 1316.08 - Consent to inspection.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Consent to inspection. 1316.08 Section 1316.08 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.08 Consent to inspection. (a) An administrative...

21 CFR 20.3 - Certification and authentication of Food and Drug Administration records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Certification and authentication of Food and Drug... authentication of Food and Drug Administration records. (a) Upon request, the Food and Drug Administration will... or for authentication of records shall be sent in writing to the Freedom of Information Staff (HFI-35...

78 FR 12762 - Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...; Notice of Meeting. AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will...

21 CFR 20.110 - Data and information about Food and Drug Administration employees.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Data and information about Food and Drug Administration employees. 20.110 Section 20.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.110...

21 CFR 20.108 - Agreements between the Food and Drug Administration and other departments, agencies, and...

Code of Federal Regulations, 2010 CFR

2010-04-01

... Specific Categories of Records § 20.108 Agreements between the Food and Drug Administration and other... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Agreements between the Food and Drug Administration and other departments, agencies, and organizations. 20.108 Section 20.108 Food and Drugs FOOD AND...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0429] Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products as Drugs... Action'' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act...

76 FR 45814 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0547] Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the rates and...

Role of mass drug administration in elimination of Plasmodium falciparum malaria: a consensus modelling study.

PubMed

Brady, Oliver J; Slater, Hannah C; Pemberton-Ross, Peter; Wenger, Edward; Maude, Richard J; Ghani, Azra C; Penny, Melissa A; Gerardin, Jaline; White, Lisa J; Chitnis, Nakul; Aguas, Ricardo; Hay, Simon I; Smith, David L; Stuckey, Erin M; Okiro, Emelda A; Smith, Thomas A; Okell, Lucy C

2017-07-01

Mass drug administration for elimination of Plasmodium falciparum malaria is recommended by WHO in some settings. We used consensus modelling to understand how to optimise the effects of mass drug administration in areas with low malaria transmission. We collaborated with researchers doing field trials to establish a standard intervention scenario and standard transmission setting, and we input these parameters into four previously published models. We then varied the number of rounds of mass drug administration, coverage, duration, timing, importation of infection, and pre-administration transmission levels. The outcome of interest was the percentage reduction in annual mean prevalence of P falciparum parasite rate as measured by PCR in the third year after the final round of mass drug administration. The models predicted differing magnitude of the effects of mass drug administration, but consensus answers were reached for several factors. Mass drug administration was predicted to reduce transmission over a longer timescale than accounted for by the prophylactic effect alone. Percentage reduction in transmission was predicted to be higher and last longer at lower baseline transmission levels. Reduction in transmission resulting from mass drug administration was predicted to be temporary, and in the absence of scale-up of other interventions, such as vector control, transmission would return to pre-administration levels. The proportion of the population treated in a year was a key determinant of simulated effectiveness, irrespective of whether people are treated through high coverage in a single round or new individuals are reached by implementation of several rounds. Mass drug administration was predicted to be more effective if continued over 2 years rather than 1 year, and if done at the time of year when transmission is lowest. Mass drug administration has the potential to reduce transmission for a limited time, but is not an effective replacement for existing vector control. Unless elimination is achieved, mass drug administration has to be repeated regularly for sustained effect. Bill & Melinda Gates Foundation. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

77 FR 76049 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-26

..., Office of Planning & Informatics, Center for Drug Evaluation and Research, Food and Drug Administration... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0643...: Food and Drug Administration, HHS. ACTION: Notice; correction. [[Page 76050

78 FR 14304 - Adrian Vela: Debarment Order

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-0777] Adrian Vela: Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the...

77 FR 39245 - Sami Arshak Yanikian: Debarment Order

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0063] Sami Arshak Yanikian: Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and...

21 CFR 1316.13 - Frequency of administrative inspections.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Frequency of administrative inspections. 1316.13 Section 1316.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE... as circumstances may require, based in part on the registrant's history of compliance with the...

21 CFR 1316.13 - Frequency of administrative inspections.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Frequency of administrative inspections. 1316.13 Section 1316.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE... as circumstances may require, based in part on the registrant's history of compliance with the...

21 CFR 1316.13 - Frequency of administrative inspections.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Frequency of administrative inspections. 1316.13 Section 1316.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE... as circumstances may require, based in part on the registrant's history of compliance with the...

21 CFR 1316.13 - Frequency of administrative inspections.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Frequency of administrative inspections. 1316.13 Section 1316.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE... as circumstances may require, based in part on the registrant's history of compliance with the...

21 CFR 20.101 - Administrative enforcement records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Administrative enforcement records. 20.101 Section 20.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.101 Administrative enforcement...

76 FR 65371 - Schedules of Controlled Substances: Temporary Placement of Three Synthetic Cathinones Into...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-21

... DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-357...: Drug Enforcement Administration, Department of Justice. ACTION: Final Order. SUMMARY: The Administrator of the Drug Enforcement Administration (DEA) is issuing this final order to temporarily schedule...

76 FR 55616 - Schedules of Controlled Substances: Temporary Placement of Three Synthetic Cathinones Into...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-08

... DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-357...: Drug Enforcement Administration, Department of Justice. ACTION: Notice of Intent. SUMMARY: The Administrator of the Drug Enforcement Administration (DEA) is issuing this notice of intent to temporarily...

21 CFR 1316.13 - Frequency of administrative inspections.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Frequency of administrative inspections. 1316.13 Section 1316.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE... as circumstances may require, based in part on the registrant's history of compliance with the...

21 CFR 868.5165 - Nitric oxide administration apparatus.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nitric oxide administration apparatus. 868.5165 Section 868.5165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5165 Nitric oxide administration...

21 CFR 868.5165 - Nitric oxide administration apparatus.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nitric oxide administration apparatus. 868.5165 Section 868.5165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5165 Nitric oxide administration...

Multimodal system designed to reduce errors in recording and administration of drugs in anaesthesia: prospective randomised clinical evaluation.

PubMed

Merry, Alan F; Webster, Craig S; Hannam, Jacqueline; Mitchell, Simon J; Henderson, Robert; Reid, Papaarangi; Edwards, Kylie-Ellen; Jardim, Anisoara; Pak, Nick; Cooper, Jeremy; Hopley, Lara; Frampton, Chris; Short, Timothy G

2011-09-22

To clinically evaluate a new patented multimodal system (SAFERSleep) designed to reduce errors in the recording and administration of drugs in anaesthesia. Prospective randomised open label clinical trial. Five designated operating theatres in a major tertiary referral hospital. Eighty nine consenting anaesthetists managing 1075 cases in which there were 10,764 drug administrations. Use of the new system (which includes customised drug trays and purpose designed drug trolley drawers to promote a well organised anaesthetic workspace and aseptic technique; pre-filled syringes for commonly used anaesthetic drugs; large legible colour coded drug labels; a barcode reader linked to a computer, speakers, and touch screen to provide automatic auditory and visual verification of selected drugs immediately before each administration; automatic compilation of an anaesthetic record; an on-screen and audible warning if an antibiotic has not been administered within 15 minutes of the start of anaesthesia; and certain procedural rules-notably, scanning the label before each drug administration) versus conventional practice in drug administration with a manually compiled anaesthetic record. Primary: composite of errors in the recording and administration of intravenous drugs detected by direct observation and by detailed reconciliation of the contents of used drug vials against recorded administrations; and lapses in responding to an intermittent visual stimulus (vigilance latency task). Secondary: outcomes in patients; analyses of anaesthetists' tasks and assessments of workload; evaluation of the legibility of anaesthetic records; evaluation of compliance with the procedural rules of the new system; and questionnaire based ratings of the respective systems by participants. The overall mean rate of drug errors per 100 administrations was 9.1 (95% confidence interval 6.9 to 11.4) with the new system (one in 11 administrations) and 11.6 (9.3 to 13.9) with conventional methods (one in nine administrations) (P = 0.045 for difference). Most were recording errors, and, though fewer drug administration errors occurred with the new system, the comparison with conventional methods did not reach significance. Rates of errors in drug administration were lower when anaesthetists consistently applied two key principles of the new system (scanning the drug barcode before administering each drug and keeping the voice prompt active) than when they did not: mean 6.0 (3.1 to 8.8) errors per 100 administrations v 9.7 (8.4 to 11.1) respectively (P = 0.004). Lapses in the vigilance latency task occurred in 12% (58/471) of cases with the new system and 9% (40/473) with conventional methods (P = 0.052). The records generated by the new system were more legible, and anaesthetists preferred the new system, particularly in relation to long, complex, and emergency cases. There were no differences between new and conventional systems in respect of outcomes in patients or anaesthetists' workload. The new system was associated with a reduction in errors in the recording and administration of drugs in anaesthesia, attributable mainly to a reduction in recording errors. Automatic compilation of the anaesthetic record increased legibility but also increased lapses in a vigilance latency task and decreased time spent watching monitors. Trial registration Australian New Zealand Clinical Trials Registry No 12608000068369.

21 CFR 201.129 - Drugs; exemption for radioactive drugs for research use.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs; exemption for radioactive drugs for research use. 201.129 Section 201.129 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Drugs; exemption for radioactive drugs for research use. A radioactive drug intended for administration...

Evaluation of drug administration errors in a teaching hospital

PubMed Central

2012-01-01

Background Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Methods Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds). A pharmacist accompanied nurses and witnessed the preparation and administration of drugs to all patients during the three drug rounds on each of six days per ward. Main outcomes were number, type and clinical importance of errors and associated risk factors. Drug administration error rate was calculated with and without wrong time errors. Relationship between the occurrence of errors and potential risk factors were investigated using logistic regression models with random effects. Results Twenty-eight nurses caring for 108 patients were observed. Among 1501 opportunities for error, 415 administrations (430 errors) with one or more errors were detected (27.6%). There were 312 wrong time errors, ten simultaneously with another type of error, resulting in an error rate without wrong time error of 7.5% (113/1501). The most frequently administered drugs were the cardiovascular drugs (425/1501, 28.3%). The highest risks of error in a drug administration were for dermatological drugs. No potentially life-threatening errors were witnessed and 6% of errors were classified as having a serious or significant impact on patients (mainly omission). In multivariate analysis, the occurrence of errors was associated with drug administration route, drug classification (ATC) and the number of patient under the nurse's care. Conclusion Medication administration errors are frequent. The identification of its determinants helps to undertake designed interventions. PMID:22409837

Evaluation of drug administration errors in a teaching hospital.

