Science.gov

Sample records for efficacy supplement approvals

  1. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review

    PubMed Central

    Wang, Bo

    2015-01-01

    Objective To characterize the types of comparators and endpoints used in efficacy trials for approvals of supplemental indications, compared with the data supporting these drugs’ originally approved indications. Design Systematic review. Setting Publicly accessible data on supplemental indications approved by the US Food and Drug Administration from 2005 to 2014. Main outcome measures Types of comparators (active, placebo, historical, none) and endpoints (clinical outcomes, clinical scales, surrogate) in the efficacy trials for these drugs’ supplemental and original indication approvals. Results The cohort included 295 supplemental indications. Thirty per cent (41/136) of supplemental approvals for new indications were supported by efficacy trials with active comparators, compared with 51% (47/93) of modified use approvals and 11% (7/65) of approvals expanding the patient population (P<0.001), almost all of which related to pediatric patients (61/65; 94%). Trials using clinical outcome endpoints led to approval for 32% (44/137) of supplemental approvals for new indications, 30% (28/93) of modified indication approvals, and 22% (14/65) of expanded population approvals (P=0.29). Orphan drugs had supplemental approvals for 40 non-orphan indications, which were supported by similar proportions of trials using active comparators (28% (11/40) for non-orphan supplemental indications versus 24% (10/42) for original orphan indications; P=0.70) and clinical outcome endpoints (25% (10/40) versus 31% (13/42); P=0.55). Conclusions Wide variations were seen in the evidence supporting approval of supplemental indications, with the fewest active comparators and clinical outcome endpoints used in trials leading to supplemental approvals that expanded the patient population. PMID:26400844

  2. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Approval of supplemental applications. 514.106 Section 514.106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUG APPLICATIONS Administrative Actions on Applications § 514.106 Approval...

  3. Supplements and other changes to an approved application. Final rule.

    PubMed

    2004-04-01

    The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report. PMID:15072041

  4. FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012

    PubMed Central

    Rome, Benjamin N.; Kramer, Daniel B.; Kesselheim, Aaron S.

    2014-01-01

    IMPORTANCE The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via “supplements,” which may not require additional clinical testing. OBJECTIVE To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. DESIGN Using the FDA’s PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories overtime. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. RESULTS From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device’s design. Among 180-day supplements approved from 2010

  5. 29 CFR 1953.6 - Review and approval of plan supplements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Review and approval of plan supplements. 1953.6 Section 1953.6 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) CHANGES TO STATE PLANS § 1953.6 Review and approval of plan supplements....

  6. 21 CFR 314.71 - Procedures for submission of a supplement to an approved application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Procedures for submission of a supplement to an approved application. 314.71 Section 314.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DRUG Applications § 314.71 Procedures for submission of a supplement to an approved application....

  7. 29 CFR 1953.6 - Review and approval of plan supplements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 9 2011-07-01 2011-07-01 false Review and approval of plan supplements. 1953.6 Section 1953.6 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) CHANGES TO STATE PLANS § 1953.6 Review and approval of plan supplements....

  8. 78 FR 65219 - Defense Federal Acquisition Regulation Supplement: Approval of Rental Waiver Requests (DFARS Case...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-31

    ... Regulation Supplement: Approval of Rental Waiver Requests (DFARS Case 2013-D006) AGENCY: Defense Acquisition... officers to approve requests for waiver or reduction of rental charges for the use of Government property... extremely low dollar values over the rental period. Currently, DSCA is required to approve requests in...

  9. 76 FR 20435 - Notice of Approval of the Supplemental Finding of No Significant Impact and Record of Decision...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-12

    ... Supplemental Finding ] of No Significant Impact/Record of Decision (FONSI/ROD) for the Supplemental.... The Supplemental FONSI/ROD provides final agency determinations and approvals for the proposed...). SUPPLEMENTARY INFORMATION: The Supplemental FONSI/ROD is for the approval of actions for proposed changes to...

  10. Efficacy and Safety of Saffron Supplementation: Current Clinical Findings.

    PubMed

    Broadhead, G K; Chang, A; Grigg, J; McCluskey, P

    2016-12-01

    Saffron (Crocus savitus) is a Middle-Eastern herb with strong antioxidant properties. Its major constituents, safranal, crocin, and crocetin, are also antioxidants and bear structural similarities to other well-known natural antixodant substances, such as zeaxanthin. Given the role of oxidative stress in many diseases, considerable interest has been shown into the potential role of saffron supplementation as a treatment for a range of diseases. In vitro and animal studies have provided evidence that saffron and its constituents may be potent therapies for a range of pathologies, including Alzheimer's disease, age-related macular degeneration (AMD) and cardiac ischemia. Whether these findings translate into clinical efficacy, however, has as of yet been incompletely assessed. This makes assessing the role of saffron supplementation in these diseases difficult. Here, we review the current human clinical evidence supporting saffron supplementation as a treatment for a range of pathologies and the underlying science supporting its use. PMID:25875654

  11. 21 CFR 314.97 - Supplements and other changes to an approved abbreviated application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Supplements and other changes to an approved abbreviated application. 314.97 Section 314.97 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A...

  12. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... approved standards. (x) A change in an expiration date. (xi) Addition of an alternate...

  13. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... approved standards. (x) A change in an expiration date. (xi) Addition of an alternate...

  14. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... approved standards. (x) A change in an expiration date. (xi) Addition of an alternate...

  15. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... approved standards. (x) A change in an expiration date. (xi) Addition of an alternate...

  16. Analysis of Selection Activities to Supplement Approval Plans.

    ERIC Educational Resources Information Center

    Loup, Jean L.; Snoke, Helen Lloyd

    1991-01-01

    Describes two surveys of libraries by the Association of Research Libraries (ARL) that were conducted to compare approval plans and to determine alternative acquisitions methods for materials in philosophy and political science. Time spent by selectors is examined, collection evaluation activities are described, and implications for resource…

  17. 78 FR 11808 - Approval and Promulgation of Implementation Plans; Tennessee: Approve Knox County Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... revised ozone National Ambient Air Quality Standards (NAAQS). See 73 FR 16436. The current action, however... Supplemental Motor Vehicle Emissions Budget Update AGENCY: Environmental Protection Agency (EPA). ACTION... revision proposes to increase the safety margin allocated to motor vehicle emissions budgets for...

  18. 78 FR 46977 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ...The Food and Drug Administration (FDA) is announcing the rate for the abbreviated new drug application (ANDA), prior approval supplement to an approved ANDA (PAS), drug master file (DMF), generic drug active pharmaceutical ingredient (API), and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2014. The Federal Food, Drug, and......

  19. Efficacy comparison of medications approved for chronic weight management.

    PubMed

    Kumar, Rekha B; Aronne, Louis J

    2015-04-01

    For the first time, patients who are obese are able to benefit from 5 different FDA approved pharmacologic agents for chronic weight management. Although weight loss from all of these medications was limited to 5% to 10% of total body weight loss in the Phase III clinical trials, patients are capable of losing more weight when a cumulative approach of diet, exercise, and multiple medications are used. A pilot study of adding phentermine to lorcaserin yielded double the weight loss than lorcaserin alone. A higher percentage of total body weight is lost with use of combination phentermine/topiramate compared to orlistat, lorcaserin, and bupropion/naltrexone but there are more contraindications to its use and potential cardiovascular adverse effects due to adrenergic agonism. Lorcaserin and bupropion/naltrexone yielded similar weight loss but carry different adverse effect profiles and interactions with other psychiatric medications may preclude use of one over the other. When choosing a medication for obesity, several factors need to be considered, such as comorbidities, medication interactions, and risk of potential adverse effects. PMID:25900871

  20. Safety, Efficacy, and Legal Issues Related to Dietary Supplements

    ERIC Educational Resources Information Center

    Powers, Michael

    2004-01-01

    This article focuses on the effects of dietary supplements on collegiate and adult populations. Anabolic steroids, amphetamines, and other drugs have been used for decades to improve athletic performance. However, the legal issues and dangers associated with these drugs have resulted in reluctance by many athletes to use them. Because dietary…

  1. 30 CFR 250.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... of production or storage capacity; (4) Increase the emissions of an air pollutant to an amount that... 30 Mineral Resources 2 2011-07-01 2011-07-01 false When must I revise or supplement the approved EP, DPP, or DOCD? 250.283 Section 250.283 Mineral Resources BUREAU OF OCEAN ENERGY...

  2. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? 111.525 Section 111.525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR...

  3. Efficacy of a Botanical Supplement with Concentrated Echinacea purpurea for Increasing Aerobic Capacity

    PubMed Central

    Bellar, David; Moody, Kaitlyn M.; Richard, Nicholas S.; Judge, Lawrence W.

    2014-01-01

    The present investigation evaluated the efficacy of a botanical supplement that delivered a concentrated dose of Echinacea purpurea (8 grams day−1). The participants were 13 apparently healthy, recreationally active college students (VO2 max: 51 mL O2/kg∗min). The participants were provided with a 30-day supplementation regime. Data regarding maximum aerobic capacity was collected through pre- and posttesting surrounding the 30-day supplementation regime. The participants were instructed to maintain normal levels of physical activity and exercise during the experimental period. The levels of physical activity and exercise were monitored via the Leisure and Physical Activity Survey. The participants did not report any significant increases in aerobic physical activity or exercise during the supplementation period. Paired samples t-test analysis did not reveal a significant difference in maximum aerobic capacity, t(12) = 0.67, P = .516. Presupplementation maximum aerobic capacity (M = 51.0, SD = 6.8) was similar to postsupplementation values (M = 51.8, SD = 6.5). This study suggests that botanical supplements containing a concentrated dose of Echinacea purpurea is not an effective intervention to increase aerobic capacity of recreationally active individuals. PMID:24967264

  4. Efficacy of dietary aloe vera supplementation on hepatic cholesterol and oxidative status in aged rats.

    PubMed

    Lim, Beong Ou; Seong, Nak Sul; Choue, Ryo Won; Kim, Jong Dai; Lee, Hyeon Yong; Kim, Sun Yeou; Yu, Byung Pal; Jeon, Tae Il; Park, Dong Ki

    2003-08-01

    In the current study, we show the anti-oxidative and hypocholesterol effects of aloe vera in the liver. Male specific pathogen-free (SPF) Fischer 344 rats were randomly assigned to one of four groups: Group A (control) was fed test chow without aloe supplementation; Group B was fed a diet containing a 1% (per weight basis) freeze-dried aloe filet; Group C was fed a diet containing a 1% (per weight basis) charcoal-processed, freeze-dried aloe filet; and Group D was fed a diet containing a charcoal-processed freeze-dried, whole leaf aloe (0.02% per weight basis) in the drinking water. Our results show that a life-long intake of aloe had superior anti-oxidative action against lipid peroxidation in vivo, as indicated by reduced levels of hepatic phosphatidylcholine hydroperoxide. Additional anti-oxidative action was evidenced by enhanced superoxide dismutase (SOD) and catalase activity in groups B and C. Furthermore, our study revealed that hepatic cholesterol significantly increased in the control group during aging in contrast to the aloe-supplemented groups, which showed approximately 30% lower cholesterol levels, thereby an effective hypocholesteremic efficacy. In this report, we suggest that life-long dietary aloe supplementation suppresses free radical-induced oxidative damage and age-related increases in hepatic cholesterol. PMID:14598919

  5. Efficacy of Vitamin C Supplements in Prevention of Cancer: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Lee, Bobae; Oh, Seung-Won

    2015-01-01

    Background Previous randomized controlled trials (RCTs) have reported inconsistent findings regarding the association between vitamin C supplementation and the risk of cancer. Methods We performed a meta-analysis of RCTs to investigate the efficacy of vitamin C supplements for prevention of cancer. We searched the PubMed, EMBASE, and Cochrane Library databases in November 2014 using common keywords related to vitamin C supplements and cancer. Results Among 785 articles, a total of seven trials were identified, which included 62,619 participants; 31,326 and 31,293 were randomized to vitamin C supplementation and control or placebo groups, respectively, which were included in the final analysis. A fixed-effects meta-analysis of all seven RCTs revealed no significant association between vitamin C supplementation and cancer (relative risk, 1.00; 95% confidence intervals, 0.95-1.05). Similarly, subgroup meta-analysis by dose of vitamin C administered singly or in combination with other supplements, follow-up period, methodological quality, cancer mortality, gender, smoking status, country, and type of cancer also showed no efficacy of vitamin C supplementation for cancer prevention. Conclusion This meta-analysis shows that there is no evidence to support the use of vitamin C supplements for prevention of cancer. PMID:26634093

  6. Expectancy, self-efficacy, and placebo effect of a sham supplement for weight loss in obese subjects

    PubMed Central

    Tippens, Kimberly M; Purnell, Jonathan Q; Gregory, William L; Connelly, Erin; Hanes, Douglas; Oken, Barry; Calabrese, Carlo

    2014-01-01

    This study examined the role of expectancy in the placebo effect of a sham dietary supplement for weight loss in 114 obese adults. All participants received lifestyle education and were randomized to one of three conditions: 1) a daily placebo capsule and told that they were taking an active weight loss supplement; 2) daily placebo and told they had a 50% random chance of receiving either the active or placebo; or 3) no capsules. At 12 weeks, weight loss and metabolic outcomes were similar among the three groups. Participants in both groups that took capsules showed decreased weight loss self-efficacy and increased expectations of benefit from dietary supplements. Participants not taking capsules showed the opposite. Adverse events were more frequently reported in groups taking capsules than those who were not. These findings suggest that supplements without weight loss effects may have nocebo effects through diminished self-efficacy. PMID:24695007

  7. Efficacy of Vitamin and Antioxidant Supplements in Prevention of Esophageal Cancer: Meta-analysis of Randomized Controlled Trials

    PubMed Central

    Myung, Seung-Kwon; Yang, Hyo Jin

    2013-01-01

    Background: Observational epidemiological studies have shown that higher intakes of vitamins or antioxidants were inversely associated with the risk of esophageal cancer. However, randomized controlled trials (RCTs) have reported no preventive efficacy of vitamin or antioxidant supplements on esophageal cancer. This meta-analysis aimed to investigate the efficacy of vitamin and antioxidant supplements in the prevention of esophageal cancer as reported by RCTs. Methods: We searched PubMed, EMBASE, and the Cochrane Library in May 2013. Two authors independently reviewed and selected eligible articles based on predetermined selection criteria. Results: Of 171 articles searched from three databases and relevant bibliographies, 10 RCTs were included in the final analyses. In a fixed-effect meta-analysis of 10 trials, there was no efficacy of vitamin and antioxidant supplements in the prevention of esophageal cancer (relative risk [RR], 1.04; 95% confidence interval [CI], 0.86–1.25; I2=0.0%). Also, subgroup meta-analyses showed that vitamin and antioxidant supplements had no preventive efficacy on esophageal cancer both in the high risk (RR, 1.04; 95% CI, 0.85–1.28; n=4) and non-high risk (RR, 1.01; 95% CI, 0.65–1.56; n=6) groups for esophageal cancer. Further, subgroup meta-analyses revealed no preventive efficacy on esophageal cancer by type of methodological quality and type of vitamin and antioxidant supplements. Conclusions: Unlike observational epidemiological studies, this meta-analysis of RCTs suggests that there is no clinical evidence to support the efficacy of vitamin and antioxidant supplements in the prevention of esophageal cancer. PMID:25337539

  8. 78 FR 11754 - Approval and Promulgation of Implementation Plans; Tennessee: Knox County Supplement Motor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... December 18, 2012, (77 FR 74820), EPA proposed to approve through parallel processing Tennessee's October... nonattainment for the 1-hour ozone national ambient air quality standards (NAAQS) on November 6, 1991 (56 FR... (58 FR 50271). In this approval, was a 10-year air quality maintenance plan covering the years...