PubMed

Berdot, Sarah; Sabatier, Brigitte; Gillaizeau, Florence; Caruba, Thibaut; Prognon, Patrice; Durieux, Pierre

2012-03-12

Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds). A pharmacist accompanied nurses and witnessed the preparation and administration of drugs to all patients during the three drug rounds on each of six days per ward. Main outcomes were number, type and clinical importance of errors and associated risk factors. Drug administration error rate was calculated with and without wrong time errors. Relationship between the occurrence of errors and potential risk factors were investigated using logistic regression models with random effects. Twenty-eight nurses caring for 108 patients were observed. Among 1501 opportunities for error, 415 administrations (430 errors) with one or more errors were detected (27.6%). There were 312 wrong time errors, ten simultaneously with another type of error, resulting in an error rate without wrong time error of 7.5% (113/1501). The most frequently administered drugs were the cardiovascular drugs (425/1501, 28.3%). The highest risks of error in a drug administration were for dermatological drugs. No potentially life-threatening errors were witnessed and 6% of errors were classified as having a serious or significant impact on patients (mainly omission). In multivariate analysis, the occurrence of errors was associated with drug administration route, drug classification (ATC) and the number of patient under the nurse's care. Medication administration errors are frequent. The identification of its determinants helps to undertake designed interventions.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

...] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About... Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of...ComplianceRegulatoryInformation/default.htm . To receive ``Draft Guidance for Industry and Food and Drug...

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

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75 FR 10806 - Training Program for Regulatory Project Managers; Information Available to Industry

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76 FR 36019 - Amendments to Sterility Test Requirements for Biological Products

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2010-04-01

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Exploiting Redundancy for Flexible Behavior: Unsupervised Learning in a Modular Sensorimotor Control Architecture

ERIC Educational Resources Information Center

Butz, Martin V.; Herbort, Oliver; Hoffmann, Joachim

2007-01-01

Autonomously developing organisms face several challenges when learning reaching movements. First, motor control is learned unsupervised or self-supervised. Second, knowledge of sensorimotor contingencies is acquired in contexts in which action consequences unfold in time. Third, motor redundancies must be resolved. To solve all 3 of these…

Bilingual Lexical Interactions in an Unsupervised Neural Network Model

ERIC Educational Resources Information Center

Zhao, Xiaowei; Li, Ping

2010-01-01

In this paper we present an unsupervised neural network model of bilingual lexical development and interaction. We focus on how the representational structures of the bilingual lexicons can emerge, develop, and interact with each other as a function of the learning history. The results show that: (1) distinct representations for the two lexicons…

A Novel Unsupervised Adaptive Learning Method for Long-Term Electromyography (EMG) Pattern Recognition

PubMed Central

Huang, Qi; Yang, Dapeng; Jiang, Li; Zhang, Huajie; Liu, Hong; Kotani, Kiyoshi

2017-01-01

Performance degradation will be caused by a variety of interfering factors for pattern recognition-based myoelectric control methods in the long term. This paper proposes an adaptive learning method with low computational cost to mitigate the effect in unsupervised adaptive learning scenarios. We presents a particle adaptive classifier (PAC), by constructing a particle adaptive learning strategy and universal incremental least square support vector classifier (LS-SVC). We compared PAC performance with incremental support vector classifier (ISVC) and non-adapting SVC (NSVC) in a long-term pattern recognition task in both unsupervised and supervised adaptive learning scenarios. Retraining time cost and recognition accuracy were compared by validating the classification performance on both simulated and realistic long-term EMG data. The classification results of realistic long-term EMG data showed that the PAC significantly decreased the performance degradation in unsupervised adaptive learning scenarios compared with NSVC (9.03% ± 2.23%, p < 0.05) and ISVC (13.38% ± 2.62%, p = 0.001), and reduced the retraining time cost compared with ISVC (2 ms per updating cycle vs. 50 ms per updating cycle). PMID:28608824

A Novel Unsupervised Adaptive Learning Method for Long-Term Electromyography (EMG) Pattern Recognition.

PubMed

Huang, Qi; Yang, Dapeng; Jiang, Li; Zhang, Huajie; Liu, Hong; Kotani, Kiyoshi

2017-06-13

Performance degradation will be caused by a variety of interfering factors for pattern recognition-based myoelectric control methods in the long term. This paper proposes an adaptive learning method with low computational cost to mitigate the effect in unsupervised adaptive learning scenarios. We presents a particle adaptive classifier (PAC), by constructing a particle adaptive learning strategy and universal incremental least square support vector classifier (LS-SVC). We compared PAC performance with incremental support vector classifier (ISVC) and non-adapting SVC (NSVC) in a long-term pattern recognition task in both unsupervised and supervised adaptive learning scenarios. Retraining time cost and recognition accuracy were compared by validating the classification performance on both simulated and realistic long-term EMG data. The classification results of realistic long-term EMG data showed that the PAC significantly decreased the performance degradation in unsupervised adaptive learning scenarios compared with NSVC (9.03% ± 2.23%, p < 0.05) and ISVC (13.38% ± 2.62%, p = 0.001), and reduced the retraining time cost compared with ISVC (2 ms per updating cycle vs. 50 ms per updating cycle).

Relationships of parental monitoring and emotion regulation with early adolescents' sexual behaviors.

PubMed

Hadley, Wendy; Houck, Christopher D; Barker, David; Senocak, Natali

2015-06-01

The purpose of this study was to examine the moderating influence of parental monitoring (e.g., unsupervised time with opposite sex peers) and adolescent emotional competence on sexual behaviors, among a sample of at-risk early adolescents. This study included 376 seventh-grade adolescents (age, 12-14 years) with behavioral or emotional difficulties. Questionnaires were completed on private laptop computers and assessed adolescent Emotional Competence (including Regulation and Negativity/Lability), Unsupervised Time, and a range of Sexual Behaviors. Generalized linear models were used to evaluate the independent and combined influence of Emotional Competency and Unsupervised Time on adolescent report of Sexual Behaviors. Analyses were stratified by gender to account for the notable gender differences in the targeted moderators and outcome variables. Findings indicated that more unsupervised time was a risk factor for all youth but was influenced by an adolescent's ability to regulate their emotions. Specifically, for males and females, poorer Emotion Regulation was associated with having engaged in a greater variety of Sexual Behaviors. However, lower Negativity/Lability and >1× per week Unsupervised Time were associated with a higher number of sexual behaviors among females only. Based on the findings of this study, a lack of parental supervision seems to be particularly problematic for both male and female adolescents with poor emotion regulation abilities. It may be important to impact both emotion regulation abilities and increase parental knowledge and skills associated with effective monitoring to reduce risk-taking for these youth.

A Novel Unsupervised Segmentation Quality Evaluation Method for Remote Sensing Images

PubMed Central

Tang, Yunwei; Jing, Linhai; Ding, Haifeng

2017-01-01

The segmentation of a high spatial resolution remote sensing image is a critical step in geographic object-based image analysis (GEOBIA). Evaluating the performance of segmentation without ground truth data, i.e., unsupervised evaluation, is important for the comparison of segmentation algorithms and the automatic selection of optimal parameters. This unsupervised strategy currently faces several challenges in practice, such as difficulties in designing effective indicators and limitations of the spectral values in the feature representation. This study proposes a novel unsupervised evaluation method to quantitatively measure the quality of segmentation results to overcome these problems. In this method, multiple spectral and spatial features of images are first extracted simultaneously and then integrated into a feature set to improve the quality of the feature representation of ground objects. The indicators designed for spatial stratified heterogeneity and spatial autocorrelation are included to estimate the properties of the segments in this integrated feature set. These two indicators are then combined into a global assessment metric as the final quality score. The trade-offs of the combined indicators are accounted for using a strategy based on the Mahalanobis distance, which can be exhibited geometrically. The method is tested on two segmentation algorithms and three testing images. The proposed method is compared with two existing unsupervised methods and a supervised method to confirm its capabilities. Through comparison and visual analysis, the results verified the effectiveness of the proposed method and demonstrated the reliability and improvements of this method with respect to other methods. PMID:29064416

Color normalization of histology slides using graph regularized sparse NMF

NASA Astrophysics Data System (ADS)

Sha, Lingdao; Schonfeld, Dan; Sethi, Amit

2017-03-01

Computer based automatic medical image processing and quantification are becoming popular in digital pathology. However, preparation of histology slides can vary widely due to differences in staining equipment, procedures and reagents, which can reduce the accuracy of algorithms that analyze their color and texture information. To re- duce the unwanted color variations, various supervised and unsupervised color normalization methods have been proposed. Compared with supervised color normalization methods, unsupervised color normalization methods have advantages of time and cost efficient and universal applicability. Most of the unsupervised color normaliza- tion methods for histology are based on stain separation. Based on the fact that stain concentration cannot be negative and different parts of the tissue absorb different stains, nonnegative matrix factorization (NMF), and particular its sparse version (SNMF), are good candidates for stain separation. However, most of the existing unsupervised color normalization method like PCA, ICA, NMF and SNMF fail to consider important information about sparse manifolds that its pixels occupy, which could potentially result in loss of texture information during color normalization. Manifold learning methods like Graph Laplacian have proven to be very effective in interpreting high-dimensional data. In this paper, we propose a novel unsupervised stain separation method called graph regularized sparse nonnegative matrix factorization (GSNMF). By considering the sparse prior of stain concentration together with manifold information from high-dimensional image data, our method shows better performance in stain color deconvolution than existing unsupervised color deconvolution methods, especially in keeping connected texture information. To utilized the texture information, we construct a nearest neighbor graph between pixels within a spatial area of an image based on their distances using heat kernal in lαβ space. The representation of a pixel in the stain density space is constrained to follow the feature distance of the pixel to pixels in the neighborhood graph. Utilizing color matrix transfer method with the stain concentrations found using our GSNMF method, the color normalization performance was also better than existing methods.