  9. Efficacy of Medications Approved for the Treatment of Alcohol Dependence and Alcohol Withdrawal Syndrome in Female Patients: A Descriptive Review.

    PubMed

    Agabio, Roberta; Pani, Pier Paolo; Preti, Antonio; Gessa, Gian Luigi; Franconi, Flavia

    2016-01-01

    The aim of this study was to evaluate whether the number of women recruited for studies to establish the efficacy of medications approved for treatment of alcohol dependence (AD) and of alcohol withdrawal syndrome (AWS) is sufficient to reveal possible gender differences in the response to these medications and in suggesting the use of different doses in female patients. Our results show that the rates of women recruited for studies evaluating the efficacy of disulfiram (1%), benzodiazepines (3%), and anticonvulsants (13%) were too low to establish possible gender differences. The rates of women recruited for studies evaluating the efficacy of acamprosate (22%), naltrexone (23%), and nalmefene (30%) were higher and allowed evaluation of data obtained for female patients. Women receive medications for treatment of AD and/or AWS for which efficacy has been demonstrated in studies in which men were more largely represented. PMID:26314552

  10. Efficacy of an oral hyaluronate and collagen supplement as a preventive treatment of elbow dysplasia.

    PubMed

    Martí-Angulo, Simón; García-López, Núria; Díaz-Ramos, Ana

    2014-12-01

    One hundred and five Labrador dogs were randomly divided into two groups to determine the number of animals that develop elbow dysplasia when treated with an oral supplement compared to untreated ones. Efficacy of the oral treatment was also evaluated once illness was diagnosed. The supplement (Hyaloral) contained hyaluronic acid, hydrolysed collagen, glucosamine, chondroitin sulphate, and gamma oryzanol. Clinical evaluation of the elbow joints was completed at months 3, 6, 12, and 20 by orthopaedic evaluations, radiography, serologic and blood analysis, and veterinarian evaluation of dysplasia symptoms. All side effects were recorded. In the control group, 33.3% of the dogs developed radiographic evidence of elbow dysplasia compared to 18.5% in the treated group. Symptoms of dysplasia at 12 months differed between the treated (12.5%) and control (61.5%) animals, and were significantly different at 20 months (p < 0.05). Differences in lameness along with movement and swelling of the elbows between groups were observed after 12 months. The treated group had improved significantly by the last visit (p < 0.05). No adverse side effects were reported. In conclusion, oral treatment with Hyaloral may have a potential cumulative action that provides protection against dysplasia and significantly improves symptoms of elbow dysplasia. PMID:25234322

  11. Efficacy of an oral hyaluronate and collagen supplement as a preventive treatment of elbow dysplasia

    PubMed Central

    García-López, Núria; Díaz-Ramos, Ana

    2014-01-01

    One hundred and five Labrador dogs were randomly divided into two groups to determine the number of animals that develop elbow dysplasia when treated with an oral supplement compared to untreated ones. Efficacy of the oral treatment was also evaluated once illness was diagnosed. The supplement (Hyaloral) contained hyaluronic acid, hydrolysed collagen, glucosamine, chondroitin sulphate, and gamma oryzanol. Clinical evaluation of the elbow joints was completed at months 3, 6, 12, and 20 by orthopaedic evaluations, radiography, serologic and blood analysis, and veterinarian evaluation of dysplasia symptoms. All side effects were recorded. In the control group, 33.3% of the dogs developed radiographic evidence of elbow dysplasia compared to 18.5% in the treated group. Symptoms of dysplasia at 12 months differed between the treated (12.5%) and control (61.5%) animals, and were significantly different at 20 months (p < 0.05). Differences in lameness along with movement and swelling of the elbows between groups were observed after 12 months. The treated group had improved significantly by the last visit (p < 0.05). No adverse side effects were reported. In conclusion, oral treatment with Hyaloral may have a potential cumulative action that provides protection against dysplasia and significantly improves symptoms of elbow dysplasia. PMID:25234322

  12. The Efficacy of Supplemental Early Literacy Instruction by Community-Based Tutors for Preschoolers Enrolled in Head Start

    ERIC Educational Resources Information Center

    Nelson, J. Ron; Sanders, Elizabeth A.; Gonzalez, Jorge

    2010-01-01

    The purpose of the current study was to test the efficacy of a supplemental phonological awareness focused intervention delivered by community-based paraeducators with preschool children (M = 4.73 years) in eight Head Start classrooms in the rural Midwest. Participating children were randomly assigned to small groups within classrooms, which were…

  13. Efficacy of a Tier 2 Supplemental Root Word Vocabulary and Decoding Intervention with Kindergarten Spanish-Speaking English Learners

    ERIC Educational Resources Information Center

    Nelson, J. Ron; Vadasy, Patricia F.; Sanders, Elizabeth A.

    2011-01-01

    The purpose of this study was to test the efficacy of a Tier 2 standard protocol supplemental intervention designed simultaneously to develop root word vocabulary and reinforce decoding skills being taught to all students in the core beginning reading program with kindergarten Spanish-speaking English learners (ELs). Participating students were…

  14. 75 FR 78779 - Order Approving Public Company Accounting Oversight Board Supplemental Budget Request To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... December 22, 2009.\\3\\ \\2\\ 17 CFR 202.190. See Release No. 33-8724 (July 18, 2006) [71 FR 41998 (July 24... Release No. 63526/December 10, 2010] Order Approving Public Company Accounting Oversight Board...-Oxley Act of 2002 \\1\\ (the ``Sarbanes-Oxley Act'') established the Public Company Accounting...

  15. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... solely affecting a natural product, a recombinant DNA-derived protein/polypeptide, or a complex or...) or references to previously approved documentation; (H) For a natural product, a recombinant DNA... this section; (B) Changes solely affecting a natural protein, a recombinant DNA-derived...

  16. Efficacy of dietary supplementation with botanicals on carbohydrate metabolism in humans.

    PubMed

    Cefalu, William T; Ye, Jianping; Wang, Zhong Q

    2008-06-01

    Botanical products are widely used in nutritional supplementation for promotion of health or prevention of diseases. With the high prevalence of obesity and type 2 diabetes, abnormalities in carbohydrate metabolism are common in the general population and obtaining glycemic control is important in reducing the complications of diabetes. If shown to be effective, botanical products have a unique position in potentially aiding the general public in regard to obesity and diabetes. They can be obtained "over-the-counter" and may have less side effects compared to many synthetic drugs. Although most of the popular botanicals have a long history in folk medicine, there is paucity of data regarding their efficacy and safety, particularly as it relates to human studies. In this review, we discuss the data that was available in the literature for nine botanicals that are frequently promoted to help manage blood glucose. They are Bitter Melon (Momordica charantia), Fenugreek (trigonella foenum graecum), Gymnema Sylvestre, Ivy Gourd (Coccinia indica), Nopal or Prickly Pear Cactus (Opuntia streptacantha), Ginseng, Aloe Vera, Russian Tarragon (Artemisia dracunculus), and Garlic (Allium sativum). The discussion is emphasized on the clinical aspect of these botanicals. Due to the lack of sufficient evidence from clinical studies for any of the botanicals reviewed, it is premature to actively recommend use of any particular herb to treat either glucose or other risk factors. Thus, well defined randomized clinical trials are warranted in this area. PMID:18537692

  17. Efficacy of Supplementation with B Vitamins for Stroke Prevention: A Network Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Dong, Hongli; Pi, Fuhua; Ding, Zan; Chen, Wei; Pang, Shaojie; Dong, Wenya; Zhang, Qingying

    2015-01-01

    Background Supplementation with B vitamins for stroke prevention has been evaluated over the years, but which combination of B vitamins is optimal for stroke prevention is unclear. We performed a network meta-analysis to assess the impact of different combinations of B vitamins on risk of stroke. Methods A total of 17 trials (86 393 patients) comparing 7 treatment strategies and placebo were included. A network meta-analysis combined all available direct and indirect treatment comparisons to evaluate the efficacy of B vitamin supplementation for all interventions. Results B vitamin supplementation was associated with reduced risk of stroke and cerebral hemorrhage. The risk of stroke was lower with folic acid plus vitamin B6 as compared with folic acid plus vitamin B12 and was lower with folic acid plus vitamin B6 plus vitamin B12 as compared with placebo or folic acid plus vitamin B12. The treatments ranked in order of efficacy for stroke, from higher to lower, were folic acid plus vitamin B6 > folic acid > folic acid plus vitamin B6 plus vitamin B12 > vitamin B6 plus vitamin B12 > niacin > vitamin B6 > placebo > folic acid plus vitamin B12. Conclusions B vitamin supplementation was associated with reduced risk of stroke; different B vitamins and their combined treatments had different efficacy on stroke prevention. Folic acid plus vitamin B6 might be the optimal therapy for stroke prevention. Folic acid and vitamin B6 were both valuable for stroke prevention. The efficacy of vitamin B12 remains to be studied. PMID:26355679

  18. Cinryze as the first approved C1 inhibitor in the USA for the treatment of hereditary angioedema: approval, efficacy and safety.

    PubMed

    Lunn, Michael; Santos, Carah; Craig, Timothy

    2010-01-01

    Hereditary angioedema (HAE) is a clinical disorder characterized by a deficiency of C1 esterase inhibitor (C1-INH). HAE has traditionally been divided into two subtypes. Unique among the inherited deficiencies of the complement system, HAE Types I and II are inherited as an autosomal dominant disorder. The generation of an HAE attack is caused by the depletion and/or consumption of C1-inhibitor manifested as subcutaneous or submucosal edema of the upper airway, face, extremities, or gastrointestinal tract. Attacks can be severe and potentially life-threatening, particularly with laryngeal involvement. Despite the availability of C1-INH for the treatment of HAE since the 1980s in Europe and other countries, HAE treatment in the United States was limited to androgen therapy. The human plasma-derived C1 esterase inhibitor (Cinryze™), distributed by Lev Pharmaceuticals, was approved in October 2008 for the prevention of HAE attacks based on the results of a phase III clinical trial. This review aims to describe the history of C1-INH replacement in HAE as well as the pharmacology, efficacy and safety of C1-INH, concentrating on Cinryze as the first approved chronic replacement treatment for the prophylaxis of HAE attacks. PMID:22282695

  19. Efficacy of some antioxidants supplementation in reducing oxidative stress post sodium tungstate exposure in male wistar rats.

    PubMed

    Sachdeva, S; Flora, S J S

    2014-04-01

    This study aimed to evaluate the protective efficacy of some antioxidants against sodium tungstate induced oxidative stress in male wistar rats. Animals were sub-chronically exposed to sodium tungstate (100ppm in drinking water) for three months except for control group. In the same time, many rats were supplemented orally with different antioxidants (alpha-lipoic acid (ALA), n-acetylcysteine (NAC), quercetin or naringenin (0.30mM)) for five consecutive days a week for the same mentioned period before. Exposure to sodium tungstate significantly (P<0.05) inhibit blood δ-aminolevulinic acid dehydratase (ALAD) activity, liver and blood reduced glutathione (GSH) levels and an increase in oxidized glutathione (GSSG) and thiobarbituric acid reactive species (TBARS) levels in tissues. ALA acid and NAC supplementation post sodium tungstate exposure increased GSH and also, was beneficial in the recovery of altered superoxide dismutase and catalase activity, besides, significantly reducing blood and tissue reactive oxygen species and TBARS levels. The results suggest a more pronounced efficacy of ALA acid and NAC supplementation than quercetin or naringenin supplementation post sodium tungstate exposure in preventing induced oxidative stress in rats. PMID:24613855

  20. Review of the efficacy of green tea, isoflavones and aloe vera supplements based on randomised controlled trials.

    PubMed

    Williamson, Gary; Coppens, Patrick; Serra-Majem, Lluís; Dew, Tristan

    2011-12-01

    We assess the evidence for health benefits of three commonly consumed plant food supplements (PFS), green tea, isoflavone and aloe vera, based on published systematic reviews of randomised controlled trials (RCTs). Whilst the potential benefits of green tea have been reported in a wide range of health areas, it is only in the area of the metabolic syndrome that the number of RCTs is approaching sufficient to judge such efficacy. Isoflavone supplements are widely used, and RCTs indicate that they affect bone resorption at lower doses in postmenopausal women undergoing estrogen-related bone loss, but this is only translated to attenuation of bone loss at higher doses of isoflavones. A systematic review on RCTs concluded that the effects of isoflavones on hot flashes in postmenopausal women were highly variable and no conclusions could be drawn. Despite the popularity of aloe vera as a PFS, the evaluation of its efficacy as a coadjuvant therapy for certain metabolic or digestive pathologies remains scarce; it constitutes a typical example of a naturally occurring ingredient whose efficacy in topical applications presupposes its efficacy in systemic applications. Nevertheless, its possible toxic effects on oral consumption call for caution in its utility as a PFS. Since 2007, efficacy evaluation of PFS in Europe has been covered by European Union Nutrition and Health Claims legislation. The European Food Safety Authority has adopted an approach relying on RCTs, while medicinal effects are accepted based on traditional use. In general, there are insufficient RCTs for claims to be made, and conclusive results on PFS should be obtained in the future by conducting studies with more homogeneous populations, by using supplements with optimised and measured bioavailability, and by conducting larger RCTs. PMID:21927741

  1. Nutritional supplement use by elite young UK athletes: fallacies of advice regarding efficacy

    PubMed Central

    Petróczi, Andrea; Naughton, Declan P; Pearce, Gemma; Bailey, Richard; Bloodworth, Andrew; McNamee, Michael

    2008-01-01

    Background The objective was to study nutritional supplement use among young elite UK athletes to establish whether a rationale versus practice incongruence exists, and to investigate the sources of information. Survey data were analysed for association between supplements used and motives for using such substances among young athletes along with the sources of advice and literature precedents on supplement effects. Methods Participants were elite UK male and female athletes, within the age range between 12 and 21 (n = 403), mean age 17.66 ± 1.99. Associations between type of supplements and reasons for using supplements were tested by calculating Pearson's χ2 and the strength of these symmetric associations shown by phi (ϕ) association coefficients. Results Single supplement use was reported by 48.1%, with energy drinks being the most popular, consumed by 41.7% of all athletes and 86.6% of the supplement users in the sample. No agreement was observed between athletes' rationale and behaviour in relation to nutritional supplements except for creatine. Among health professionals, nutritionists and physiotherapists, followed by coaches, were most frequently consulted. Answers regarding reasons and supplements used showed incongruence and suggest widespread misinformation regarding supplements and their effects is an issue for the young athlete. Conclusion Widespread supplement taking behaviour was evidenced in the young elite athlete population with the most notable congruence between rationale and practice among young athletes being performance-related. Young athletes in the present sample appear to be less 'health conscious' and more 'performance focused' than their adult counterparts. Further research, using a full list of supplements, is warranted to test the hypothesis that health consciousness is less dominant in supplement choice by young athletes. PMID:19077317

  2. Anti-fall Efficacy of Oral Supplemental Vitamin D and Active Vitamin D

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Results from fall prevention trials with supplemental vitamin D have been mixed and trials varied by dose, type of vitamin D (D3 = cholecalciferol or D2 = ergocalciferol), and quality of fall assessment. A possible differential benefit of supplemental versus alpha-hydroxylated vitamin D (active D) h...

  3. Efficacy of a crosslinked hyaluronic acid-based hydrogel as a tear film supplement: a masked controlled study.

    PubMed

    Williams, David L; Mann, Brenda K

    2014-01-01

    Keratoconjunctivitis sicca (KCS), or dry eye, is a significant medical problem in both humans and dogs. Treating KCS often requires the daily application of more than one type of eye drop in order to both stimulate tear prodcution and provide a tear supplement to increase hydration and lubrication. A previous study demonstrated the potential for a crosslinked hyaluronic acid-based hydrogel (xCMHA-S) to reduce the clinical signs associated with KCS in dogs while using a reduced dosing regimen of only twice-daily administration. The present study extended those results by comparing the use of the xCMHA-S to a standard HA-containing tear supplement in a masked, randomized clinical study in dogs with a clinical diagnosis of KCS. The xCMHA-S was found to significantly improve ocular surface health (conjunctival hyperaemia, ocular irritation, and ocular discharge) to a greater degree than the alternative tear supplement (P = 0.0003). Further, owners reported the xCMHA-S treatment as being more highly effective than the alternative tear supplement (P = 0.0024). These results further demonstrate the efficacy of the xCMHA-S in reducing the clinical signs associated with KCS, thereby improving patient health and owner happiness. PMID:24914681

  4. Efficacy of progesterone supplementation during early pregnancy in cows: A meta-analysis.

    PubMed

    Yan, Leyan; Robinson, Robert; Shi, Zhendan; Mann, George

    2016-05-01

    Progesterone is a critical hormone during early pregnancy in the cow. As a result, a number of studies have investigated the effects of progesterone supplementation on pregnancy rates. In this study, a meta-analysis using a univariate binary random effects model was carried out on 84 specific treatments reported in 53 publications involving control (n = 9905) and progesterone-treated (n = 9135) cows. Although the results of individual studies showed wide variations (-40% to +50% point changes), progesterone treatment resulted in an overall increase in pregnancy rate odds ratio (OR = 1.12; P < 0.01). Improvements in pregnancy rate were only observed in cows treated at natural estrus (OR = 1.41, P < 0.01) and not following synchronization of estrus or ovulation. Although treatment between Days 3 to 7 postinsemination was beneficial (OR = 1.15; P < 0.01), treatment earlier or later than this was not. Progesterone supplementation was beneficial in cows of lower fertility (<45% control pregnancy rate) but not in cows with higher fertility. These results indicated that the benefit of progesterone supplementation on fertility of cows required exogenous progesterone supplementation to start between Day 3 to 7 and the appropriate reproductive status (i.e., lower fertility, natural estrus) of the treated cows. PMID:26822872

  5. Prognostic Role of Vitamin D Status and Efficacy of Vitamin D Supplementation in Cancer Patients: A Systematic Review

    PubMed Central

    Buttigliero, Consuelo; Monagheddu, Chiara; Petroni, Paola; Saini, Andrea; Dogliotti, Luigi; Ciccone, Giovannino

    2011-01-01

    Background. Whether or not hypovitaminosis D can influence the prognosis of cancer patients and whether or not vitamin D (vitD) supplementation improves outcome remain controversial. Design. Studies evaluating the prognostic role of vitD and vitD receptor (VDR) in cancer patients and trials evaluating the efficacy of vitD administration on patient outcome were identified by a search of MEDLINE, EMBASE, ISI Web of Knowledge, and the Cochrane Library through June 2010. Results. Twenty-five studies were included. A negative prognostic role for low serum vitD level was observed in five cohort studies including patients with breast cancer (one study), colon cancer (two studies), prostate cancer (one study), and melanoma (one study), but not in two studies on non-small cell lung cancer and one study on breast cancer. Three of four studies showed that VDR+ tumors carry a better prognosis than VDR− tumors, whereas VDR polymorphisms were significantly associated with prognosis in five of 10 studies. A significant interaction between serum vitD level and VDR polymorphism was observed in one study. Three randomized trials involving advanced prostate cancer patients explored the prognostic role of vitD supplementation. A meta-analysis of these trials showed no effect on survival (pooled risk ratio, 1.07; 95% confidence interval, CI, 0.93–1.23), with strong heterogeneity among studies. Conclusion. Hypovitaminosis D seems to be associated with a worse prognosis in some cancers, but vitD supplementation failed to demonstrate a benefit in prostate cancer patients. The currently available evidence is insufficient to recommend vitD supplementation in cancer patients in clinical practice. PMID:21835895

  6. Dosing and efficacy of glutamine supplementation in human exercise and sport training.

    PubMed

    Gleeson, Michael

    2008-10-01

    Some athletes can have high intakes of l-glutamine because of their high energy and protein intakes and also because they consume protein supplements, protein hydrolysates, and free amino acids. Prolonged exercise and periods of heavy training are associated with a decrease in the plasma glutamine concentration and this has been suggested to be a potential cause of the exercise-induced immune impairment and increased susceptibility to infection in athletes. However, several recent glutamine feeding intervention studies indicate that although the plasma glutamine concentration can be kept constant during and after prolonged strenuous exercise, the glutamine supplementation does not prevent the postexercise changes in several aspects of immune function. Although glutamine is essential for lymphocyte proliferation, the plasma glutamine concentration does not fall sufficiently low after exercise to compromise the rate of proliferation. Acute intakes of glutamine of approximately 20-30 g seem to be without ill effect in healthy adult humans and no harm was reported in 1 study in which athletes consumed 28 g glutamine every day for 14 d. Doses of up to 0.65 g/kg body mass of glutamine (in solution or as a suspension) have been reported to be tolerated by patients and did not result in abnormal plasma ammonia levels. However, the suggested reasons for taking glutamine supplements (support for immune system, increased glycogen synthesis, anticatabolic effect) have received little support from well-controlled scientific studies in healthy, well-nourished humans. PMID:18806122

  7. Efficacy and Interaction of Antioxidant Supplements as Adjuvant Therapy in Cancer Treatment: A Systematic Review.

    PubMed

    Yasueda, Asuka; Urushima, Hayato; Ito, Toshinori

    2016-03-01

    Oxidative stress is a key component in carcinogenesis. Although radiation produces reactive oxygen species, some anticancer agents such as alkylating agents, platinum and antitumor antibiotics exert cytotoxicity by generating free radicals. Nonenzymatic exogenous antioxidants such as vitamins, minerals, and polyphenols can quench ROS activity. However, whether antioxidants alter antitumor effects during radiotherapy and some types of chemotherapy remains unclear. In the present study, we reviewed antioxidants as an adjuvant therapy for cancer patients during chemotherapy or radiotherapy. Electronic literature searches were performed to select all randomized controlled clinical trials (RCTs) in which antioxidants were administered to cancer patients along with chemotherapy or radiotherapy. Articles or abstracts written in English were included. In total, 399 reports received primary screening. Duplicated articles and those meeting the exclusion criteria (not RCT, not human, and no oral administration) were excluded. Finally, 49 reports matching the inclusion criteria were included. It was difficult to determine whether antioxidants affect treatment outcomes or whether antioxidants ameliorate adverse effects induced by chemotherapy and radiotherapy. It is desirable to use an evidence-based method to select supplements best suited to cancer patients. Although there are many opinions about risks or benefits of antioxidant supplementation, we could mostly conclude that the harm caused by antioxidant supplementation remains unclear for patients during cancer therapy, except for smokers undergoing radiotherapy. PMID:26503419

  8. Measuring the Impact of a Supplemental Civic Education Program on Students' Civic Attitude and Efficacy Beliefs

    ERIC Educational Resources Information Center

    Piñgul, Ferdinand S.

    2015-01-01

    This study examines the impact of Project Citizen Philippines, an extra-classroom civic education program, on its 3rd and 4th year high school participants' civic attitude and efficacy beliefs. Three hundred forty three participants and 107 non-participants from various public high schools in the Philippines' National Capital Region were compared…

  9. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What requirements apply to a returned dietary... CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a...

  10. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What requirements apply to a returned dietary... CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a...

  11. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What requirements apply to a returned dietary... CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a...

  12. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What requirements apply to a returned dietary... CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a...

  13. Efficacy of Systemic Vitamin C Supplementation in Reducing Corneal Opacity Resulting from Infectious Keratitis

    PubMed Central

    Cho, Yong-Wun; Yoo, Woong-Sun; Kim, Seong-Jae; Chung, In-Young; Seo, Seong-Wook; Yoo, Ji-Myong

    2014-01-01

    Abstract The objective of this study was to determine the effect of vitamin C supplementation on reducing the size of corneal opacity resulting from infectious keratitis. The study included 82 patients (82 affected eyes), admitted for infectious keratitis from January 2009 to August 2013, who were followed for more than 3 months. Patients were divided into control, oral vitamin C (3 g/d), and intravenous vitamin C (20 g/d) groups during hospitalization. Corneal opacity sizes were measured using anterior segment photographs and Image J program (version 1.27; National Institutes of Health, Jinju, South Korea) at admission, discharge, and final follow-up. The corneal opacity size used for analysis was the measured opacity size divided by the size of the whole cornea. The corneal opacity size decreased by 0.03 ± 0.10 in the oral vitamin C group, 0.07 ± 0.22 in the intravenous vitamin C group, and 0.02 ± 0.15 in the control group. Intravenous vitamin C reduced the corneal opacity size more than oral vitamin C (P = 0.043). Intravenous vitamin C produced greater reduction in corneal opacity size in younger patients (P = 0.015) and those with a hypopyon (P = 0.036). Systemic vitamin C supplementation reduced the size of corneal opacity resulting from infectious keratitis. Intravenous vitamin C was more beneficial than oral supplementation, especially in younger patients and those with hypopyon. PMID:25415664

  14. A Bridge to Developing Efficacious Science Teachers of "All" Students: Community-Based Service-Learning Supplemented with Explicit Discussions and Activities about Diversity

    ERIC Educational Resources Information Center

    Cone, Neporcha

    2009-01-01

    This study explored the effects of community-based service-learning (CBSL), supplemented with discussions and activities about diversity, on the self-efficacy beliefs of preservice elementary teachers regarding equitable science teaching and learning for diverse student groups. The study was conducted with 81 preservice teachers enrolled in four…

  15. An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylamine (BMPEA), is found in multiple dietary supplements.

    PubMed

    Cohen, Pieter A; Bloszies, Clayton; Yee, Caleb; Gerona, Roy

    2016-01-01

    The amphetamine isomer β-methylphenylethylamine (BMPEA) was first synthesized in the early 1930s, but its efficacy and safety in humans has not been studied. Recently, the United States Food and Drug Administration (FDA) detected BMPEA in dietary supplements labelled as containing Acacia rigidula. Over a year after the FDA reported its findings, we analyzed Acacia rigidula dietary supplements to determine if BMPEA had been removed. Supplements were analyzed using liquid chromatography-quadrupole time-of-flight mass spectrometry. Diluted methanolic extract from each supplement was run three times and each data set obtained was analyzed using Agilent MassHunter Qualitative Analysis. The presence of BMPEA was confirmed by accurate mass, retention time and mass spectra match against a reference standard. Quantification of BMPEA was determined using an eight-point calibration curve of spiked standard to a matrix blank. Twenty-one brands of Acacia rigidula supplements were analyzed. More than half (11/21; 52.4%) of the Acacia rigidula supplement brands contained BMPEA. The stimulant was present at quantities such that consumers following recommended maximum daily servings would consume a maximum of 93.7 mg of BMPEA per day. Consumers of Acacia rigidula supplements may be exposed to pharmacological dosages of an amphetamine isomer that lacks evidence of safety in humans. The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements. Copyright © 2015 John Wiley & Sons, Ltd. PMID:25847603

  16. Efficacy of micronutrient supplementation on skin aging and seasonal variation: a randomized, placebo-controlled, double-blind study

    PubMed Central

    Fanian, Ferial; Mac-Mary, Sophie; Jeudy, Adeline; Lihoreau, Thomas; Messikh, Rafat; Ortonne, Jean-Paul; Sainthillier, Jean-Marie; Elkhyat, Ahmed; Guichard, Alexandre; Kenari, Kamran Hejazi; Humbert, Philippe

    2013-01-01

    Background Several studies have confirmed dramatic changes in skin surface parameters during the winter months. Although there are many studies supporting the positive effects of topical treatment, there are no published studies demonstrating the effects of oral supplementation in the prevention of negative skin changes during winter. The purpose of this study was to evaluate the efficacy of an oral micronutrient supplement in preventing the negative effects of winter weather on skin quality using noninvasive biometrologic instruments. Methods This study included 80 healthy female volunteers aged 35–55 years with phototype II–IV skin. Randomization was balanced. Two tablets of a micronutrient supplement (Perfectil® Platinum) or placebo were administered once daily for 4 months. The volunteers were examined at baseline, after 4 months, and 6 weeks after termination of treatment (month 5.5). The evaluation included skin microrelief by Visioscan® as the main outcome, and the secondary outcomes were results on standard macrophotography, skin tension by Reviscometer®, skin high-frequency ultrasound, and self-assessment. Results For all pseudoroughness and microrelief indicators, there was a significant increase from baseline to month 4 in the placebo group (P<0.05) but no change in the active group. Descriptive statistics for the mean minimum, mean maximum, and minimum to maximum ratio on the nonexposed study zone showed a significant and dramatic difference between baseline and month 4 and between baseline and month 5.5 (P<0.05) in the active group, indicating decreasing anisotropy of the skin. High-frequency ultrasound on the exposed study zone revealed that skin thickness was significantly decreased in the placebo group during winter but was stable in the treated group (P<0.01). The photography scaling and self-assessment questionnaire revealed no significant changes in either group. Conclusion These results indicate that the skin is prone to seasonal changes

  17. Efficacy of vitamins B supplementation on mild cognitive impairment and Alzheimer's disease: a systematic review and meta-analysis.