Unsupervised discovery of information structure in biomedical documents.

PubMed

Kiela, Douwe; Guo, Yufan; Stenius, Ulla; Korhonen, Anna

2015-04-01

Information structure (IS) analysis is a text mining technique, which classifies text in biomedical articles into categories that capture different types of information, such as objectives, methods, results and conclusions of research. It is a highly useful technique that can support a range of Biomedical Text Mining tasks and can help readers of biomedical literature find information of interest faster, accelerating the highly time-consuming process of literature review. Several approaches to IS analysis have been presented in the past, with promising results in real-world biomedical tasks. However, all existing approaches, even weakly supervised ones, require several hundreds of hand-annotated training sentences specific to the domain in question. Because biomedicine is subject to considerable domain variation, such annotations are expensive to obtain. This makes the application of IS analysis across biomedical domains difficult. In this article, we investigate an unsupervised approach to IS analysis and evaluate the performance of several unsupervised methods on a large corpus of biomedical abstracts collected from PubMed. Our best unsupervised algorithm (multilevel-weighted graph clustering algorithm) performs very well on the task, obtaining over 0.70 F scores for most IS categories when applied to well-known IS schemes. This level of performance is close to that of lightly supervised IS methods and has proven sufficient to aid a range of practical tasks. Thus, using an unsupervised approach, IS could be applied to support a wide range of tasks across sub-domains of biomedicine. We also demonstrate that unsupervised learning brings novel insights into IS of biomedical literature and discovers information categories that are not present in any of the existing IS schemes. The annotated corpus and software are available at http://www.cl.cam.ac.uk/∼dk427/bio14info.html. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Effects of an off-season conditioning program on the physical characteristics of adolescent rugby union players.

PubMed

Smart, Daniel J; Gill, Nicholas D

2013-03-01

The aims of the study were to determine if a supervised off-season conditioning program enhanced gains in physical characteristics compared with the same program performed in an unsupervised manner and to establish the persistence of the physical changes after a 6-month unsupervised competition period. Forty-four provincial representative adolescent rugby union players (age, mean ± SD, 15.3 ± 1.3 years) participated in a 15-week off-season conditioning program either under supervision from an experienced strength and conditioning coach or unsupervised. Measures of body composition, strength, vertical jump, speed, and anaerobic and aerobic running performance were taken, before, immediately after, and 6 months after the conditioning. Post conditioning program the supervised group had greater improvements in all strength measures than the unsupervised group, with small, moderate and large differences between the groups\\x{2019} changes for chin-ups (9.1%; ± 11.6%), bench-press (16.9%; ± 11.7%) and box-squat (50.4%; ± 20.9%) estimated 1RM respectively. Both groups showed trivial increases in mass; however increases in fat free mass were small and trivial for supervised and unsupervised players respectively. Strength declined in the supervised group while the unsupervised group had small increases during the competition phase, resulting in only a small difference between the long-term changes in box-squat 1RM (15.9%; ± 13.2%). The supervised group had further small increases in fat free mass resulting in a small difference (2.4%; ± 2.7%) in the long-term changes. The postconditioning differences between the 2 groups may have been a result of increased adherence and the attainment of higher training loads during supervised training. The lack of differences in strength after the competition period indicates that supervision should be maintained to reduce substantial decrements in performance.

Shortage of Peritoneal Dialysis Solution and the Food and Drug Administration's Response.

PubMed

Jensen, Valerie; Throckmorton, Douglas C

2015-08-07

Although the number of new drug shortages has been lower in recent years than in the past, severe shortages have occurred that have affected large numbers of patients. A new law entitled the Food and Drug Administration Safety and Innovation Act was enacted in July of 2012, which requires companies to notify the Food and Drug Administration of anticipated shortages. This notification requirement has allowed the Food and Drug Administration to work closely with manufacturers earlier to mitigate and, often, prevent shortages. However, not all shortages are able to be prevented, and the shortage of peritoneal dialysis solution is one that has had a significant effect on patients. The Food and Drug Administration continues to use all available tools to address this shortage with manufacturers, including temporary availability of imported peritoneal dialysis solution from Ireland. Mitigating shortages is a top priority for the Food and Drug Administration, and communication with all stakeholders is essential. Copyright © 2015 by the American Society of Nephrology.

Solid‐in‐oil nanodispersions for transdermal drug delivery systems

PubMed Central

Kitaoka, Momoko; Wakabayashi, Rie; Kamiya, Noriho

2016-01-01

Abstract Transdermal administration of drugs has advantages over conventional oral administration or administration using injection equipment. The route of administration reduces the opportunity for drug evacuation before systemic circulation, and enables long‐lasting drug administration at a modest body concentration. In addition, the skin is an attractive route for vaccination, because there are many immune cells in the skin. Recently, solid‐in‐oil nanodisperison (S/O) technique has demonstrated to deliver cosmetic and pharmaceutical bioactives efficiently through the skin. S/O nanodispersions are nanosized drug carriers designed to overcome the skin barrier. This review discusses the rationale for preparation of efficient and stable S/O nanodispersions, as well as application examples in cosmetic and pharmaceutical materials including vaccines. Drug administration using a patch is user‐friendly, and may improve patient compliance. The technique is a potent transcutaneous immunization method without needles. PMID:27529824

Solid-in-oil nanodispersions for transdermal drug delivery systems.

PubMed

Kitaoka, Momoko; Wakabayashi, Rie; Kamiya, Noriho; Goto, Masahiro

2016-11-01

Transdermal administration of drugs has advantages over conventional oral administration or administration using injection equipment. The route of administration reduces the opportunity for drug evacuation before systemic circulation, and enables long-lasting drug administration at a modest body concentration. In addition, the skin is an attractive route for vaccination, because there are many immune cells in the skin. Recently, solid-in-oil nanodisperison (S/O) technique has demonstrated to deliver cosmetic and pharmaceutical bioactives efficiently through the skin. S/O nanodispersions are nanosized drug carriers designed to overcome the skin barrier. This review discusses the rationale for preparation of efficient and stable S/O nanodispersions, as well as application examples in cosmetic and pharmaceutical materials including vaccines. Drug administration using a patch is user-friendly, and may improve patient compliance. The technique is a potent transcutaneous immunization method without needles. © 2016 The Authors. Biotechnology Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

21 CFR 19.10 - Food and Drug Administration Conflict of Interest Review Board.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration Conflict of Interest... HUMAN SERVICES GENERAL STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST General Provisions § 19.10 Food and Drug Administration Conflict of Interest Review Board. (a) The Commissioner shall establish a...

78 FR 10181 - Global Quality Systems-An Integrated Approach To Improving Medical Product Safety; Public Workshop

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2013-02-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001... AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) Cincinnati District Office, in cosponsorship with the Association of Food and Drug Officials...

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2012-08-30

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2011-03-09

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2012-09-17

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21 CFR 20.30 - Food and Drug Administration Freedom of Information Staff.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration Freedom of... HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.30 Food and Drug Administration Freedom of Information Staff. (a) The Office responsible for agency compliance with the Freedom of Information Act and...

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2013-08-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0002...; Tylosin; Virginiamycin AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...: David Alterman, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl...

76 FR 72954 - Request for Nominations for Voting Members on Public Advisory Committee, Science Board to the...

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2011-11-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Request for Nominations for Voting Members on Public Advisory Committee, Science Board to the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug...

76 FR 6475 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0603... Request; Animal Drug User Fees and Fee Waivers and Reductions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection...

78 FR 14306 - International Cooperation on Harmonisation of Technical Requirements for Registration of...

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2013-03-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2000-D-0598... Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing'' (VICH GL23(R)); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

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

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2013-07-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

77 FR 8885 - Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the...

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2012-02-15

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

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2012-04-03

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75 FR 59721 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0356... Request; Designated New Animal Drugs for Minor Use and Minor Species AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed...

75 FR 42094 - Agency Information Collection Activities; Proposed Collection; Comment Request; Designated New...

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2010-07-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0356... Drugs for Minor Use and Minor Species AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed...

78 FR 71623 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

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2013-11-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0716... Request; Designated New Animal Drugs for Minor Use and Minor Species AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed...

77 FR 43844 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User...

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2012-07-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0748... Cover Sheet; Form FDA 3794 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed...

77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

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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...

76 FR 3910 - Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0015... Designation (Form FDA 3671) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of...

78 FR 27969 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1131... Request; New Animal Drug Applications and Supporting Regulations and Form FDA 356V AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a...

77 FR 64523 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0471... Request; Prescription Drug User Fee Cover Sheet; Form FDA 3397 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection...

78 FR 48689 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0471...; Prescription Drug User Fee Cover Sheet; Form FDA 3397 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled...

78 FR 35277 - Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-12

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0653... Designation (Form FDA 3671) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of...

77 FR 41984 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0708... Request; Form FDA 3728, Animal Generic Drug User Fee Act Cover Sheet AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed...

77 FR 69630 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1131... Applications and Supporting Regulations, and Form FDA 356V AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment...

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...

77 FR 66620 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0748... Request; Generic Drug User Fee Cover Sheet; Form FDA 3794 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection...

78 FR 66745 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-06

... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7520 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...

78 FR 37230 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-20

... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...

75 FR 45646 - Design of Clinical Trials of Aerosolized Antimicrobials for the Treatment of Cystic Fibrosis...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

... Drug Evaluation and Research,Food and Drug Administration, Office of Antimicrobial Products, 10903 New... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food...

77 FR 10536 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver..., Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...

77 FR 74669 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-17

... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...

78 FR 15017 - Guidance for Industry: What You Need To Know About Administrative Detention of Foods; Small...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0643... Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled...

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...

Advanced Analgesic Drug Delivery and Nanobiotechnology.

PubMed

Stoicea, Nicoleta; Fiorda-Diaz, Juan; Joseph, Nicholas; Shabsigh, Muhammad; Arias-Morales, Carlos; Gonzalez-Zacarias, Alicia A; Mavarez-Martinez, Ana; Marjoribanks, Stephen; Bergese, Sergio D

2017-07-01

Transdermal administration of analgesic medications offers several benefits over alternative routes of administration, including a decreased systemic drug load with fewer side effects, and avoidance of drug degradation by the gastrointestinal tract. Transdermal administration also offers a convenient mode of drug administration over an extended period of time, particularly desirable in pain medicine. A transdermal administration route may also offer increased safety for drugs with a narrow therapeutic window. The primary barrier to transdermal drug absorption is the skin itself. Transdermal nanotechnology offers a novel method of achieving enhanced dermal penetration with an extended delivery profile for analgesic drugs, due to their small size and relatively large surface area. Several materials have been used to enhance drug duration and transdermal penetration. The application of nanotechnology in transdermal delivery of analgesics has raised new questions regarding safety and ethical issues. The small molecular size of nanoparticles enables drug delivery to previously inaccessible body sites. To ensure safety, the interaction of nanoparticles with the human body requires further investigation on an individual drug basis, since different formulations have unique properties and side effects.

77 FR 8262 - Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0081] Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

Preclinical Determinants of Drug Choice under Concurrent Schedules of Drug Self-Administration

PubMed Central

Banks, Matthew L.; Negus, S. Stevens

2012-01-01

Drug self-administration procedures have played a critical role in the experimental analysis of psychoactive compounds, such as cocaine, for over 50 years. While there are numerous permutations of this procedure, this paper will specifically focus on choice procedures using concurrent schedules of intravenous drug self-administration. The aims of this paper are to first highlight the evolution of drug choice procedures and then review the subsequent preclinical body of literature utilizing these choice procedures to understand the environmental, pharmacological, and biological determinants of the reinforcing stimulus effects of drugs. A main rationale for this paper is our proposition that choice schedules are underutilized in investigating the reinforcing effects of drugs in assays of drug self-administration. Moreover, we will conclude with potential future directions and unexplored scientific space for the use of drug choice procedures. PMID:23243420

Combining Unsupervised and Supervised Classification to Build User Models for Exploratory Learning Environments

ERIC Educational Resources Information Center

Amershi, Saleema; Conati, Cristina

2009-01-01

In this paper, we present a data-based user modeling framework that uses both unsupervised and supervised classification to build student models for exploratory learning environments. We apply the framework to build student models for two different learning environments and using two different data sources (logged interface and eye-tracking data).…

Unsupervised Discovery of Nonlinear Structure Using Contrastive Backpropagation

ERIC Educational Resources Information Center

Hinton, Geoffrey; Osindero, Simon; Welling, Max; Teh, Yee-Whye

2006-01-01

We describe a way of modeling high-dimensional data vectors by using an unsupervised, nonlinear, multilayer neural network in which the activity of each neuron-like unit makes an additive contribution to a global energy score that indicates how surprised the network is by the data vector. The connection weights that determine how the activity of…

Validation of Unsupervised Computer-Based Screening for Reading Disability in Greek Elementary Grades 3 and 4

ERIC Educational Resources Information Center

Protopapas, Athanassios; Skaloumbakas, Christos; Bali, Persefoni

2008-01-01

After reviewing past efforts related to computer-based reading disability (RD) assessment, we present a fully automated screening battery that evaluates critical skills relevant for RD diagnosis designed for unsupervised application in the Greek educational system. Psychometric validation in 301 children, 8-10 years old (grades 3 and 4; including…

Unsupervised classification of remote multispectral sensing data

NASA Technical Reports Server (NTRS)

Su, M. Y.

1972-01-01

The new unsupervised classification technique for classifying multispectral remote sensing data which can be either from the multispectral scanner or digitized color-separation aerial photographs consists of two parts: (a) a sequential statistical clustering which is a one-pass sequential variance analysis and (b) a generalized K-means clustering. In this composite clustering technique, the output of (a) is a set of initial clusters which are input to (b) for further improvement by an iterative scheme. Applications of the technique using an IBM-7094 computer on multispectral data sets over Purdue's Flight Line C-1 and the Yellowstone National Park test site have been accomplished. Comparisons between the classification maps by the unsupervised technique and the supervised maximum liklihood technique indicate that the classification accuracies are in agreement.

Unsupervised learning in probabilistic neural networks with multi-state metal-oxide memristive synapses

NASA Astrophysics Data System (ADS)

Serb, Alexander; Bill, Johannes; Khiat, Ali; Berdan, Radu; Legenstein, Robert; Prodromakis, Themis

2016-09-01

In an increasingly data-rich world the need for developing computing systems that cannot only process, but ideally also interpret big data is becoming continuously more pressing. Brain-inspired concepts have shown great promise towards addressing this need. Here we demonstrate unsupervised learning in a probabilistic neural network that utilizes metal-oxide memristive devices as multi-state synapses. Our approach can be exploited for processing unlabelled data and can adapt to time-varying clusters that underlie incoming data by supporting the capability of reversible unsupervised learning. The potential of this work is showcased through the demonstration of successful learning in the presence of corrupted input data and probabilistic neurons, thus paving the way towards robust big-data processors.

Classification of earth terrain using polarimetric synthetic aperture radar images

NASA Technical Reports Server (NTRS)

Lim, H. H.; Swartz, A. A.; Yueh, H. A.; Kong, J. A.; Shin, R. T.; Van Zyl, J. J.

1989-01-01

Supervised and unsupervised classification techniques are developed and used to classify the earth terrain components from SAR polarimetric images of San Francisco Bay and Traverse City, Michigan. The supervised techniques include the Bayes classifiers, normalized polarimetric classification, and simple feature classification using discriminates such as the absolute and normalized magnitude response of individual receiver channel returns and the phase difference between receiver channels. An algorithm is developed as an unsupervised technique which classifies terrain elements based on the relationship between the orientation angle and the handedness of the transmitting and receiving polariation states. It is found that supervised classification produces the best results when accurate classifier training data are used, while unsupervised classification may be applied when training data are not available.

21 CFR 312.140 - Address for correspondence.

Code of Federal Regulations, 2010 CFR

2010-04-01

... submission to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug... Generic Drugs (HFD-600), Center for Drug Evaluation and Research, Food and Drug Administration, Metro Park... Evaluation and Research, Food and Drug Administration, 12229 Wilkins Ave., Rockville, MD 20852. (3) For...

21 CFR 312.140 - Address for correspondence.

Code of Federal Regulations, 2011 CFR

2011-04-01

... submission to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug... Generic Drugs (HFD-600), Center for Drug Evaluation and Research, Food and Drug Administration, Metro Park... Evaluation and Research, Food and Drug Administration, 12229 Wilkins Ave., Rockville, MD 20852. (3) For...

75 FR 6209 - Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0410] (formerly Docket No. 2006D-0191) Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials; Availability AGENCY: Food and Drug...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0281] Draft Guidance for Industry and Food and Drug Administration Staff; ```Harmful and Potentially Harmful... Food, Drug, and Cosmetic Act.'' This draft guidance provides written guidance to industry and FDA staff...

78 FR 17932 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-25

... Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(3)). In addition, the current good manufacturing... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0033... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

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 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 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 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 3 2013-04-01 2013-04-01 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 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 3 2012-04-01 2012-04-01 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 118.9 - Administration of the Salmonella Enteritidis (SE) prevention plan.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Administration of the Salmonella Enteritidis (SE) prevention plan. 118.9 Section 118.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... EGGS § 118.9 Administration of the Salmonella Enteritidis (SE) prevention plan. You must have one or...

21 CFR 118.9 - Administration of the Salmonella Enteritidis (SE) prevention plan.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Administration of the Salmonella Enteritidis (SE) prevention plan. 118.9 Section 118.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... EGGS § 118.9 Administration of the Salmonella Enteritidis (SE) prevention plan. You must have one or...

21 CFR 118.9 - Administration of the Salmonella Enteritidis (SE) prevention plan.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Administration of the Salmonella Enteritidis (SE) prevention plan. 118.9 Section 118.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... EGGS § 118.9 Administration of the Salmonella Enteritidis (SE) prevention plan. You must have one or...

21 CFR 118.9 - Administration of the Salmonella Enteritidis (SE) prevention plan.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Administration of the Salmonella Enteritidis (SE) prevention plan. 118.9 Section 118.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... EGGS § 118.9 Administration of the Salmonella Enteritidis (SE) prevention plan. You must have one or...

21 CFR 118.9 - Administration of the Salmonella Enteritidis (SE) prevention plan.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Administration of the Salmonella Enteritidis (SE) prevention plan. 118.9 Section 118.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... EGGS § 118.9 Administration of the Salmonella Enteritidis (SE) prevention plan. You must have one or...

77 FR 55845 - Science Board to the Food and Drug Administration: Request for Nominations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is requesting nominations to serve on the Science Board to FDA (Science Board). FDA seeks to include the views of women and men...

21 CFR 172.809 - Curdlan.

Code of Federal Regulations, 2014 CFR

2014-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES... Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100... Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College...

21 CFR 1316.50 - Appearance; representation; authorization.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Appearance; representation; authorization. 1316.50 Section 1316.50 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.50 Appearance; representation...

Understanding vasopressor intervention and weaning: risk prediction in a public heterogeneous clinical time series database.