    PubMed

    Li, Meng-Meng; Yu, Jin-Tai; Wang, Hui-Fu; Jiang, Teng; Wang, Jun; Meng, Xiang-Fei; Tan, Chen-Chen; Wang, Chong; Tan, Lan

    2014-01-01

    Despite B vitamin supplementation playing an important role in cognitive function, the exact effect remains unknown. The aim of this study was to systematically review and quantitatively synthesize the efficacy of treatment with vitamins B supplementation in slowing the rate of cognitive, behavioral, functional and global decline in individuals with MCI or AD. A systematic literature search in PubMed, EMBASE, International Pharmaceutical Abstracts, clinicaltrials. gov, the Cochrane Controlled Trials Register, the Cochrane Database of Systematic Reviews, and the Cochrane Cognitive Improvement Group specialized registry was conducted on April 2014, with no limit of date. Five trials met the eligibility criteria and were selected for this meta-analysis. Meta-analysis showed moderate beneficial effects of vitamins B supplementation on memory (SMD 0.60, 95% CI 0.20, 1.00), whereas no significant difference on general cognitive function (WMD -0.10, 95% CI -0.80, 0.59), executive function (SMD 0.05, 95% CI -0.11, 0.21) and attention (WMD -0.03, 95% CI -1.20, 1.14) were found in MCI patients. In addition, no significantly cognitive benefits on the Alzheimer's Disease Assessment Scale (ADAS-cog) (WMD 1.01, 95% CI -0.68, 2.70) and Mini Mental State Examination (MMSE) (WMD -0.22, 95% CI -1.00, 0.57), functional (SMD 0.13, 95% CI -0.05, 0.31), behavioral (SMD 0.04, 95% CI -0.16, 0.25) or global (WMD 0.07, 95% CI -0.48, 0.62) change were observed in AD patients. Collectively, weak evidence of benefits was observed for the domains of memory in patients with MCI. Nevertheless, future standard RCTs are still needed to determine whether it was still significant in larger populations. However, the data does not yet provide adequate evidence of an effect of vitamins B on general cognitive function, executive function and attention in people with MCI. Similarly, folic acid alone or vitamins B in combination are unable to stabilize or slow decline in cognition, function, behavior, and

  18. 30 CFR 550.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) Change the type of production or significantly increase the volume of production or storage capacity; (4) Increase the emissions of an air pollutant to an amount that exceeds the amount specified in your approved... EP, DPP, or DOCD? 550.283 Section 550.283 Mineral Resources BUREAU OF OCEAN ENERGY...

  19. 30 CFR 550.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) Change the type of production or significantly increase the volume of production or storage capacity; (4) Increase the emissions of an air pollutant to an amount that exceeds the amount specified in your approved... EP, DPP, or DOCD? 550.283 Section 550.283 Mineral Resources BUREAU OF OCEAN ENERGY...

  20. 30 CFR 550.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) Change the type of production or significantly increase the volume of production or storage capacity; (4) Increase the emissions of an air pollutant to an amount that exceeds the amount specified in your approved... EP, DPP, or DOCD? 550.283 Section 550.283 Mineral Resources BUREAU OF OCEAN ENERGY...

  1. Efficacy of supplementation of selected medicinal mushrooms with inorganic selenium salts.

    PubMed

    Niedzielski, Przemysław; Mleczek, Mirosław; Siwulski, Marek; Gąsecka, Monika; Kozak, Lidia; Rissmann, Iwona; Mikołajczak, Patrycja

    2014-01-01

    The aim of the study was to evaluate the possibility of supplementation with inorganic forms of selenium (Na2SeO4 and Na2SeO3) in concentrations of 0, 0.1, 0.2, 0.4, 0.6, 0.8, 1.0 and 1.5 mM of three medicinal mushroom species: Agrocybe aegerita, Hericium erinaceus and Ganoderma lucidum. Tested mushroom species grew in Se additions of 0-0.6 mM (A. aegerita and H. erinaceus), while growth of G. lucidum bodies was observed for 0-0.8 mM. For the latter mushroom species, the total Se content was the highest. Content of Seorg was diverse; for control bodies it was the highest for G. lucidum (only organic forms were present), lower for A. aegerita (84% organic forms) and the lowest for H. erinaceus (56% organic forms). Accumulation of Se(IV) was generally significantly higher than Se(VI) for all tested mushroom species. There was no significant decrease of A. aegerita or G. lucidum biomass with the exception of G. lucidum bodies growing under 0.8 mM of Se species addition (15.51 ± 6.53 g). Biomass of H. erinaceus bodies was the highest under 0.2 (197.04 ± 8.73 g), control (191.80 ± 6.06 g) and 0.1 mM (185.04 ± 8.73 g) of both inorganic salts. The addition to the medium of Se salts brought about macroscopic changes in the fruiting bodies of the examined mushrooms. Concentrations exceeding 0.4 mM caused diminution of carpophores or even their total absence. In addition, colour changes of fruiting bodies were also recorded. At Se concentrations of 0.4 and 0.6 mM, A. aegerita fruiting bodies were distinctly lighter and those of H. erinaceus changed colour from purely white to white-pink. PMID:25310808

  2. 78 FR 21398 - Notice of Intent to Prepare a Supplemental Environmental Impact Statement for the Approval of a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-10

    ...This notice advises the public that the National Indian Gaming Commission (NIGC) as lead agency, in cooperation with the Jamul Indian Village (Tribe), intends to gather information necessary to prepare a supplemental environmental impact statement (SEIS) for the proposed Gaming Management Contract between the Tribe and San Diego Gaming Ventures, LLC (SDGV). The Gaming Management Contract, if......

  3. 75 FR 35044 - Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-21

    ... Application; Penicillin G Procaine Suspension AGENCY: Food and Drug Administration, HHS. ACTION: Notice... for a revised formulation of penicillin G procaine injectable suspension that includes lecithin as a... 6JP, Northern Ireland, filed a supplement to NADA 065-010 for use of NOROCILLIN (penicillin G...

  4. Efficacy of phytosterols and fish-oil supplemented high-oleic-sunflower oil rich diets in hypercholesterolemic growing rats.

    PubMed

    Alsina, Estefania; Macri, Elisa V; Lifshitz, Fima; Bozzini, Clarisa; Rodriguez, Patricia N; Boyer, Patricia M; Friedman, Silvia M

    2016-06-01

    Phytosterols (P) and fish-oil (F) efficacy on high-oleic-sunflower oil (HOSO) diets were assessed in hypercholesterolemic growing rats. Controls (C) received a standard diet for 8 weeks; experimental rats were fed an atherogenic diet (AT) for 3 weeks, thereafter were divided into four groups fed for 5 weeks a monounsaturated fatty acid diet (MUFA) containing either: extra virgin olive oil (OO), HOSO or HOSO supplemented with P or F. The diets did not alter body weight or growth. HOSO-P and HOSO-F rats showed reduced total cholesterol (T-chol), non-high-density lipoprotein-cholesterol (non-HDL-chol) and triglycerides and increased HDL-chol levels, comparably to the OO rats. Total body fat (%) was similar among all rats; but HOSO-F showed the lowest intestinal, epididymal and perirenal fat. However, bone mineral content and density, and bone yield stress and modulus of elasticity were unchanged. Growing hypercholesterolemic rats fed HOSO with P or F improved serum lipids and fat distribution, but did not influence material bone quality. PMID:26983467

  5. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false PMA supplements. 814.39 Section 814.39 Food and... PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. (a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by...

  6. Evaluation Series on Safety and Efficacy of Nutritional Supplements in Newly Diagnosed Hyperglycemia: A Placebo-Controlled, Randomized Study

    PubMed Central

    Thacker, Hemant; Bantwal, Ganapati; Jain, Sunil; Kalra, Sanjay; Kale, Shailaja; Saboo, Banshi; Gupta, Jugal B.; Sivam, Sakthivel

    2016-01-01

    Background: Diabetes is endemic with developing economies contributing to the bulk of this pandemic. Despite the evidence of incremental benefit of glycemic control starting early in life, acceptance of and adherence to modern medications remain suboptimal. Aims: To determine the hemoglobin A1c (HbA1c)-lowering efficacy and safety of nutritional supplement, PreCrea®, in adult Indians with newly diagnosed hyperglycemia. Materials and Methods: Double-blind, randomized study conducted in six diabetes centers in India. A total of 193 treatment-naïve subjects with newly diagnosed hyperglycemia and fasting plasma glucose (FPG) >100 mg/dL were randomized into either PreCrea® 600 mg (n = 90) or matched placebo (n = 89) capsules twice daily, along with lifestyle modification, for 12 weeks. The main outcomes were changes in HbA1c and FPG levels, attainment of the American Diabetes Association (ADA)-defined goals for HbA1c, and clinical and biochemical measures of safety. Results: At 12 weeks, mean HbA1c in PreCrea® group reduced by 0.91% compared with 0.08% increase in the placebo group (P < .001). The reductions in the mean FPG at week 4 (P < .001) and week 12 (P = 0.04) were significant compared to the baseline. ADA goal of HbA1c <7% increased from 15.5% at the baseline to 35.6% at week 12 in PreCrea® subjects. Clinical safety and biochemical safety did not change. Hypoglycemia and weight gain were not observed with PreCrea®. Conclusions: Nearly 1% point reduction in HbA1c at week 12 with PreCrea® is comparable with most first-line glucose-lowering drugs. The safety and tolerability of PreCrea® highlights its potential as a first-line therapy in newly detected hyperglycemia. PMID:27042609

  7. Smear layer removal efficacy of combination of herbal extracts in two different ratios either alone or supplemented with sonic agitation: An in vitro scanning electron microscope study

    PubMed Central

    Chhabra, Naveen; Gyanani, Hitesh; Kamatagi, Laxmikant

    2015-01-01

    Objectives: The study aimed to evaluate the effectiveness of the combination of two natural extracts in varying ratios for removal of smear layer either alone or supplemented with sonic agitation. Materials and Methods: Fifty extracted single-rooted teeth were collected, disinfected and decoronated below the cementoenamel junction to obtain standardized root length of 10 mm. Root canals were instrumented using rotary files at working length 1 mm short of the apex. Specimens were divided into six groups according to the irrigation protocol as follows: Group A – Distilled water, Group B – 17% ethylenediaminetetraacetic acid, Group C – Herbal extracts in 1:1 ratio, Group D – Herbal extracts in 1:1 ratio supplemented with sonic agitation, Group E – Herbal extracts in 2:1 ratio, Group F – Herbal extracts in 2:1 ratio supplemented with sonic agitation. Specimens were longitudinally sectioned and evaluated under scanning electron microscope for smear layer removal efficacy. Obtained scores were statistically analyzed using one-way analysis of variance and post-hoc test. Results: Among all, Group B showed the best results followed by Group F. Remaining other groups showed inferior outcome (P < 0.05). Conclusion: The combination of two extracts in 2:1 ratio was slightly better than 1:1 ratio and the smear layer removal efficacy was further improved when accompanied with sonic agitation. PMID:26430300

  8. Patients' understanding of the regulation of dietary supplements.

    PubMed

    Ashar, Bimal H; Miller, Redonda G; Pichard, Carmen P; Levine, Rachel; Wright, Scott M

    2008-02-01

    The Dietary Supplement Health and Education Act (DSHEA) permits manufacturers to sell products without providing pre-market evidence of safety or efficacy. One fundamental reason for the passage of the DSHEA was to empower consumers to make their own choices, free from governmental restriction. Yet, little is known about the public's understanding of the supplement regulatory process. We undertook a study to assess patients' knowledge regarding governmental oversight of product marketing and advertising. A survey of 300 adult patients from the Baltimore Metropolitan area was administered after showing participants an advertisement for a dietary supplement. Patients were asked questions regarding their understanding of federal regulation of the advertised product. A total of 52% of respondents were unaware that the dietary supplement had not been approved by the government while 63% were unaware that the advertisement for that supplement had not been pre-approved. Factors associated with a lack of understanding of the product approval process included lower education level (OR 2.52; 95% CI 1.52-4.19) and non-Caucasian race (OR 1.99; 95% CI 1.17-3.36). Lower education level was also associated with confusion regarding the advertisement approval process (OR 2.60; 95% CI 1.48-4.57). Based on these results, patients seem unclear about the government's role in the regulation of dietary supplements. Educational efforts should be geared towards clarifying these issues. PMID:18080205

  9. Safety and efficacy of US-approved viscosupplements for knee osteoarthritis: a systematic review and meta-analysis of randomized, saline-controlled trials

    PubMed Central

    Strand, Vibeke; McIntyre, Louis F; Beach, William R; Miller, Larry E; Block, Jon E

    2015-01-01

    Background Intra-articular injection of hyaluronic acid is a common, yet controversial, therapeutic option for patients with knee osteoarthritis (OA). The purpose of this research was to determine the safety and efficacy of US-approved viscosupplements for symptomatic knee OA. Methods We searched MedLine and EMBase for randomized, sham-controlled trials evaluating safety and/or clinical efficacy of US-approved viscosupplements in patients with symptomatic knee OA. Knee pain severity and knee joint function were assessed at 4 to 13 weeks and 14 to 26 weeks. Safety outcomes included serious adverse events, treatment-related serious adverse events, patient withdrawal, and adverse event-related patient withdrawal occurring at any time during follow-up. Results A total of 29 studies representing 4,866 unique patients (active: 2,673, control: 2,193) were included. All sham-controlled trials used saline injections as a control. Viscosupplementation resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to preinjection values, with standardized mean difference values ranging from 1.07 to 1.37 (all P<0.001). Compared to controls, standardized mean difference with viscosupplementation ranged from 0.38 to 0.43 for knee pain and 0.32 to 0.34 for knee function (all P<0.001). There were no statistically significant differences between viscosupplementation and controls for any safety outcome, with absolute risk differences of 0.7% (95% confidence interval [CI]: −0.2 to 1.5%) for serious adverse events, 0% (95% CI: −0.4 to 0.4%) for treatment-related serious adverse events, 0% (95% CI: −1.6 to 1.6%) for patient withdrawal, and 0.2% (95% CI: −0.4 to 0.8%) for adverse event-related patient withdrawal. Conclusion Intra-articular injection of US-approved viscosupplements is safe and efficacious through 26 weeks in patients with symptomatic knee OA. PMID:26005358

  10. Efficacy of folic acid supplementation on endothelial function and plasma homocysteine concentration in coronary artery disease: A meta-analysis of randomized controlled trials

    PubMed Central

    YI, XIN; ZHOU, YANLI; JIANG, DINGSHENG; LI, XIAOYAN; GUO, YI; JIANG, XUEJUN

    2014-01-01

    The aim of the present study was to conduct an updated meta-analysis of relevant randomized controlled trials (RCTs) in order to estimate the effect of folic acid supplementation on endothelial function and the concentration of plasma homocysteine in patients with coronary artery disease (CAD). An extensive search of PubMed was conducted to identify RCTs that compared folic acid with placebo therapy. The mean difference (MD) and 95% confidence interval (CI) were used as a measure of the correlation between folic acid supplementation and endothelial function/plasma homocysteine concentration. Of the 377 patients included in this analysis, 191 patients underwent folic acid supplementation and 186 individuals underwent placebo treatment. Compared with the use of a placebo, folic acid supplementation alone exhibited significant efficacy on increasing flow-mediated dilation (FMD; MD, 57.72 μm; 95% CI, 50.14–65.31; P<0.05) and lowering the concentration of plasma homocysteine (MD, −3.66 μmol/l; 95% CI, −5.44–−1.87; P<0.05; I2, 87%). There was no significant change in the response to end diastolic diameter, glyceryl-trinitrate diameter, heart rate, baseline and peak hyperemic flow and systolic and diastolic blood pressure between the folic acid and placebo groups (P>0.05). Therefore, the meta-analysis indicated that 5 mg folic acid daily supplementation for >4 weeks significantly improved FMD and lowered the concentration of plasma homocysteine in patients with CAD. However, more RCTs are required in order to confirm these observations. PMID:24940394

  11. Drugs, Herbs and Supplements: MedlinePlus

    MedlinePlus

    ... www.nlm.nih.gov/medlineplus/druginformation.html Drugs, Herbs and Supplements To use the sharing features on ... approved labels included in drug packages, see DailyMed . Herbs and Supplements Browse dietary supplements and herbal remedies ...

  12. Methotrexate catabolism to 7-hydroxy methotrexate in rheumatoid arthritis alters drug efficacy and retention and is reduced by folic acid supplements

    PubMed Central

    Baggott, Joseph E.; Morgan, Sarah L.

    2013-01-01

    Objective Urinary excretion of methotrexate (MTX) and its catabolite 7-hydroxy-MTX (7-OH-MTX) were measured in two 24-hour collections after MTX therapy in patients with rheumatoid arthritis. The effect of folic and folinic acid supplements on this catabolism was determined in patients and in vitro. The effect of this catabolism on MTX efficacy and in vivo retention was determined. Methods Urines were collected after 6 and 7 weeks of therapy. MTX and 7-OH-MTX concentrations were determined by a high performance liquid chromatography mass spectroscopy. Swelling (SW) and pain/tenderness (P/T) indices were measured before and at 6 and 7 weeks of therapy. Patients received either folic or folinic acid supplements (1mg/day) from week 6 to 7. Results Folic acid not folinic acid inhibited aldehyde oxidase (AO), the 7-OH-MTX producing enzyme. Excretion of 7-OH-MTX as % of dose or mg 7-OH-MTX / g creatinine was not normally distributed (n = 39). Patients with marked improvement in SW and P/T indices had lower mean 7-OH-MTX excretion (p <0.05). Folic acid supplementation lowered 7-OH-MTX excretion (p = 0.03). Relatively high 7-OH-MTX excretion was correlated (p<0.05) with relatively high MTX excretion and with relatively low in vivo MTX retention (n = 35). Conclusion Non-normal distribution of 7-OH-MTX excretion suggests at least two phenotypes for this catabolism. Lower 7-OH-MTX formation suggests folic acid inhibition of AO and a better clinical response. Higher 7-OH-MTX formation may interfere with MTX polyglutamylation and binding to enzymes and therefore increase MTX excretion, decrease in vivo MTX retention and efficacy. PMID:19644884

  13. Effect of Medicinal Plant By-products Supplementation to Total Mixed Ration on Growth Performance, Carcass Characteristics and Economic Efficacy in the Late Fattening Period of Hanwoo Steers

    PubMed Central

    Lee, S. J.; Kim, D. H.; Guan, Le Luo; Ahn, S. K.; Cho, K. W.; Lee, Sung S.

    2015-01-01

    This study was conducted to evaluate the effect of medicinal plant by-products (MPB) supplementation to a total mixed ration (TMR) on growth, carcass characteristics and economic efficacy in the late fattening period of Hanwoo steers. Twenty seven steers (body weight [BW], 573±57 kg) were assigned to 3 treatment groups so that each treatment based on BW contained 9 animals. All groups received ad libitum TMR throughout the feeding trial until slaughter (from 24 to 30 months of age) and treatments were as follows: control, 1,000 g/kg TMR; treatment 1 (T1), 970 g/kg TMR and 30 g/kg MPB; treatment 2 (T2), 950 g/kg TMR and 50 g/kg MPB. Initial and final BW were not different among treatments. Resultant data were analyzed using general linear models of SAS. Average daily gain and feed efficiency were higher (p<0.05) for T1 than control, but there was no difference between control and T2. Plasma albumin showed low-, intermediate- and high-level (p<0.05) for control, T1 and T2, whereas non-esterified fatty acid was high-, intermediate- and high-level (p<0.05) for control, T1 and T2, respectively. Carcass weight, carcass rate, backfat thickness and rib eye muscle area were not affected by MPB supplementation, whereas quality and yield grades were highest (p<0.05) for T1 and T2, respectively. Daily feed costs were decreased by 0.5% and 0.8% and carcass prices were increased by 18.1% and 7.6% for T1 and T2 compared to control, resulting from substituting TMR with 30 and 50 g/kg MPB, respectively. In conclusion, the substituting TMR by 30 g/kg MPB may be a potential feed supplement approach to improve economic efficacy in the late fattening period of Hanwoo steers. PMID:26580440

  14. Review of the safety and efficacy of vitamin A supplementation in the treatment of children with severe acute malnutrition

    Technology Transfer Automated Retrieval System (TEKTRAN)

    World Health Organization (WHO) guidelines recommend for children with severe acute malnutrition (SAM), high-dose vitamin A (VA) supplements be given on day 1 of admission, and on days 2 and 14 in the case of clinical signs of vitamin A deficiency (VAD). Daily low-dose VA follows, delivered in a pre...

  15. Supplementation of host response by targeting nitric oxide to the macrophage cytosol is efficacious in the hamster model of visceral leishmaniasis and adds to efficacy of amphotericin B.

    PubMed

    Pandya, Sanketkumar; Verma, Rahul Kumar; Khare, Prashant; Tiwari, Brajendra; Srinivasarao, Dadi A; Dube, Anuradha; Goyal, Neena; Misra, Amit

    2016-08-01

    We investigated efficacy of nitric oxide (NO) against Leishmania donovani. NO is a mediator of host response to infection, with direct parasiticidal activity in addition to its role in signalling to evoke innate macrophage responses. However, it is short-lived and volatile, and is therefore difficult to introduce into infected cells and maintain inracellular concentrations for meaningful periods of time. We incorporated diethylenetriamine NO adduct (DETA/NO), a prodrug, into poly(lactide-co-glycolide) particles of ∼200 nm, with or without amphotericin B (AMB). These particles sustained NO levels in mouse macrophage culture supernatants, generating an area under curve (AUC0.08-24h) of 591.2 ± 95.1 mM × h. Free DETA/NO resulted in NO peaking at 3 h and declining rapidly to yield an AUC of 462.5 ± 193.4. Particles containing AMB and DETA/NO were able to kill ∼98% of promastigotes and ∼76% of amastigotes in 12 h when tested in vitro. Promastigotes and amastigotes were killed less efficiently by particles containing a single drug- either DETA/NO (∼42%, 35%) or AMB (∼90%, 50%) alone, or by equivalent concentrations of drugs in solution. In a pre-clinical efficacy study of power >0.95 in the hamster model, DETA/NO particles were non-inferior to Fungizone® but not Ambisome®, resulting in significant (∼73%) reduction in spleen parasites in 7 days. Particles containing both DETA/NO and AMB were superior (∼93% reduction) to Ambisome®. We conclude that NO delivered to the cytosol of macrophages infected with Leishmania possesses intrinsic activity and adds significantly to the efficacy of AMB. PMID:27183429

  16. Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012).

    PubMed

    Bansal, Dipika; Bhagat, Anil; Schifano, Fabrizio; Gudala, Kapil

    2015-12-01

    The present study aimed at systematically reviewing the role and extent of patient-reported outcomes (PROs) usage within the package of scientific evidence considered for marketing authorization (MA). All regulatory information published by the European Medicines Agency (EMA) for products authorized between January 2008 and December 2012 and appearing in the European Public Assessment Report (EPAR) database was examined for efficacy endpoints. The endpoints here considered included: PROs, clinician reported outcomes (CROs), and laboratory reported outcomes (LROs). LROs were the most frequently reported endpoints. Out of the 180 products here selected, 99 (55%), 67 (37%), and 30 (17%), respectively, used LROs, CROs and PROs as primary endpoints (PEs). PROs as any endpoints were used in 82 (46%) products. Out of these, PROs were documented as PE in 30 (37%), with 27 (33%) products having used PROs both as primary and non-PEs. PRO usage was most frequently identified with nervous system and antineoplastic agents. During the study period, the use of all the three types of endpoints appeared to be static. Both the regulatory bodies and the industry should ensure complete and clear reporting of all endpoints used, including PROs, to improve transparency. PMID:26031612

  17. A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation.

    PubMed

    Mezzasalma, Valerio; Manfrini, Enrico; Ferri, Emanuele; Sandionigi, Anna; La Ferla, Barbara; Schiano, Irene; Michelotti, Angela; Nobile, Vincenzo; Labra, Massimo; Di Gennaro, Patrizia

    2016-01-01

    Background and Aim. The efficacy of supplementation treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C and the assessment of their gut microbiota were investigated. Methods. A randomized, double-blind, three-arm parallel group trial was carried out on 150 IBS-C subjects divided into three groups (F_1, F_2, and F_3). Each group received a daily oral administration of probiotic mixtures (for 60 days) F_1 or F_2 or placebo F_3, respectively. Fecal microbiological analyses were performed by species-specific qPCR to assess the different amount of probiotics. Results. The percentage of responders for each symptom was higher in the probiotic groups when compared to placebo group during the treatment period (t60) and was maintained quite similar during the follow-up period (t90). Fecal analysis demonstrated that probiotics of the formulations increased during the times of treatment only in fecal DNA from subjects treated with F_1 and F_2 and not with F_3, and the same level was maintained during the follow-up period. Conclusions. Multispecies probiotic supplementations are effective in IBS-C subjects and induce a different assessment in the composition of intestinal microbiota. This clinical study is registered with the clinical study registration number ISRCTN15032219. PMID:27595104

  18. A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation

    PubMed Central

    Manfrini, Enrico; Ferri, Emanuele; La Ferla, Barbara; Schiano, Irene; Michelotti, Angela; Nobile, Vincenzo

    2016-01-01

    Background and Aim. The efficacy of supplementation treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C and the assessment of their gut microbiota were investigated. Methods. A randomized, double-blind, three-arm parallel group trial was carried out on 150 IBS-C subjects divided into three groups (F_1, F_2, and F_3). Each group received a daily oral administration of probiotic mixtures (for 60 days) F_1 or F_2 or placebo F_3, respectively. Fecal microbiological analyses were performed by species-specific qPCR to assess the different amount of probiotics. Results. The percentage of responders for each symptom was higher in the probiotic groups when compared to placebo group during the treatment period (t60) and was maintained quite similar during the follow-up period (t90). Fecal analysis demonstrated that probiotics of the formulations increased during the times of treatment only in fecal DNA from subjects treated with F_1 and F_2 and not with F_3, and the same level was maintained during the follow-up period. Conclusions. Multispecies probiotic supplementations are effective in IBS-C subjects and induce a different assessment in the composition of intestinal microbiota. This clinical study is registered with the clinical study registration number ISRCTN15032219. PMID:27595104

  19. Haptoglobin phenotype, preeclampsia risk and the efficacy of vitamin C and E supplementation to prevent preeclampsia in a racially diverse population.

    PubMed

    Weissgerber, Tracey L; Gandley, Robin E; McGee, Paula L; Spong, Catherine Y; Myatt, Leslie; Leveno, Kenneth J; Thorp, John M; Mercer, Brian M; Peaceman, Alan M; Ramin, Susan M; Carpenter, Marshall W; Samuels, Philip; Sciscione, Anthony; Harper, Margaret; Tolosa, Jorge E; Saade, George; Sorokin, Yoram

    2013-01-01

    Haptoglobin's (Hp) antioxidant and pro-angiogenic properties differ between the 1-1, 2-1, and 2-2 phenotypes. Hp phenotype affects cardiovascular disease risk and treatment response to antioxidant vitamins in some non-pregnant populations. We previously demonstrated that preeclampsia risk was doubled in white Hp 2-1 women, compared to Hp 1-1 women. Our objectives were to determine whether we could reproduce this finding in a larger cohort, and to determine whether Hp phenotype influences lack of efficacy of antioxidant vitamins in preventing preeclampsia and serious complications of pregnancy-associated hypertension (PAH). This is a secondary analysis of a randomized controlled trial in which 10,154 low-risk women received daily vitamin C and E, or placebo, from 9-16 weeks gestation until delivery. Hp phenotype was determined in the study prediction cohort (n = 2,393) and a case-control cohort (703 cases, 1,406 controls). The primary outcome was severe PAH, or mild or severe PAH with elevated liver enzymes, elevated serum creatinine, thrombocytopenia, eclampsia, fetal growth restriction, medically indicated preterm birth or perinatal death. Preeclampsia was a secondary outcome. Odds ratios were estimated by logistic regression. Sampling weights were used to reduce bias from an overrepresentation of women with preeclampsia or the primary outcome. There was no relationship between Hp phenotype and the primary outcome or preeclampsia in Hispanic, white/other or black women. Vitamin supplementation did not reduce the risk of the primary outcome or preeclampsia in women of any phenotype. Supplementation increased preeclampsia risk (odds ratio 3.30; 95% confidence interval 1.61-6.82, p<0.01) in Hispanic Hp 2-2 women. Hp phenotype does not influence preeclampsia risk, or identify a subset of women who may benefit from vitamin C and E supplementation to prevent preeclampsia. PMID:23573260

  20. Efficacy of Folic Acid Supplementation in Autistic Children Participating in Structured Teaching: An Open-Label Trial

    PubMed Central

    Sun, Caihong; Zou, Mingyang; Zhao, Dong; Xia, Wei; Wu, Lijie

    2016-01-01

    Autism spectrum disorders (ASD) are recognized as a major public health issue. Here, we evaluated the effects of folic acid intervention on methylation cycles and oxidative stress in autistic children enrolled in structured teaching. Sixty-six autistic children enrolled in this open-label trial and participated in three months of structured teaching. Forty-four children were treated with 400 μg folic acid (two times/daily) for a period of three months during their structured teaching (intervention group), while the remaining 22 children were not given any supplement for the duration of the study (control group). The Autism Treatment Evaluation Checklist (ATEC) and Psychoeducational Profile-third edition (PEP-3) were measured at the beginning and end of the treatment period. Folic acid, homocysteine, and glutathione metabolism in plasma were measured before and after treatment in 29 autistic children randomly selected from the intervention group and were compared with 29 age-matched unaffected children (typical developmental group). The results illustrated folic acid intervention improved autism symptoms towards sociability, cognitive verbal/preverbal, receptive language, and affective expression and communication. Furthermore, this treatment also improved the concentrations of folic acid, homocysteine, and normalized glutathione redox metabolism. Folic acid supplementation may have a certain role in the treatment of children with autism. PMID:27338456

  1. Preliminary assessment of the efficacy of supplementing knee extension capability in a lower limb exoskeleton with FES.