PubMed

Wu, Mike; Ghassemi, Marzyeh; Feng, Mengling; Celi, Leo A; Szolovits, Peter; Doshi-Velez, Finale

2017-05-01

The widespread adoption of electronic health records allows us to ask evidence-based questions about the need for and benefits of specific clinical interventions in critical-care settings across large populations. We investigated the prediction of vasopressor administration and weaning in the intensive care unit. Vasopressors are commonly used to control hypotension, and changes in timing and dosage can have a large impact on patient outcomes. We considered a cohort of 15 695 intensive care unit patients without orders for reduced care who were alive 30 days post-discharge. A switching-state autoregressive model (SSAM) was trained to predict the multidimensional physiological time series of patients before, during, and after vasopressor administration. The latent states from the SSAM were used as predictors of vasopressor administration and weaning. The unsupervised SSAM features were able to predict patient vasopressor administration and successful patient weaning. Features derived from the SSAM achieved areas under the receiver operating curve of 0.92, 0.88, and 0.71 for predicting ungapped vasopressor administration, gapped vasopressor administration, and vasopressor weaning, respectively. We also demonstrated many cases where our model predicted weaning well in advance of a successful wean. Models that used SSAM features increased performance on both predictive tasks. These improvements may reflect an underlying, and ultimately predictive, latent state detectable from the physiological time series. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Discrete-choice modelling of patient preferences for modes of drug administration.

PubMed

Tetteh, Ebenezer Kwabena; Morris, Steve; Titcheneker-Hooker, Nigel

2017-12-01

The administration of (biologically-derived) drugs for various disease conditions involves consumption of resources that constitutes a direct monetary cost to healthcare payers and providers. An often ignored cost relates to a mismatch between patients' preferences and the mode of drug administration. The "intangible" benefits of giving patients what they want in terms of the mode of drug delivery is seldom considered. This study aims to evaluate, in monetary terms, end-user preferences for the non-monetary attributes of different modes of drug administration using a discrete-choice experiment. It provides empirical support to the notion that there are significant benefits from developing patient-friendly approaches to drug delivery. The gross benefits per patient per unit administration is in the same order of magnitude as the savings in resource costs of administering drugs. The study argues that, as long as the underlying manufacturing science is capable, a patient-centred approach to producing drug delivery systems should be encouraged and pursued.

Influence of mianserin on the activity of some hypotensive drugs in spontaneously hypertensive rats.

PubMed

Górska, Dorota; Andrzejczak, Dariusz

2003-01-01

Mianserin might be an alternative drug in patients with depression accompanied by hypertension because of its effectiveness and lack of side effects in the circulatory system. However, a few studies reported in literature show influence of the drug on blood pressure. We investigate interactions between mianserin and commonly used hypotensive drugs (propranolol, enalapril and prazosin) in spontaneously hypertensive rats (SHR). The experiments were performed in two experimental designs: a single administration of both mianserin and a hypotensive drug, and repeated administration of mianserin with a single administration of a hypotensive drug. Arterial blood pressure was measured by bloodless method with manometer made by LETICA. A single administration of mianserin caused a statistically significant decrease in systolic, diastolic and mean blood pressure in the 60th minute of observation and intensified hypotensive effect of prazosin. However, long-term administration of mianserin in SHR rats had no significant influence on arterial blood pressure. Chronic and single administration of mianserin with propranolol or enalapril did not influence the circulatory system. A long-term administration of mianserin intensified the hypotensive effect of prazosin. This interaction might suggest possibility of dangerous complications in the treatment of humans with this drug combination.

76 FR 60505 - Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0690] Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

75 FR 24394 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-05

... [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations by...

75 FR 21007 - Food Labeling; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food Labeling; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Dallas...

77 FR 59404 - Food Defense; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food Defense; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest...

21 CFR 1316.63 - Official transcript; index; corrections.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Official transcript; index; corrections. 1316.63 Section 1316.63 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.63 Official transcript; index...

21 CFR 1316.02 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Definitions. 1316.02 Section 1316.02 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.02 Definitions. As used in this subpart, the following terms...

21 CFR 1316.43 - Information; special instructions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Information; special instructions. 1316.43 Section 1316.43 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.43 Information; special instructions. Information...

78 FR 38053 - Regulatory Systems Strengthening

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-25

... Science Policy Analysis/Office of International Programs, HFG-1, Food and Drug Administration, 10903 New... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0010] Regulatory Systems Strengthening AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

76 FR 61563 - Voluntary Surrender of Certificate of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-05

... 21 CFR Part 1301 Administrative practice and procedure, Drug traffic control, Security measures. 21 CFR Part 1309 Administrative practice and procedure, Drug traffic control, Exports, Imports, Security... DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Parts 1301 and 1309 [Docket No. DEA...

United States Food and Drug Administration Product Label Changes

PubMed Central

Sung, Julie C.; Stein-Gold, Linda; Goldenberg, Gary

2017-01-01

Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:28367259

United States Food and Drug Administration Product Label Changes

PubMed Central

Sung, Julie C.; Stein-Gold, Linda; Goldenberg, Gary

2016-01-01

Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:26962391

United States Food and Drug Administration Product Label Changes.

PubMed

Kircik, Leon; Sung, Julie C; Stein-Gold, Linda; Goldenberg, Gary

2017-02-01

Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug.

Automated glioblastoma segmentation based on a multiparametric structured unsupervised classification.

PubMed

Juan-Albarracín, Javier; Fuster-Garcia, Elies; Manjón, José V; Robles, Montserrat; Aparici, F; Martí-Bonmatí, L; García-Gómez, Juan M

2015-01-01

Automatic brain tumour segmentation has become a key component for the future of brain tumour treatment. Currently, most of brain tumour segmentation approaches arise from the supervised learning standpoint, which requires a labelled training dataset from which to infer the models of the classes. The performance of these models is directly determined by the size and quality of the training corpus, whose retrieval becomes a tedious and time-consuming task. On the other hand, unsupervised approaches avoid these limitations but often do not reach comparable results than the supervised methods. In this sense, we propose an automated unsupervised method for brain tumour segmentation based on anatomical Magnetic Resonance (MR) images. Four unsupervised classification algorithms, grouped by their structured or non-structured condition, were evaluated within our pipeline. Considering the non-structured algorithms, we evaluated K-means, Fuzzy K-means and Gaussian Mixture Model (GMM), whereas as structured classification algorithms we evaluated Gaussian Hidden Markov Random Field (GHMRF). An automated postprocess based on a statistical approach supported by tissue probability maps is proposed to automatically identify the tumour classes after the segmentations. We evaluated our brain tumour segmentation method with the public BRAin Tumor Segmentation (BRATS) 2013 Test and Leaderboard datasets. Our approach based on the GMM model improves the results obtained by most of the supervised methods evaluated with the Leaderboard set and reaches the second position in the ranking. Our variant based on the GHMRF achieves the first position in the Test ranking of the unsupervised approaches and the seventh position in the general Test ranking, which confirms the method as a viable alternative for brain tumour segmentation.

Pelvic floor muscle exercises utilizing trunk stabilization for treating postpartum urinary incontinence: randomized controlled pilot trial of supervised versus unsupervised training.

PubMed

Kim, Eun-Young; Kim, Suhn-Yeop; Oh, Duck-Won

2012-02-01

To investigate the effect of supervised and unsupervised pelvic floor muscle exercises utilizing trunk stabilization for treating postpartum urinary incontinence and to compare the outcomes. Randomized, single-blind controlled study. Outpatient rehabilitation hospital. Eighteen subjects with postpartum urinary incontinence. Subjects were randomized to either a supervised training group with verbal instruction from a physiotherapist, or an unsupervised training group after undergoing a supervised demonstration session. Bristol Female Lower Urinary Tract Symptom questionnaire (urinary symptoms and quality of life) and vaginal function test (maximal vaginal squeeze pressure and holding time) using a perineometer. The change values for urinary symptoms (-27.22 ± 6.20 versus -18.22 ± 5.49), quality of life (-5.33 ± 2.96 versus -1.78 ± 3.93), total score (-32.56 ± 8.17 versus -20.00 ± 6.67), maximal vaginal squeeze pressure (18.96 ± 9.08 versus 2.67 ± 3.64 mmHg), and holding time (11.32 ± 3.17 versus 5.72 ± 2.29 seconds) were more improved in the supervised group than in the unsupervised group (P < 0.05). In the supervised group, significant differences were found for all variables between pre- and post-test values (P < 0.01), whereas the unsupervised group showed significant differences for urinary symptom score, total score and holding time between the pre- and post-test results (P < 0.05). These findings suggest that exercising the pelvic floor muscles by utilizing trunk stabilization under physiotherapist supervision may be beneficial for the management of postpartum urinary incontinence.

Safeguarding the process of drug administration with an emphasis on electronic support tools

PubMed Central

Seidling, Hanna M; Lampert, Anette; Lohmann, Kristina; Schiele, Julia T; Send, Alexander J F; Witticke, Diana; Haefeli, Walter E

2013-01-01

Aims The aim of this work is to understand the process of drug administration and identify points in the workflow that resulted in interventions by clinical information systems in order to improve patient safety. Methods To identify a generic way to structure the drug administration process we performed peer-group discussions and supplemented these discussions with a literature search for studies reporting errors in drug administration and strategies for their prevention. Results We concluded that the drug administration process might consist of up to 11 sub-steps, which can be grouped into the four sub-processes of preparation, personalization, application and follow-up. Errors in drug handling and administration are diverse and frequent and in many cases not caused by the patient him/herself, but by family members or nurses. Accordingly, different prevention strategies have been set in place with relatively few approaches involving e-health technology. Conclusions A generic structuring of the administration process and particular error-prone sub-steps may facilitate the allocation of prevention strategies and help to identify research gaps. PMID:24007450

21 CFR 314.98 - Postmarketing reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Postmarketing reports. 314.98 Section 314.98 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR...