    PubMed

    Quintero, Hugo A; Farris, Ryan J; Ha, Kevin; Goldfarb, Michael

    2012-01-01

    The authors describe a cooperative controller that combines the knee joint actuation of an externally powered lower limb exoskeleton with the torque and power contribution from the electrically stimulated quadriceps muscle group. The efficacy of combining these efforts is experimentally validated with a series of weighted leg lift maneuvers. Measurements from these experiments indicate that the control approach effectively combines the respective efforts of the motor and muscle, such that good control performance is achieved, with substantial torque and energy contributions from both the biological and non-biological actuators. PMID:23366646

  2. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false PMA supplements. 814.39 Section 814.39 Food and... PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. Link to an amendment published at 75 FR 16351, Apr. 1, 2010. (a) After FDA's approval of a PMA, an...

  3. Comparative evaluation of efficacy and safety profile of rhubarb and α-keto analogs of essential amino acids supplementation in patients with diabetic nephropathy.

    PubMed

    Khan, Irfan Ahmad; Nasiruddin, Mohammad; Haque, Shahzad F; Khan, Rahat A

    2016-01-01

    To determine the efficacy and safety profile of rhubarb and α-keto analogs of essential amino acids supplementation in patients of diabetic nephropathy (DN), we studied 96 patients of DN attending a tertiary care center of the North India. The patients were randomly divided into three equal interventional groups. Group I (control) that received conservative management along with placebo, Group II (rhubarb) that received conservative management along with rhubarb capsule (350 mg, thrice daily), and Group III [keto amino acid (KAA)] that received conservative management along with α-keto analogs of essential amino acids (600 mg, thrice daily). The treatment was continued for 12 weeks. Clinical and biochemical parameters were assessed at 0, 4, 8, and 12 weeks of treatment. A progressive improvement in clinical features and biochemical parameters was seen in all three groups after 12 weeks of treatment. The KAA group showed more marked improvement in clinical features as well as biochemical parameters compared to the rhubarb group. There was a reduction in blood glucose, blood urea, serum creatinine, and 24 h total urine protein. There was an increase in hemoglobin, 24 h total urine volume, and glomerular filtration rate. There was no statistical difference between the rhubarb and KAA groups with respect to side effects (P > 0.05). Our study suggests that KAA is more effective than rhubarb as add-on therapy with conservative management in patients of DN. PMID:27424687

  4. Ingesting a preworkout supplement containing caffeine, creatine, β-alanine, amino acids, and B vitamins for 28 days is both safe and efficacious in recreationally active men.

    PubMed

    Kendall, Kristina L; Moon, Jordan R; Fairman, Ciaran M; Spradley, Brandon D; Tai, Chih-Yin; Falcone, Paul H; Carson, Laura R; Mosman, Matt M; Joy, Jordan M; Kim, Michael P; Serrano, Eric R; Esposito, Enrico N

    2014-05-01

    The purpose of this study was to determine the safety and efficacy of consuming a preworkout supplement (SUP) containing caffeine, creatine, β-alanine, amino acids, and B vitamins for 28 days. We hypothesized that little to no changes in kidney and liver clinical blood markers or resting heart rate and blood pressure (BP) would be observed. In addition, we hypothesized that body composition and performance would improve in recreationally active males after 28 days of supplementation. In a double-blind, placebo-controlled study, participants were randomly assigned to ingest one scoop of either the SUP or placebo every day for 28 days, either 20 minutes before exercise or ad libitum on nonexercise days. Resting heart rate and BP, body composition, and fasting blood samples were collected before and after supplementation. Aerobic capacity as well as muscular strength and endurance were also measured. Significant (P < .05) main effects for time were observed for resting heart rate (presupplementation, 67.59 ± 7.90 beats per minute; postsupplementation, 66.18 ± 7.63 beats per minute), systolic BP (presupplementation, 122.41 ± 11.25 mm Hg; postsupplementation, 118.35 ± 11.58 mm Hg), blood urea nitrogen (presupplementation, 13.12 ± 2.55 mg/dL; postsupplementation, 15.24 ± 4.47 mg/dL), aspartate aminotransferase (presupplementation, 34.29 ± 16.48 IU/L; postsupplementation, 24.76 ± 4.71 IU/L), and alanine aminotransferase (presupplementation, 32.76 ± 19.72 IU/L; postsupplementation, 24.88 ± 9.68 IU/L). Significant main effects for time were observed for body fat percentage (presupplementation, 15.55% ± 5.79%; postsupplementation, 14.21% ± 5.38%; P = .004) and fat-free mass (presupplementation, 70.80 ± 9.21 kg; postsupplementation, 71.98 ± 9.27 kg; P = .006). A significant decrease in maximal oxygen consumption (presupplementation, 47.28 ± 2.69 mL/kg per minute; postsupplementation, 45.60 ± 2.81 mL/kg per minute) and a significant increase in percentage of

  5. Efficacy and safety of Vitamin D supplementation during pregnancy: A randomized trial of two different levels of dosing on maternal and neonatal Vitamin D outcome

    PubMed Central

    Mir, Shahnaz Ahmad; Masoodi, Shariq Rashid; Shafi, Shafia; Hameed, Iqra; Dar, Maqsood Ahmad; Bashir, Mir Iftikhar; Wani, Arshad Iqbal; Shah, Zaffar Amin; Parveen, Shameema; Zargar, Abdul Hamid; Shah, Parviz Ahmad

    2016-01-01

    Introduction: Pregnant women represent a typical group susceptible to dietary and mineral deficiencies. This study was sought to assess the efficacy and safety of various doses of 25-hydroxyvitamin D (25[OH]D) supplementation during pregnancy and ratify the inadequacy of the recommended daily allowance for Vitamin D in vulnerable groups. Materials and Methods: A total of 100 pregnant women were included in this open-label, parallel group, prospective, randomized, and controlled trial. Study subjects were assigned to four treatment groups: Group 1 (n = 26), 1000 IU of Vitamin D daily; Group 2 (n = 21), 30,000 IU of Vitamin D monthly; Group 3 (n = 27), 2000 IU of Vitamin D daily; and Group 4 (n = 26), 60,000 IU Vitamin D monthly. Group 1 and 2 were further analyzed together as Group 1K (1000 IU daily and 30,000 IU monthly), and Group 3 and 4 as Group 2K (2000 IU daily and 60,000 IU monthly). The analysis was done on an intention to treat basis. Results: A total of 87 patients completed the study; 21 in Group 1, 25 in Group 2, 18 in Group 3, and 23 in Group 4. The levels of 25(OH)D at baseline ranged from 1.3 to 58.0 with a mean of 24.2 ± 15.1 ng/ml. Postsupplementation, 25(OH)D levels ranged from 11.5 to 70.3 with a mean of 40.2 ± 12.2 ng/ml. The postsupplementation levels of 25(OH)D were higher in Group 2K (42.86 ± 12.83) than in Group 1K (36.96 ± 10.56) with P value of 0.023. Conclusion: We concluded that Vitamin D supplementation with 2000 IU/day or 60,000 IU/month is very effective and safe in achieving Vitamin D sufficiency in pregnant women. PMID:27186550

  6. Efficacy of Aloe Vera Supplementation on Prediabetes and Early Non-Treated Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Zhang, Yiyi; Liu, Wen; Liu, Dan; Zhao, Tieyun; Tian, Haoming

    2016-01-01

    The aim of this study was to evaluate evidence for the efficacy of aloe vera on managing prediabetes and early non-treated diabetes mellitus. We performed a systematic search of PubMed, Embase, and Cochrane Central Register of Controlled Trials until 28 January 2016. A total of five randomized controlled trials (RCTs) involving 415 participants were included. Compared with the controls, aloe vera supplementation significantly reduced the concentrations of fasting blood glucose (FBG) (p = 0.02; weighed mean difference [WMD]: −30.05 mg/dL; 95% confidence interval [CI]: −54.87 to −5.23 mg/dL), glycosylated hemoglobin A1c (HbA1c) (p < 0.00001; WMD: −0.41%; 95% CI: −0.55% to −0.27%), triglyceride (p = 0.0001), total cholesterol (TC) (p < 0.00001), and low density lipoprotein-cholesterol (LDL-C) (p < 0.00001). Aloe vera was superior to placebo in increasing serum high density lipoprotein-cholesterol (HDL-C) levels (p = 0.04). Only one adverse event was reported. The evidence from RCTs showed that aloe vera might effectively reduce the levels of FBG, HbA1c, triglyceride, TC and LDL-C, and increase the levels of HDL-C on prediabetes and early non-treated diabetic patients. Limited evidence exists about the safety of aloe vera. Given the small number and poor quality of RCTs included in the meta-analysis, these results are inconclusive. A large-scale, well-designed RCT is needed to further address this issue. PMID:27347994

  7. Efficacy of Aloe Vera Supplementation on Prediabetes and Early Non-Treated Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Zhang, Yiyi; Liu, Wen; Liu, Dan; Zhao, Tieyun; Tian, Haoming

    2016-01-01

    The aim of this study was to evaluate evidence for the efficacy of aloe vera on managing prediabetes and early non-treated diabetes mellitus. We performed a systematic search of PubMed, Embase, and Cochrane Central Register of Controlled Trials until 28 January 2016. A total of five randomized controlled trials (RCTs) involving 415 participants were included. Compared with the controls, aloe vera supplementation significantly reduced the concentrations of fasting blood glucose (FBG) (p = 0.02; weighed mean difference [WMD]: -30.05 mg/dL; 95% confidence interval [CI]: -54.87 to -5.23 mg/dL), glycosylated hemoglobin A1c (HbA1c) (p < 0.00001; WMD: -0.41%; 95% CI: -0.55% to -0.27%), triglyceride (p = 0.0001), total cholesterol (TC) (p < 0.00001), and low density lipoprotein-cholesterol (LDL-C) (p < 0.00001). Aloe vera was superior to placebo in increasing serum high density lipoprotein-cholesterol (HDL-C) levels (p = 0.04). Only one adverse event was reported. The evidence from RCTs showed that aloe vera might effectively reduce the levels of FBG, HbA1c, triglyceride, TC and LDL-C, and increase the levels of HDL-C on prediabetes and early non-treated diabetic patients. Limited evidence exists about the safety of aloe vera. Given the small number and poor quality of RCTs included in the meta-analysis, these results are inconclusive. A large-scale, well-designed RCT is needed to further address this issue. PMID:27347994

  8. Efficacy of mini VIDAS for the detection of Campylobacter spp. from retail broiler meat enriched in Bolton broth, with or without the supplementation of blood.

    PubMed

    Liu, Lin; Hussain, Syeda K; Miller, Robert S; Oyarzabal, Omar A

    2009-11-01

    The goals of this study were to evaluate the efficacy of the mini VIDAS automated immunoassay chemistry system to detect Campylobacter spp. from retail broiler meat enriched in Bolton broth supplemented with lysed blood (B+B) or without blood (B-B), and to detect positive samples at 24 versus 48 h after enrichment. Retail broiler meat was enriched and tested for Campylobacter spp. with the mini VIDAS and with an agar plate. Isolates were speciated with a multiplex PCR and typed with pulsed-field gel electrophoresis (PFGE) to evaluate relatedness of isolates collected from subsamples enriched in B+B or B-B. The number of Campylobacter-positive samples by mini VIDAS was similar (P > 0.05) to the results found with traditional plating media for naturally contaminated broiler meat, regardless of whether the comparison was made between B+B and B-B, or among different meat products (breast, tenders, and thighs). More positive samples were found at 48 h of enrichment than at 24 h of enrichment (P < 0.05). A Campylobacter jejuni:Campylobacter coli ratio of 4:1 was found in this study. Most of the isolates from both subsamples (B+B and B-B) were similar or identical by PFGE analysis, except for a few samples in which the PFGE profiles of the isolates from the subsamples were different. Mini VIDAS allowed for the detection of Campylobacter spp. within 48 h after enrichment. However, the sensitivity is similar to plate media, and retail broiler samples need to be enriched for 48 h to avoid false negatives. PMID:19903413

  9. Safety and efficacy of coenzyme Q10 supplementation in early chronic Peyronie's disease: a double-blind, placebo-controlled randomized study.

    PubMed

    Safarinejad, M R

    2010-01-01

    No oral medication has proved to be clearly beneficial for Peyronie's disease (PD). We investigated the safety and efficacy of coenzyme Q(10) (CoQ(10)) supplementation in patients with early chronic PD. We conducted a randomized clinical trial of 186 patients with chronic early PD. Patients were randomly assigned to either 300 mg CoQ(10) daily (n=93) or similar regimen of placebo (n=93) for 24 weeks. Erectile function (EF), pain during erection, plaque volume, penile curvature and treatment satisfaction using patient versions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire were assessed at baseline and every 4 weeks during study period. EF was assessed using International Index of Erectile Function (IIEF-5), and pain was evaluated with a visual analog scale (VAS, 0-10). All patients also responded to a Global Assessment Question, 'Has the treatment you have been taking during this study improved your erections?' After 24 weeks, mean IIEF-5 score, mean VAS score and mean EDITS score improved significantly in patients receiving CoQ(10) (all P<0.01). Mean plaque size and mean penile curvature degree were decreased in the CoQ(10) group, whereas a slight increase was noted in the placebo group (both P=0.001). Mean index of IIEF-5 in 24-week treatment period was 17.8 ± 2.7 in the CoQ(10) group and 8.8 ± 1.5 in the placebo group (P=0.001). Of the patients in CoQ(10) group, 11 (13.6%) had disease progression vs 46 (56.1%) in placebo group (P=0.01). In patients with early chronic PD, CoQ(10) therapy leads plaque size and penile curvature reduction and improves EF. PMID:20720560

  10. Omega-3 Fatty Acid Formulations in Cardiovascular Disease: Dietary Supplements are Not Substitutes for Prescription Products.

    PubMed

    Fialkow, Jonathan

    2016-08-01

    Omega-3 fatty acid products are available as prescription formulations (icosapent ethyl, omega-3-acid ethyl esters, omega-3-acid ethyl esters A, omega-3-carboxylic acids) and dietary supplements (predominantly fish oils). Most dietary supplements and all but one prescription formulation contain mixtures of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Products containing both EPA and DHA may raise low-density lipoprotein cholesterol (LDL-C). In clinical trials, the EPA-only prescription product, icosapent ethyl, did not raise LDL-C compared with placebo. To correct a common misconception, it is important to note that omega-3 fatty acid dietary supplements are not US FDA-approved over-the-counter drugs and are not required to demonstrate safety and efficacy prior to marketing. Conversely, prescription products are supported by extensive clinical safety and efficacy investigations required for FDA approval and have active and ongoing safety monitoring programs. While omega-3 fatty acid dietary supplements may have a place in the supplementation of diet, they generally contain lower levels of EPA and DHA than prescription products and are not approved or intended to treat disease. Perhaps due to the lack of regulation of dietary supplements, EPA and DHA levels may vary widely within and between brands, and products may also contain unwanted cholesterol or fats or potentially harmful components, including toxins and oxidized fatty acids. Accordingly, omega-3 fatty acid dietary supplements should not be substituted for prescription products. Similarly, prescription products containing DHA and EPA should not be substituted for the EPA-only prescription product, as DHA may raise LDL-C and thereby complicate the management of patients with dyslipidemia. PMID:27138439

  11. The efficacy of bait supplements for improving the rate of discovery of bait stations in the field by the formosan subterranean termite (Isoptera: Rhinotermitidae)

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Field tests of four different bait supplements were conducted in City Park, New Orleans, Louisiana. The four bait supplements tested included two different formulations of decayed material, a sports drink, and the combination of an application of an aqueous solution of Summon Preferred Food SourceTM...