77 FR 59624 - Gastrointestinal Drugs Advisory Committee; Notice of Postponement of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-28

... FURTHER INFORMATION CONTACT: Cindy Hong, Center for Drug Evaluation and Research, Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastrointestinal Drugs Advisory Committee; Notice of Postponement of Meeting AGENCY: Food and Drug Administration...

75 FR 37295 - Change of Address; Abbreviated New Drug Applications; Technical Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-29

..., 2010. FOR FURTHER INFORMATION CONTACT: Martin Shimer, Center for Drug Evaluation and Research, Food and... Drugs (HFD-600), Center for Drug Evaluation and Research, Food and Drug Administration, Metro Park North... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 312 and 314...

21 CFR 500.46 - Hexachlorophene in animal drugs.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Hexachlorophene in animal drugs. 500.46 Section 500.46 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS GENERAL Specific Administrative Rulings and Decisions § 500.46...

21 CFR 500.46 - Hexachlorophene in animal drugs.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Hexachlorophene in animal drugs. 500.46 Section 500.46 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS GENERAL Specific Administrative Rulings and Decisions § 500.46...

76 FR 38554 - Oral Dosage Form New Animal Drugs; Amprolium

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

.... FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Amprolium AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Cross...

77 FR 4226 - Oral Dosage Form New Animal Drugs; Gentamicin Sulfate

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-27

.... FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Gentamicin Sulfate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA...

75 FR 76259 - Oral Dosage Form New Animal Drugs; Tylosin

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-08

.... FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by...

75 FR 11451 - New Animal Drugs for Use in Animal Feeds; Zilpaterol

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-11

.... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Zilpaterol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of three abbreviated new animal drug applications (ANADAs) filed...

75 FR 54492 - Oral Dosage Form New Animal Drugs; Tiamulin

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-08

.... FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Tiamulin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal...

21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Drug Administration is providing guidelines that manufacturers may use in testing for effectiveness...

21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Drug Administration is providing guidelines that manufacturers may use in testing for effectiveness...

21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Drug Administration is providing guidelines that manufacturers may use in testing for effectiveness...

21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Drug Administration is providing guidelines that manufacturers may use in testing for effectiveness...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

...] Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information...

Chemotherapeutic response to cisplatin-like drugs in human breast cancer cells probed by vibrational microspectroscopy.

PubMed

Batista de Carvalho, A L M; Pilling, M; Gardner, P; Doherty, J; Cinque, G; Wehbe, K; Kelley, C; Batista de Carvalho, L A E; Marques, M P M

2016-06-23

Studies of drug-cell interactions in cancer model systems are essential in the preclinical stage of rational drug design, which relies on a thorough understanding of the mechanisms underlying cytotoxic activity and biological effects, at a molecular level. This study aimed at applying complementary vibrational spectroscopy methods to evaluate the cellular impact of two Pt(ii) and Pd(ii) dinuclear chelates with spermine (Pt2Spm and Pd2Spm), using cisplatin (cis-Pt(NH3)2Cl2) as a reference compound. Their effects on cellular metabolism were monitored in a human triple-negative metastatic breast cancer cell line (MDA-MB-231) by Raman and synchrotron-radiation infrared microspectroscopies, for different drug concentrations (2-8 μM) at 48 h exposure. Multivariate data analysis was applied (unsupervised PCA), unveiling drug- and concentration-dependent effects: apart from discrimination between control and drug-treated cells, a clear separation was obtained for the different agents studied - mononuclear vs. polynuclear, and Pt(ii) vs. Pd(ii). Spectral biomarkers of drug action were identified, as well as the cellular response to the chemotherapeutic insult. The main effect of the tested compounds was found to be on DNA, lipids and proteins, the Pd(ii) agent having a more significant impact on proteins while its Pt(ii) homologue affected the cellular lipid content at lower concentrations, which suggests the occurrence of distinct and unconventional pathways of cytotoxicity for these dinuclear polyamine complexes. Raman and FTIR microspectroscopies were confirmed as powerful non-invasive techniques to obtain unique spectral signatures of the biochemical impact and physiological reaction of cells to anticancer agents.

Hanging out with Which Friends? Friendship-Level Predictors of Unstructured and Unsupervised Socializing in Adolescence

ERIC Educational Resources Information Center

Siennick, Sonja E.; Osgood, D. Wayne

2012-01-01

Companions are central to explanations of the risky nature of unstructured and unsupervised socializing, yet we know little about whom adolescents are with when hanging out. We examine predictors of how often friendship dyads hang out via multilevel analyses of longitudinal friendship-level data on over 5,000 middle schoolers. Adolescents hang out…

Teacher and learner: Supervised and unsupervised learning in communities.

PubMed

Shafto, Michael G; Seifert, Colleen M

2015-01-01

How far can teaching methods go to enhance learning? Optimal methods of teaching have been considered in research on supervised and unsupervised learning. Locally optimal methods are usually hybrids of teaching and self-directed approaches. The costs and benefits of specific methods have been shown to depend on the structure of the learning task, the learners, the teachers, and the environment.

77 FR 12313 - Food Labeling Workshop; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food Labeling Workshop; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Dallas...

75 FR 29775 - Food Labeling Workshop; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2010-N-0001] Food and Drug Administration Food Labeling Workshop; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest...

75 FR 74736 - Food Labeling Workshop; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food Labeling Workshop; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest...

21 CFR 1316.42 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Definitions. 1316.42 Section 1316.42 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.42 Definitions. As used in this subpart, the following terms shall...

21 CFR 1316.55 - Prehearing ruling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Prehearing ruling. 1316.55 Section 1316.55 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.55 Prehearing ruling. The presiding officer may have the...

21 CFR 1316.06 - Notice of inspection.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Notice of inspection. 1316.06 Section 1316.06 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.06 Notice of inspection. The notice of inspection...

21 CFR 1316.61 - Exceptions to rulings.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Exceptions to rulings. 1316.61 Section 1316.61 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.61 Exceptions to rulings. Exceptions to rulings of...

21 CFR 1316.04 - Exclusion from inspection.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Exclusion from inspection. 1316.04 Section 1316.04 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.04 Exclusion from inspection. (a) Unless the...

21 CFR 1316.66 - Exceptions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Exceptions. 1316.66 Section 1316.66 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.66 Exceptions. (a) Within twenty days after the date upon which a...

21 CFR 1316.45 - Filings; address; hours.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Filings; address; hours. 1316.45 Section 1316.45 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.45 Filings; address; hours. Documents required or...

75 FR 32140 - Voluntary Surrender of Certificate of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-07

... 21 CFR Part 1301 Administrative practice and procedure, Drug traffic control, Security measures. 21 CFR Part 1309 Administrative practice and procedure, Drug traffic control, Exports, Imports, Security... DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Parts 1301, 1309 [Docket No. DEA-304P...

76 FR 4919 - Regulatory Site Visit Training Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0046] Regulatory Site Visit Training Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is...

75 FR 6404 - Regulatory Site Visit Training Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0045] (formerly Docket No. 2004N-0408) Regulatory Site Visit Training Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Biologics...

75 FR 77906 - Agency Information Collection Activities: Proposed Collection; Comments Requested: Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-14

..., Human Resources Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152... collection: Form number: DEA Form 341. Component: Human Resources Division, Drug Enforcement Administration... Administration (DEA), will be submitting the following information collection request to the Office of Management...

77 FR 7588 - Blood Products Advisory Committee; Cancellation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Blood Products Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION... Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, Contact 1- 301...

75 FR 15342 - Advisory Committees; Technical Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 [Docket No. FDA-2010-N-0001] Advisory Committees; Technical Amendment Agency: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending its...

Unsupervised hierarchical partitioning of hyperspectral images: application to marine algae identification

NASA Astrophysics Data System (ADS)

Chen, B.; Chehdi, K.; De Oliveria, E.; Cariou, C.; Charbonnier, B.

2015-10-01

In this paper a new unsupervised top-down hierarchical classification method to partition airborne hyperspectral images is proposed. The unsupervised approach is preferred because the difficulty of area access and the human and financial resources required to obtain ground truth data, constitute serious handicaps especially over large areas which can be covered by airborne or satellite images. The developed classification approach allows i) a successive partitioning of data into several levels or partitions in which the main classes are first identified, ii) an estimation of the number of classes automatically at each level without any end user help, iii) a nonsystematic subdivision of all classes of a partition Pj to form a partition Pj+1, iv) a stable partitioning result of the same data set from one run of the method to another. The proposed approach was validated on synthetic and real hyperspectral images related to the identification of several marine algae species. In addition to highly accurate and consistent results (correct classification rate over 99%), this approach is completely unsupervised. It estimates at each level, the optimal number of classes and the final partition without any end user intervention.

Unsupervised learning of discriminative edge measures for vehicle matching between nonoverlapping cameras.

PubMed

Shan, Ying; Sawhney, Harpreet S; Kumar, Rakesh

2008-04-01

This paper proposes a novel unsupervised algorithm learning discriminative features in the context of matching road vehicles between two non-overlapping cameras. The matching problem is formulated as a same-different classification problem, which aims to compute the probability of vehicle images from two distinct cameras being from the same vehicle or different vehicle(s). We employ a novel measurement vector that consists of three independent edge-based measures and their associated robust measures computed from a pair of aligned vehicle edge maps. The weight of each measure is determined by an unsupervised learning algorithm that optimally separates the same-different classes in the combined measurement space. This is achieved with a weak classification algorithm that automatically collects representative samples from same-different classes, followed by a more discriminative classifier based on Fisher' s Linear Discriminants and Gibbs Sampling. The robustness of the match measures and the use of unsupervised discriminant analysis in the classification ensures that the proposed method performs consistently in the presence of missing/false features, temporally and spatially changing illumination conditions, and systematic misalignment caused by different camera configurations. Extensive experiments based on real data of over 200 vehicles at different times of day demonstrate promising results.

Multispectral and Panchromatic used Enhancement Resolution and Study Effective Enhancement on Supervised and Unsupervised Classification Land – Cover

NASA Astrophysics Data System (ADS)

Salman, S. S.; Abbas, W. A.

2018-05-01

The goal of the study is to support analysis Enhancement of Resolution and study effect on classification methods on bands spectral information of specific and quantitative approaches. In this study introduce a method to enhancement resolution Landsat 8 of combining the bands spectral of 30 meters resolution with panchromatic band 8 of 15 meters resolution, because of importance multispectral imagery to extracting land - cover. Classification methods used in this study to classify several lands -covers recorded from OLI- 8 imagery. Two methods of Data mining can be classified as either supervised or unsupervised. In supervised methods, there is a particular predefined target, that means the algorithm learn which values of the target are associated with which values of the predictor sample. K-nearest neighbors and maximum likelihood algorithms examine in this work as supervised methods. In other hand, no sample identified as target in unsupervised methods, the algorithm of data extraction searches for structure and patterns between all the variables, represented by Fuzzy C-mean clustering method as one of the unsupervised methods, NDVI vegetation index used to compare the results of classification method, the percent of dense vegetation in maximum likelihood method give a best results.

Learning representation hierarchies by sharing visual features: a computational investigation of Persian character recognition with unsupervised deep learning.

PubMed

Sadeghi, Zahra; Testolin, Alberto

2017-08-01

In humans, efficient recognition of written symbols is thought to rely on a hierarchical processing system, where simple features are progressively combined into more abstract, high-level representations. Here, we present a computational model of Persian character recognition based on deep belief networks, where increasingly more complex visual features emerge in a completely unsupervised manner by fitting a hierarchical generative model to the sensory data. Crucially, high-level internal representations emerging from unsupervised deep learning can be easily read out by a linear classifier, achieving state-of-the-art recognition accuracy. Furthermore, we tested the hypothesis that handwritten digits and letters share many common visual features: A generative model that captures the statistical structure of the letters distribution should therefore also support the recognition of written digits. To this aim, deep networks trained on Persian letters were used to build high-level representations of Persian digits, which were indeed read out with high accuracy. Our simulations show that complex visual features, such as those mediating the identification of Persian symbols, can emerge from unsupervised learning in multilayered neural networks and can support knowledge transfer across related domains.

Penalized unsupervised learning with outliers

PubMed Central

Witten, Daniela M.

2013-01-01

We consider the problem of performing unsupervised learning in the presence of outliers – that is, observations that do not come from the same distribution as the rest of the data. It is known that in this setting, standard approaches for unsupervised learning can yield unsatisfactory results. For instance, in the presence of severe outliers, K-means clustering will often assign each outlier to its own cluster, or alternatively may yield distorted clusters in order to accommodate the outliers. In this paper, we take a new approach to extending existing unsupervised learning techniques to accommodate outliers. Our approach is an extension of a recent proposal for outlier detection in the regression setting. We allow each observation to take on an “error” term, and we penalize the errors using a group lasso penalty in order to encourage most of the observations’ errors to exactly equal zero. We show that this approach can be used in order to develop extensions of K-means clustering and principal components analysis that result in accurate outlier detection, as well as improved performance in the presence of outliers. These methods are illustrated in a simulation study and on two gene expression data sets, and connections with M-estimation are explored. PMID:23875057

A Comparative Evaluation of Unsupervised Anomaly Detection Algorithms for Multivariate Data.

PubMed

Goldstein, Markus; Uchida, Seiichi

2016-01-01

Anomaly detection is the process of identifying unexpected items or events in datasets, which differ from the norm. In contrast to standard classification tasks, anomaly detection is often applied on unlabeled data, taking only the internal structure of the dataset into account. This challenge is known as unsupervised anomaly detection and is addressed in many practical applications, for example in network intrusion detection, fraud detection as well as in the life science and medical domain. Dozens of algorithms have been proposed in this area, but unfortunately the research community still lacks a comparative universal evaluation as well as common publicly available datasets. These shortcomings are addressed in this study, where 19 different unsupervised anomaly detection algorithms are evaluated on 10 different datasets from multiple application domains. By publishing the source code and the datasets, this paper aims to be a new well-funded basis for unsupervised anomaly detection research. Additionally, this evaluation reveals the strengths and weaknesses of the different approaches for the first time. Besides the anomaly detection performance, computational effort, the impact of parameter settings as well as the global/local anomaly detection behavior is outlined. As a conclusion, we give an advise on algorithm selection for typical real-world tasks.

Unsupervised categorization with individuals diagnosed as having moderate traumatic brain injury: Over-selective responding.

PubMed

Edwards, Darren J; Wood, Rodger

2016-01-01

This study explored over-selectivity (executive dysfunction) using a standard unsupervised categorization task. Over-selectivity has been demonstrated using supervised categorization procedures (where training is given); however, little has been done in the way of unsupervised categorization (without training). A standard unsupervised categorization task was used to assess levels of over-selectivity in a traumatic brain injury (TBI) population. Individuals with TBI were selected from the Tertiary Traumatic Brain Injury Clinic at Swansea University and were asked to categorize two-dimensional items (pictures on cards), into groups that they felt were most intuitive, and without any learning (feedback from experimenter). This was compared against categories made by a control group for the same task. The findings of this study demonstrate that individuals with TBI had deficits for both easy and difficult categorization sets, as indicated by a larger amount of one-dimensional sorting compared to control participants. Deficits were significantly greater for the easy condition. The implications of these findings are discussed in the context of over-selectivity, and the processes that underlie this deficit. Also, the implications for using this procedure as a screening measure for over-selectivity in TBI are discussed.

Accuracy of latent-variable estimation in Bayesian semi-supervised learning.

PubMed

Yamazaki, Keisuke

2015-09-01

Hierarchical probabilistic models, such as Gaussian mixture models, are widely used for unsupervised learning tasks. These models consist of observable and latent variables, which represent the observable data and the underlying data-generation process, respectively. Unsupervised learning tasks, such as cluster analysis, are regarded as estimations of latent variables based on the observable ones. The estimation of latent variables in semi-supervised learning, where some labels are observed, will be more precise than that in unsupervised, and one of the concerns is to clarify the effect of the labeled data. However, there has not been sufficient theoretical analysis of the accuracy of the estimation of latent variables. In a previous study, a distribution-based error function was formulated, and its asymptotic form was calculated for unsupervised learning with generative models. It has been shown that, for the estimation of latent variables, the Bayes method is more accurate than the maximum-likelihood method. The present paper reveals the asymptotic forms of the error function in Bayesian semi-supervised learning for both discriminative and generative models. The results show that the generative model, which uses all of the given data, performs better when the model is well specified. Copyright © 2015 Elsevier Ltd. All rights reserved.

Segmentation of fluorescence microscopy cell images using unsupervised mining.

PubMed

Du, Xian; Dua, Sumeet

2010-05-28

The accurate measurement of cell and nuclei contours are critical for the sensitive and specific detection of changes in normal cells in several medical informatics disciplines. Within microscopy, this task is facilitated using fluorescence cell stains, and segmentation is often the first step in such approaches. Due to the complex nature of cell issues and problems inherent to microscopy, unsupervised mining approaches of clustering can be incorporated in the segmentation of cells. In this study, we have developed and evaluated the performance of multiple unsupervised data mining techniques in cell image segmentation. We adapt four distinctive, yet complementary, methods for unsupervised learning, including those based on k-means clustering, EM, Otsu's threshold, and GMAC. Validation measures are defined, and the performance of the techniques is evaluated both quantitatively and qualitatively using synthetic and recently published real data. Experimental results demonstrate that k-means, Otsu's threshold, and GMAC perform similarly, and have more precise segmentation results than EM. We report that EM has higher recall values and lower precision results from under-segmentation due to its Gaussian model assumption. We also demonstrate that these methods need spatial information to segment complex real cell images with a high degree of efficacy, as expected in many medical informatics applications.

Effects of Supervised vs. Unsupervised Training Programs on Balance and Muscle Strength in Older Adults: A Systematic Review and Meta-Analysis.