  12. Dietary Supplements for Weight Loss

    MedlinePlus

    ... supplements, they won’t be listed on the product label and they could harm you. Weight-loss supplements can be sold without being tested or approved by the U.S. Food and Drug ... can recall that product. Visit this website to view the FDA’s public ...

  13. 29 CFR 1952.227 - Changes to approved plans.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Tennessee § 1952.227 Changes to approved plans. (a) Legislation. (1) On March 29, 1994, the Assistant Secretary approved Tennessee's revised..., the Assistant Secretary approved Tennessee's plan supplement, which is generally identical to...

  14. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. Link to... or effectiveness of the device for which the applicant has an approved PMA, unless the change is of...

  15. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Supplemental benefits. 422.102 Section 422.102... (CONTINUED) MEDICARE PROGRAM (CONTINUED) MEDICARE ADVANTAGE PROGRAM Benefits and Beneficiary Protections § 422.102 Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an...

  16. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 3 2011-10-01 2011-10-01 false Supplemental benefits. 422.102 Section 422.102... (CONTINUED) MEDICARE PROGRAM MEDICARE ADVANTAGE PROGRAM Benefits and Beneficiary Protections § 422.102 Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an MA organization...

  17. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Supplemental benefits. 422.102 Section 422.102... (CONTINUED) MEDICARE PROGRAM (CONTINUED) MEDICARE ADVANTAGE PROGRAM Benefits and Beneficiary Protections § 422.102 Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an...

  18. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Supplemental benefits. 422.102 Section 422.102... (CONTINUED) MEDICARE PROGRAM (CONTINUED) MEDICARE ADVANTAGE PROGRAM Benefits and Beneficiary Protections § 422.102 Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an...

  19. A Randomized, Double-blind, Placebo-controlled, Multi-center, Extension Trial Evaluating the Efficacy of a New Oral Supplement in Women with Self-perceived Thinning Hair

    PubMed Central

    Dayan, Steven

    2015-01-01

    Objective: The purpose of this six-month, randomized, double-blind, multi-center, placebo-controlled study was to determine if the administration of a new oral supplement will promote terminal hair growth. Design: A randomized, double-blind study. Setting: Two private practices (dermatology and facial plastics). Participants: Women 21 to 75 years of age with self-perceived thinning hair. Measurements: The primary efficacy endpoint was the change in terminal and vellus hairs in a 4cm2 target area of the scalp after 90 and 180 days of treatment. Secondary endpoints were change in hair diameter and responses to Quality of Life and Self-Assessment questionnaires. Results: Subjects treated with the new oral supplement achieved a significant increase in the number of baseline terminal hairs at 90 and 180 days (for each, p<0.0001, respectively) and were significantly greater then placebo (p<0.0001). Treatment with the new oral supplement was also associated with a significant increase in baseline terminal hair diameter after 90 (p=0.006) and 180 days of treatment (p=0.001) which was significantly greater than placebo at the end of the study (p=0.003). Improvements in hair growth and hair diameter were associated with significant improvement in most responses to Self-Assessment and Quality of Life Questionnaire responses. There were no adverse events. Conclusion: The daily administration of a new oral supplement was associated with significant increases in the number of terminal and vellus hairs and hair diameter. Most study participants believed the use of the oral supplement resulted in significant improvement in skin and hair quality and quality of life. PMID:26705444

  20. Evaluating the efficacy of three USDA-approved antimicrobial sprays for reducing surrogate Shiga toxin-producing cells of "Escherichia coli on bob veal carcasses

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Shiga toxin-producing Escherichia coli (STEC) have recently been recognized as a problem for the veal industry, suggesting the need for effective antimicrobial intervention strategies throughout processing. Therefore, we evaluated the efficacy of lactic acid (4.5%), Citrilow™ (pH 1.2), and Beefxide®...

  1. Brivaracetam: First Global Approval.

    PubMed

    Markham, Anthony

    2016-03-01

    Brivaracetam (Briviact(®)), a 4-n-propyl analogue of levetiracetam developed by UCB Pharma, has been approved in the EU as an adjunctive therapy for the treatment of partial-onset seizures. Brivaracetam binds to synaptic vesicle glycoprotein 2a (SV2A) in the brain with greater selectivity and 15- to 30-fold higher affinity than levetiracetam, as demonstrated in preclinical models, and has demonstrated efficacy in reducing the frequency of partial onset seizures in clinical trials. This article summarizes the milestones in the development of brivaracetam leading to this first approval for use as adjunctive therapy for uncontrolled partial-onset seizures in adults with epilepsy. PMID:26899665

  2. Folate/Folic Acid Knowledge, Intake, and Self-Efficacy of College-Aged Women: Impact of Text Messaging and Availability of a Folic Acid-Containing Supplement

    ERIC Educational Resources Information Center

    Rampersaud, Gail C.; Sokolow, Andrew; Gruspe, Abigail; Colee, James C.; Kauwell, Gail P. A.

    2016-01-01

    Objective: To evaluate the impact of educational text messages (TMs) on folate/folic acid knowledge and consumption among college-aged women, and to evaluate the impact of providing folic acid supplements on folate/folic acid intake among college-aged women. Participants: A total of 162 women (18-24 years) recruited from a university. Methods: The…

  3. Efficacy of Multivitamin/mineral Supplementation to Reduce Chronic Disease Risk: A Critical Review of the Evidence from Observational Studies and Randomized Controlled Trials.

    PubMed

    Angelo, Giana; Drake, Victoria J; Frei, Balz

    2015-01-01

    We reviewed recent scientific evidence regarding the effects of multivitamin/mineral (MVM) supplements on risk of chronic diseases, including cancer, cardiovascular disease, and age-related eye diseases. Data from randomized controlled trials (RCTs) and observational, prospective cohort studies were examined. The majority of scientific studies investigating the use of MVM supplements in chronic disease risk reduction reported no significant effect. However, the largest and longest RCT of MVM supplements conducted to date, the Physicians' Health Study II (PHS II), found a modest and significant reduction in total and epithelial cancer incidence in male physicians, consistent with the Supplémentation en Vitamines et Minéraux Antioxydants (SU.VI.MAX) trial. In addition, PHS II found a modest and significant reduction in the incidence of nuclear cataract, in agreement with several other RCTs and observational, prospective cohort studies. The effects of MVM use on other subtypes of cataract and age-related macular degeneration remain unclear. Neither RCTs nor prospective cohort studies are without their limitations. The placebo-controlled trial design of RCTs may be inadequate for nutrient interventions, and residual confounding, measurement error, and the possibility of reverse causality are inherent to any observational study. National surveys show that micronutrient inadequacies are widespread in the US and that dietary supplements, of which MVMs are the most common type, help fulfill micronutrient requirements in adults and children. PMID:24941429

  4. Efficacy of whey protein supplementation on resistance exercise-induced changes in muscle strength, lean mass, and function in mobility-limited older adults

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Whey protein supplementation may augment resistance exercise-induced increases in muscle strength and mass. Further studies are required to determine whether this effect extends to functionally compromised older adults. The objectives of the study were to compare the effects of whey protein concent...

  5. The Efficacy of Instructor-Guided Supplemental Instruction as a Strategy for Helping Reading-Deficient College Students Improve Testing and Assessment Outcomes

    ERIC Educational Resources Information Center

    Bartley-Lukula, Audrey

    2013-01-01

    This research project examined whether the use of Instructor-guided Supplemental Instruction as a classroom scaffolding technique, might help improve testing and assessment reading outcomes for reading-deficient college students. The study was completed at Tennessee State University in Nashville, Tennessee over the 16-week Fall, 2012 semester…

  6. The efficacy of micronutrient supplementation in reducing the prevalence of anaemia and deficiencies of zinc and iron among adolescents in Sri Lanka

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Objective: To determine the effectiveness of combined iron and zinc over the iron- or zinc-only supplementation in correcting deficiency and possible interactive effects in a group of adolescent school children. Subjects and methods: Schoolchildren (n=821) of 12–16 years of age were randomized into ...

  7. Ergogenic Aids and Supplements.

    PubMed

    Porrini, Marisa; Del Boʼ, Cristian

    2016-01-01

    Great interest is currently shown for the contribution of nutrition to optimize training and athletic performance, and a considerable debate exists about the potential ergogenic value of several dietary supplements. However, most of the products used by athletes do not provide sufficient scientific evidence regarding their efficacy in enhancing physical performance as well as their specificity of action and safety. For this reason, sport nutrition professionals need skills in evaluating the scientific value of papers and advertisements on ergogenic aids and supplements in order to support athletes in their choice. In the present chapter, the efficacy of some of the most popular supplements used by athletes and sport practitioners will be discussed. Particular attention will be devoted to amino acids and derivatives, caffeine and caffeinated energy drinks, and some antioxidants. PMID:27348226

  8. Antioxidative efficacy of parallel and combined supplementation with coenzyme Q10 and d-alpha-tocopherol in mildly hypercholesterolemic subjects: a randomized placebo-controlled clinical study.

    PubMed

    Kaikkonen, J; Nyyssönen, K; Tomasi, A; Iannone, A; Tuomainen, T P; Porkkala-Sarataho, E; Salonen, J T

    2000-09-01

    It has been claimed that coenzyme Q10 (Q10) would be an effective plasma antioxidant since it can regenerate plasma vitamin E. To test separate effects and interaction between Q10 and vitamin E in the change of plasma concentrations and in the antioxidative efficiency, we carried out a double-masked, double-blind clinical trial in 40 subjects with mild hypercholesterolemia undergoing statin treatment. Subjects were randomly allocated to parallel groups to receive either Q10 (200 mg daily), d-alpha-tocopherol (700 mg daily), both antioxidants or placebo for 3 months. In addition we investigated the pharmacokinetics of Q10 in a separate one-week substudy. In the group that received both antioxidants, the increase in plasma Q10 concentration was attenuated. Only vitamin E supplementation increased significantly the oxidation resistance of isolated LDL. Simultaneous Q10 supplementation did not increase this antioxidative effect of vitamin E. Q10 supplementation increased and vitamin E decreased significantly the proportion of ubiquinol of total Q10, an indication of plasma redox status in vivo. The supplementations used did not affect the redox status of plasma ascorbic acid. In conclusion, only vitamin E has antioxidative efficiency at high radical flux ex vivo. Attenuation of the proportion of plasma ubiquinol of total Q10 in the vitamin E group may represent in vivo evidence of the Q10-based regeneration of the tocopheryl radicals. In addition, Q10 might attenuate plasma lipid peroxidation in vivo, since there was an increased proportion of plasma ubiquinol of total Q10. PMID:10993487

  9. Efficacy of bait supplements for improving the rate of discovery of bait stations in the field by formosan subterranean termites (Isoptera: Rhinotermitidae).

    PubMed

    Cornelius, Mary L; Lyn, Margaret; Williams, Kelley S; Lovisa, Mary P; De Lucca, Anthony J; Lax, Alan R

    2009-06-01

    Field tests of four different bait supplements were conducted in City Park, New Orleans, LA. The four bait supplements tested included two different formulations of decayed material, a sports drink, and the combination of an application of an aqueous solution of Summon Preferred Food Source disks with the disk itself. Although all the bait supplements in this study resulted in a slightly greater number of treated stations discovered compared with control stations, only the application of the aqueous solution combined with the disk caused a significant increase in the number of stations discovered by termites. This treatment resulted in a significantly greater rate of discovery of treated stations versus control stations after only 14 d in the field. Termites were able to discover six times as many treated as control stations after 14 d, 9 times as many after 28 d, and 12 times as many after 42 d. These findings provide evidence that the diffusion of an aqueous solution into the soil underneath monitoring stations significantly decreased the length of time required for termites to infest stations. PMID:19610435

  10. PA02.15. Validation of ayurvedic concept of anthropometry and clinical evaluation of efficacy of “Suktyadi Yog” as a calcium supplementation in children

    PubMed Central

    Kumar, S Vinod; Kumar, N Rakesh

    2013-01-01

    Purpose: The present study aims to validate the ayurvedic anthropometical parameter for assessment of proper growth & devlopment and also to identify any disease linkage. For proper bony growth adequate calcium supplement is necessary. Evaluation of role of an ayurvedic compound containing calcium preparation needed therefore included in the second phase of the study. In calcium deficiency Ayurvedic Managment “Suktyadi Yog” may be useful. It is a rich source of calcium and have deepaniya drugs. Deepaniya drugs is useful for absorption of calcium. Method: Validations of Ayurvedic Sharir pramana on the basis of modern concept (Parameters) in children and Peer review journals were searched to list content of “Suktyadi yog” with calcium supplementation activities, particularly acting in calcium deficient and healthy children. Result: Result of the study show Sharir praman of children found almost equal to as explained in ayurvedic texts. Out of all research Sukti bhasma, Godanti bhasma, yasad bhasma and Trikatu was found potent to reduce Calcium deficiency. It is very cost effective, easily available with highest calcium supplementation properties. Conclusion: Calcium deficiency is a major problem in children and “Suktyadi yog” is a best option to reduce it.

  11. Chitinolytic Streptomyces vinaceusdrappus S5MW2 isolated from Chilika lake, India enhances plant growth and biocontrol efficacy through chitin supplementation against Rhizoctonia solani.

    PubMed

    Yandigeri, Mahesh S; Malviya, Nityanand; Solanki, Manoj Kumar; Shrivastava, Pooja; Sivakumar, G

    2015-08-01

    A chitinolytic actinomycete Streptomyces vinaceusdrappus S5MW2 was isolated from water sample of Chilika lake, India and identified using 16S rRNA gene sequencing. It showed in vitro antifungal activity against the sclerotia producing pathogen Rhizoctonia solani in a dual culture assay and by chitinase enzyme production in a chitin supplemented minimal broth. Moreover, isolate S5MW2 was further characterized for biocontrol (BC) and plant growth promoting features in a greenhouse experiment with or without colloidal chitin (CC). Results of greenhouse experiment showed that CC supplementation with S5MW2 showed a significant growth of tomato plants and superior disease reduction as compared to untreated control and without CC treated plants. Moreover, higher accumulation of chitinase also recovered in the CC supplemented plants. Significant effect of CC also concurred with the Analysis of Variance of greenhouse parameters. These results show that the a marine antagonist S5MW2 has BC efficiency against R. solani and chitinase enzyme played important role in plant resistance. PMID:25982747

  12. Narrative review of the safety and efficacy of marijuana for the treatment of commonly state-approved medical and psychiatric disorders.