PubMed

Lacroix, André; Hortobágyi, Tibor; Beurskens, Rainer; Granacher, Urs

2017-11-01

Balance and resistance training can improve healthy older adults' balance and muscle strength. Delivering such exercise programs at home without supervision may facilitate participation for older adults because they do not have to leave their homes. To date, no systematic literature analysis has been conducted to determine if supervision affects the effectiveness of these programs to improve healthy older adults' balance and muscle strength/power. The objective of this systematic review and meta-analysis was to quantify the effectiveness of supervised vs. unsupervised balance and/or resistance training programs on measures of balance and muscle strength/power in healthy older adults. In addition, the impact of supervision on training-induced adaptive processes was evaluated in the form of dose-response relationships by analyzing randomized controlled trials that compared supervised with unsupervised trials. A computerized systematic literature search was performed in the electronic databases PubMed, Web of Science, and SportDiscus to detect articles examining the role of supervision in balance and/or resistance training in older adults. The initially identified 6041 articles were systematically screened. Studies were included if they examined balance and/or resistance training in adults aged ≥65 years with no relevant diseases and registered at least one behavioral balance (e.g., time during single leg stance) and/or muscle strength/power outcome (e.g., time for 5-Times-Chair-Rise-Test). Finally, 11 studies were eligible for inclusion in this meta-analysis. Weighted mean standardized mean differences between subjects (SMD bs ) of supervised vs. unsupervised balance/resistance training studies were calculated. The included studies were coded for the following variables: number of participants, sex, age, number and type of interventions, type of balance/strength tests, and change (%) from pre- to post-intervention values. Additionally, we coded training according to the following modalities: period, frequency, volume, modalities of supervision (i.e., number of supervised/unsupervised sessions within the supervised or unsupervised training groups, respectively). Heterogeneity was computed using I 2 and χ 2 statistics. The methodological quality of the included studies was evaluated using the Physiotherapy Evidence Database scale. Our analyses revealed that in older adults, supervised balance/resistance training was superior compared with unsupervised balance/resistance training in improving measures of static steady-state balance (mean SMD bs  = 0.28, p = 0.39), dynamic steady-state balance (mean SMD bs  = 0.35, p = 0.02), proactive balance (mean SMD bs  = 0.24, p = 0.05), balance test batteries (mean SMD bs  = 0.53, p = 0.02), and measures of muscle strength/power (mean SMD bs  = 0.51, p = 0.04). Regarding the examined dose-response relationships, our analyses showed that a number of 10-29 additional supervised sessions in the supervised training groups compared with the unsupervised training groups resulted in the largest effects for static steady-state balance (mean SMD bs  = 0.35), dynamic steady-state balance (mean SMD bs  = 0.37), and muscle strength/power (mean SMD bs  = 1.12). Further, ≥30 additional supervised sessions in the supervised training groups were needed to produce the largest effects on proactive balance (mean SMD bs  = 0.30) and balance test batteries (mean SMD bs  = 0.77). Effects in favor of supervised programs were larger for studies that did not include any supervised sessions in their unsupervised programs (mean SMD bs : 0.28-1.24) compared with studies that implemented a few supervised sessions in their unsupervised programs (e.g., three supervised sessions throughout the entire intervention program; SMD bs : -0.06 to 0.41). The present findings have to be interpreted with caution because of the low number of eligible studies and the moderate methodological quality of the included studies, which is indicated by a median Physiotherapy Evidence Database scale score of 5. Furthermore, we indirectly compared dose-response relationships across studies and not from single controlled studies. Our analyses suggest that supervised balance and/or resistance training improved measures of balance and muscle strength/power to a greater extent than unsupervised programs in older adults. Owing to the small number of available studies, we were unable to establish a clear dose-response relationship with regard to the impact of supervision. However, the positive effects of supervised training are particularly prominent when compared with completely unsupervised training programs. It is therefore recommended to include supervised sessions (i.e., two out of three sessions/week) in balance/resistance training programs to effectively improve balance and muscle strength/power in older adults.

Examining unsupervised time with peers and the role of association with delinquent peers on adolescent smoking.

PubMed

Greene, Kathryn; Banerjee, Smita C

2009-04-01

This study explored the association between unsupervised time with peers and adolescent smoking behavior both directly and indirectly through interaction with delinquent peers, social expectancies about cigarette smoking, and cigarette offers from peers. A cross-sectional survey was used for the study and included 248 male and female middle school students. Results of structural equation modeling revealed that unsupervised time with peers is associated indirectly with adolescent smoking behavior through the mediation of association with delinquent peers, social expectancies about cigarette smoking, and cigarette offers from peers. Interventions designed to motivate adolescents without adult supervision to associate more with friends who engage in prosocial activities may eventually reduce adolescent smoking. Further implications for structured supervised time for students outside of school time are discussed.

A comparison of neural network and fuzzy clustering techniques in segmenting magnetic resonance images of the brain

NASA Technical Reports Server (NTRS)

Hall, Lawrence O.; Bensaid, Amine M.; Clarke, Laurence P.; Velthuizen, Robert P.; Silbiger, Martin S.; Bezdek, James C.

1992-01-01

Magnetic resonance (MR) brain section images are segmented and then synthetically colored to give visual representations of the original data with three approaches: the literal and approximate fuzzy c-means unsupervised clustering algorithms and a supervised computational neural network, a dynamic multilayered perception trained with the cascade correlation learning algorithm. Initial clinical results are presented on both normal volunteers and selected patients with brain tumors surrounded by edema. Supervised and unsupervised segmentation techniques provide broadly similar results. Unsupervised fuzzy algorithms were visually observed to show better segmentation when compared with raw image data for volunteer studies. However, for a more complex segmentation problem with tumor/edema or cerebrospinal fluid boundary, where the tissues have similar MR relaxation behavior, inconsistency in rating among experts was observed.

75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0434] Draft Guidance for Industry: Acidified Foods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft...

75 FR 53975 - Office of Women's Health Update

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Office of Women's Health Update AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration (FDA) is announcing the following meeting: Office of Women's Health (OWH...

21 CFR 1316.05 - Entry.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Entry. 1316.05 Section 1316.05 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.05 Entry. An inspection shall be carried out by an inspector. Any such...

21 CFR 1316.46 - Inspection of record.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Inspection of record. 1316.46 Section 1316.46 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.46 Inspection of record. (a) The record bearing on any...

21 CFR 1316.65 - Report and record.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Report and record. 1316.65 Section 1316.65 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.65 Report and record. (a) As soon as practicable after...

21 CFR 1316.01 - Scope of subpart A.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Scope of subpart A. 1316.01 Section 1316.01 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.01 Scope of subpart A. Procedures regarding...

21 CFR 1316.48 - Notice of appearance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Notice of appearance. 1316.48 Section 1316.48 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.48 Notice of appearance. Any person entitled to a...

21 CFR 1316.67 - Final order.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Final order. 1316.67 Section 1316.67 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.67 Final order. As soon as practicable after the presiding officer...

21 CFR 1316.49 - Waiver of hearing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Waiver of hearing. 1316.49 Section 1316.49 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.49 Waiver of hearing. Any person entitled to a hearing...

78 FR 42451 - Animal Feeds Contaminated With Salmonella Microorganisms

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 500 [Docket No. FDA-2013-N-0253] Animal Feeds Contaminated With Salmonella Microorganisms AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; removal. SUMMARY: The Food and Drug Administration (FDA or Agency) is...

21 CFR 880.5440 - Intravascular administration set.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Intravascular administration set. 880.5440 Section 880.5440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...

75 FR 60768 - Single-Ingredient Oral Colchicine Products; Enforcement Action Dates

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0257] Single-Ingredient Oral Colchicine Products; Enforcement Action Dates AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or agency) is announcing its...

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...

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

77 FR 27072 - Gastrointestinal Drugs Advisory Committee; Cancellation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastrointestinal Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Gastrointestinal Drugs Advisory Committee scheduled for May 31, 2012, is...

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

75 FR 81283 - Oncologic Drugs Advisory Committee; Cancellation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee scheduled for February 9, 2011, is...

28 CFR 83.625 - Criminal drug statute.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Criminal drug statute. 83.625 Section 83.625 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) GOVERNMENT-WIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (GRANTS) Definitions § 83.625 Criminal drug statute. Criminal drug statute means a...

75 FR 5333 - Endocrinologic and Metabolic Drugs Advisory Committee; Cancellation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Endocrinologic and Metabolic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Endocrinologic and Metabolic Drugs Advisory Committee...

28 CFR 83.625 - Criminal drug statute.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Criminal drug statute. 83.625 Section 83.625 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) GOVERNMENT-WIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (GRANTS) Definitions § 83.625 Criminal drug statute. Criminal drug statute means a...

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

28 CFR 83.625 - Criminal drug statute.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Criminal drug statute. 83.625 Section 83.625 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) GOVERNMENT-WIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (GRANTS) Definitions § 83.625 Criminal drug statute. Criminal drug statute means a...

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

28 CFR 83.625 - Criminal drug statute.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Criminal drug statute. 83.625 Section 83.625 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) GOVERNMENT-WIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (GRANTS) Definitions § 83.625 Criminal drug statute. Criminal drug statute means a...

75 FR 36101 - Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee...

77 FR 63839 - Oncologic Drugs Advisory Committee; Cancellation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee Meeting scheduled for November 8, 2012, is...

28 CFR 83.625 - Criminal drug statute.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Criminal drug statute. 83.625 Section 83.625 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) GOVERNMENT-WIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (GRANTS) Definitions § 83.625 Criminal drug statute. Criminal drug statute means a...

28 CFR 0.101 - Specific functions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Specific functions. 0.101 Section 0.101 Judicial Administration DEPARTMENT OF JUSTICE ORGANIZATION OF THE DEPARTMENT OF JUSTICE Drug Enforcement Administration § 0.101 Specific functions. The Administrator of the Drug Enforcement Administration shall be...

21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

.... These guidelines are on file in the Dockets Management Branch (HFA-305), Food and Drug Administration... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

76 FR 79064 - New Animal Drugs; Change of Sponsor; Zinc Gluconate

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

... [Docket No. FDA-2011-N-0003] New Animal Drugs; Change of Sponsor; Zinc Gluconate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for zinc...

75 FR 34361 - New Animal Drugs for Use in Animal Feeds; Florfenicol

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

.... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Florfenicol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

76 FR 79064 - New Animal Drugs for Use in Animal Feeds; Monensin

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

.... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Monensin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

77 FR 4228 - New Animal Drugs for Use in Animal Feeds; Monensin

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-27

.... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Monensin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

75 FR 5887 - New Animal Drugs for Use in Animal Feeds; Ractopamine; Monensin

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

.... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Ractopamine; Monensin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Elanco...

75 FR 54019 - New Animal Drugs for Use in Animal Feed; Ractopamine

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-03

.... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feed; Ractopamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by...

77 FR 22667 - New Animal Drugs for Use in Animal Feeds; Tiamulin

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-17

.... FDA-2012-N-0002] New Animal Drugs for Use in Animal Feeds; Tiamulin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application...

76 FR 40229 - Oral Dosage Form New Animal Drugs; Change of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-08

.... FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Virbac AH...

75 FR 9334 - New Animal Drugs for Use in Animal Feeds; Chlortetracycline

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-02

.... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Chlortetracycline AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by ADM...

77 FR 24138 - New Animal Drugs for Use in Animal Feeds; Tiamulin

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-23

.... FDA-2012-N-0002] New Animal Drugs for Use in Animal Feeds; Tiamulin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

75 FR 54018 - Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-03

.... FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...