    PubMed

    Belendiuk, Katherine A; Baldini, Lisa L; Bonn-Miller, Marcel O

    2015-01-01

    The present investigation aimed to provide an objective narrative review of the existing literature pertaining to the benefits and harms of marijuana use for the treatment of the most common medical and psychological conditions for which it has been allowed at the state level. Common medical conditions for which marijuana is allowed (i.e., those conditions shared by at least 80 percent of medical marijuana states) were identified as: Alzheimer's disease, amyotrophic lateral sclerosis, cachexia/wasting syndrome, cancer, Crohn's disease, epilepsy and seizures, glaucoma, hepatitis C virus, human immunodeficiency virus/acquired immunodeficiency syndrome, multiple sclerosis and muscle spasticity, severe and chronic pain, and severe nausea. Post-traumatic stress disorder was also included in the review, as it is the sole psychological disorder for which medical marijuana has been allowed. Studies for this narrative review were included based on a literature search in PsycINFO, MEDLINE, and Google Scholar. Findings indicate that, for the majority of these conditions, there is insufficient evidence to support the recommendation of medical marijuana at this time. A significant amount of rigorous research is needed to definitively ascertain the potential implications of marijuana for these conditions. It is important for such work to not only examine the effects of smoked marijuana preparations, but also to compare its safety, tolerability, and efficacy in relation to existing pharmacological treatments. PMID:25896576

  13. 29 CFR 1952.385 - Changes to approved plans.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Puerto Rico § 1952.385 Changes to... approved Puerto Rico's plan supplement, which is generally identical to the Federal Voluntary Protection... Program. (b) Legislation. (1) On March 29, 1994, the Assistant Secretary approved Puerto Rico's...

  14. Efficacy of Ascorbic Acid (Vitamin C) and/N-Acetylcysteine (NAC) Supplementation on Nutritional and Antioxidant Status of Male Chronic Obstructive Pulmonary Disease (COPD) Patients.

    PubMed

    Pirabbasi, Elham; Shahar, Suzana; Manaf, Zahara Abdul; Rajab, Nor Fadilah; Manap, Roslina Abdul

    2016-01-01

    Antioxidant therapy has a potential to be introduced as therapeutic modality for chronic obstructive pulmonary disease (COPD) patients. This study aimed to determine the effect of antioxidant supplementation [ascorbic acid and N-Acetylcysteine (NAC)] on nutritional and antioxidant status in male COPD patients. A parallel and single blind randomised controlled clinical trial (RCT) was conducted at two medical centers in Kuala Lumpur, Malaysia. Seventy-nine subjects were recruited and randomly divided into four trial arms (i.e., NAC, vitamin C, NAC+vitamin C and control groups) for six mo. The primary outcome was changes in body mass index by estimating power of 90% and significance level of p<0.05. Repeated Measure ANOVA showed that there was a significant interaction effect on BMI (p=0.046) and carbohydrate intake (p=0.030), especially in the NAC group. Plasma glutathione (GSH) increased significantly in all intervention groups, especially in vitamin C (p=0.005). A single supplementation of NAC or vitamin C improved nutritional and antioxidant status of subjects. PMID:27117852

  15. FDA-Approved Natural Polymers for Fast Dissolving Tablets.

    PubMed

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets. PMID:26556207

  16. FDA-Approved Natural Polymers for Fast Dissolving Tablets

    PubMed Central

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets. PMID:26556207

  17. Dietary Supplements

    MedlinePlus

    Dietary supplements are vitamins, minerals, herbs, and many other products. They can come as pills, capsules, powders, drinks, and energy bars. Supplements do not have to go through the testing that drugs do. Some ...

  18. Dietary Supplements

    MedlinePlus

    Dietary supplements are vitamins, minerals, herbs, and many other products. They can come as pills, capsules, powders, drinks, ... possible Tell your health care provider about any dietary supplements you use Do not take a bigger dose ...

  19. Safety and Efficacy of Banaba-Moringa oleifera-Green Coffee Bean Extracts and Vitamin D3 in a Sustained Release Weight Management Supplement.

    PubMed

    Stohs, Sidney J; Kaats, Gilbert R; Preuss, Harry G

    2016-04-01

    This 60-day, 30-subject pilot study examined a novel combination of ingredients in a unique sustained release (Carbopol matrix) tablet consumed twice daily. The product was composed of extracts of banaba leaf, green coffee bean, and Moringa oleifera leaf and vitamin D3. Safety was assessed using a 45-measurement blood chemistry panel, an 86-item self-reported Quality of Life Inventory, bone mineral density, and cardiovascular changes. Efficacy was assessed by calculating a body composition improvement index (BCI) based on changes in dual energy X-ray absorptiometry measured fat mass (FM) and fat-free mass (FFM) as well as between the study group (SG) and a historical placebo group. No changes occurred in any blood chemistry measurements. Positive changes were found in the Quality of Life (QOL) inventory composite scores. No adverse effects were observed. Decreases occurred in FM (p = 0.004) and increases in FFM (p = 0.009). Relative to the historical placebo group, the SG lost more FM (p < 0.0001), gained more FFM (p = <0.0001), and had a negative BCI of -2.7 lb. compared with a positive BCI in the SG of 3.4 lb., a 6.1 discordance (p = 0.0009). The data support the safety and efficacy of this unique product and demonstrate importance of using changes in body composition versus scale weight and BMI. PMID:26871553

  20. Evaluation of efficacy, safety and tolerability of high dose-intermittent calcitriol supplementation to advanced intrahepatic cholangiocarcinoma patients--a pilot study.

    PubMed

    Sookprasert, Aumkhae; Pugkhem, Ake; Khuntikeo, Narong; Chur-in, Siri; Chamadol, Nittaya; Prawan, Auemduan; Janeklang, Somkid; Vaeteewoottacharn, Kulthida; Kukongviriyapan, Veerapol; Pairojkul, Chawalit; Bhudhisawasdi, Vajarabhongsa; Wongkham, Sopit

    2012-01-01

    Antitumor activity (growth suppression) of vitamin D has been demonstrated using cholangiocarcinoma (CCA) cell lines, CCA cell-grafted animal models, and human CCA tissue cultures. The present study aimed to determine the toxicity and tolerability of intermittent-high dose calcitriol in advanced inoperable intrahepatic CCA patients and to evaluate the therapeutic efficacy of combinations of calcitriol and 5-fluorouracil-based chemotherapeutic drugs. The patients were divided into 3 groups: the first (n=2) received intermittent-high dose oral calcitriol 12 μg/day for 3 days, i.e. Monday-Wednesday, per week up to 3 months. The treatment did not cause any serious adverse events, except hypercalcemia grade I, once in 72 administrations. The second group (n=3) received chemotherapeutic drugs (5-fluorouracil, Mitomycin C and Leucovorin) for 3 cycles, one patient showing a partial response. The third group (n=4) received high dose calcitriol in combination with chemotherapeutic-drugs. All 4 patients encountered serious adverse events and two of them were withdrawn after the first drug cycle. This pilot study suggests that, although high dose-intermittent calcitriol appeared to be safe and tolerated well in advanced intrahepatic CCA patients, co-administration with 5-fluorouracil-based chemotherapeutic drugs caused unexpected potentiation of their toxicity. Adjustment of the doses of both drugs is required to avoid such toxicity and to optimize therapeutic efficacy of anticancer drugs when they were combined with high dose-intermittent calcitriol. PMID:23480759

  1. 7 CFR 1955.150 - State supplements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 14 2013-01-01 2013-01-01 false State supplements. 1955.150 Section 1955.150 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... CP must have prior approval of the National Office. Request for approval for those affecting MFH...

  2. 7 CFR 1955.150 - State supplements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 14 2014-01-01 2014-01-01 false State supplements. 1955.150 Section 1955.150 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... CP must have prior approval of the National Office. Request for approval for those affecting MFH...

  3. 7 CFR 1955.150 - State supplements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 14 2010-01-01 2009-01-01 true State supplements. 1955.150 Section 1955.150 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... CP must have prior approval of the National Office. Request for approval for those affecting MFH...

  4. 7 CFR 1955.150 - State supplements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 14 2011-01-01 2011-01-01 false State supplements. 1955.150 Section 1955.150 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... CP must have prior approval of the National Office. Request for approval for those affecting MFH...

  5. 7 CFR 1955.150 - State supplements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 14 2012-01-01 2012-01-01 false State supplements. 1955.150 Section 1955.150 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... CP must have prior approval of the National Office. Request for approval for those affecting MFH...

  6. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. (a... before making a change affecting the safety or effectiveness of the device for which the applicant has...

  7. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. (a... before making a change affecting the safety or effectiveness of the device for which the applicant has...

  8. Efficacy of Cistanche Tubulosa and Laminaria Japonica Extracts (MK-R7) Supplement in Preventing Patterned Hair Loss and Promoting Scalp Health

    PubMed Central

    Seok, Joon; Kim, Tae Su; Kwon, Hyun Jung; Lee, Sung Pyo; Kang, Myung Hwa; Kim, Myeung Nam

    2015-01-01

    Cistanche tubulosa and Laminaria japonica have been reported to have anti-oxidative, anticoagulant, anti-cancer and anti-inflammatory properties. They are expected to be a promising candidates for promoting hair growth and treating dandruff and scalp inflammation as a consequence. In this double-blinded, placebo-controlled clinical trial, we investigated the efficacy of Cistanche tubulosa extract and Laminaria japonica extract complex (MK-R7) in promoting hair health in patients with mild to moderate patterned hair loss. Using phototrichogram (Folliscope 4.0, LeadM, Seoul, Korea), we compared the density and diameter of hairs in patients receiving a placebo or Cistanche tubulosa extract and Laminaria japonica extract complex (MK-R7) at baseline, 8 and 16 weeks of the study. In order to determine the efficacy of treatment on dandruff and scalp inflammation, investigator's assessment score and patient's subjective score were also performed. We found a statistically significant increase in the hair density of the test group (n = 45, MK-R7 400 mg) after 16 weeks of consuming the MK-R7 (test group: 23.29 n/cm2 ± 24.26, control: 10.35 n/cm2 ± 20.08, p < 0.05). In addition, we found a statistically significant increase in hair diameter in the test group compared to control group at week 16 (test group: 0.018 mm ± 0.015, control: 0.003 mm ± 0.013, p < 0.05). There were also significant outcomes regarding the investigator's visual assessment and patient's subjective score of dandruff and scalp inflammation in the test group compared to those in control group. Based on the results of this clinical study, we conclude that Cistanche tubulosa extract and Laminaria japonica extract complex (MK-R7) are promising substances for promoting health of the scalp and hair. PMID:25954733

  9. The efficacy of vitamin C supplementation on reducing total serum cholesterol in human subjects: a review and analysis of 51 experimental trials

    PubMed Central

    McRae, Marc P.

    2006-01-01

    Abstract Objective Observational studies in humans have shown an inverse relationship between plasma vitamin C concentration and total serum cholesterol. However, experimental studies have shown inconsistent results regarding the ability of vitamin C to reduce total serum cholesterol. Methods Published reports of trials studying the effects of vitamin C on serum lipids were identified by a search of Medline from 1966 to 2004. Data from 51 experimental studies comprising of 1666 pooled subjects were selected for analysis. Results A very strong negative association was observed between baseline total serum cholesterol and the percent change in cholesterol (r = −0.585, p<0.001). When subjects were divided into 4 groups based on their baseline total serum cholesterol levels, the following weighted mean percent changes in cholesterol from baseline were observed: normal cholesterol (<199mg/dl): 0.91±6.8% (n=508); borderline high cholesterol (200–239mg/dl): 3.90±5.78% (n=605); high cholesterol (240–279mg/dl): 11.40±7.96% (n=300); severe cholesterol (>280mg/dl): 14.30±8.36% (n=253). A significant inverse relationship was found between the baseline plasma vitamin C concentrations and mean percent change in total cholesterol from baseline (r = −0.500, p<0.005). It was also observed that the high and severe baseline cholesterol groups possessed lower baseline plasma vitamin C concentrations than those in the normal cholesterol groups (0.79 and 0.55 versus 1.24 mg/dl respectively). Conclusion This finding strengthens the hypothesis that the cholesterol lowering and cardio-protective benefit of vitamin C supplementation may be in its ability to elevate plasma vitamin C concentrations in those patients who initially possess lower than normal vitamin C plasma concentrations. PMID:19674666

  10. Chronic Supplementation of Curcumin Enhances the Efficacy of Antidepressants in Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.

    PubMed

    Yu, Jing-Jie; Pei, Liu-Bao; Zhang, Yong; Wen, Zi-Yu; Yang, Jian-Li

    2015-08-01

    Major depressive disorder is a devastating mental illness leading to a lifetime prevalence of higher than 16% on individuals. The treatment delay and inevitable adverse effects are major limitations of current depression interventions. Emerging evidence indicates that curcumin produced significant antidepressant properties in depression in both rodents and humans without adverse effects. Therefore, it is necessary to further clarify the antidepressant actions of curcumin and the underlying mechanism in depressed patients. A total of 108 male adults aged between 31 and 59 years were systematically recruited in Tianjin Anding Hospital. Subjects were administered the Chinese version of 17-item Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale that measures different scores of depressive symptoms. The subjects were asked to take 2 capsules containing either 1000 mg of curcumin or placebo soybean powder daily for 6 weeks on the basis of their current antidepressant medications. The plasma levels of interleukin 1β, tumor necrosis factor α, brain-derived neurotrophic factor, and salivary cortisol were measured by enzyme-linked immunosorbent assay before and after curcumin or placebo treatment during the 6-week procedure. Chronic supplementation with curcumin produced significant antidepressant behavioral response in depressed patients by reduction of 17-item Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale scores. Furthermore, curcumin decreases inflammatory cytokines interleukin 1β and tumor necrosis factor α level, increases plasma brain-derived neurotrophic factor levels, and decreases salivary cortisol concentrations compared with placebo group. These findings indicate the potential benefits of further implications of supplementary administration of curcumin to reverse the development of depression and enhance the outcome of antidepressants treatment in major depressive disorder. PMID:26066335

  11. Efficacy of Resveratrol Supplementation against Non-Alcoholic Fatty Liver Disease: A Meta-Analysis of Placebo-Controlled Clinical Trials.

    PubMed

    Zhang, Chongyang; Yuan, Weigang; Fang, Jianguo; Wang, Wenqing; He, Pei; Lei, Jiahui; Wang, Chunxu

    2016-01-01

    Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease with rising prevalence. Increasing evidence has demonstrated that resveratrol, a dietary phytochemical, is capable of attenuating NAFLD development and progression; however, results from clinical studies are inconsistent and inconclusive. Here, we conducted a meta-analysis to evaluate the efficacy of resveratrol on NAFLD, using several parameters to provide new insights for clinical application. We systematically searched EMBASE, PubMed, Science Citation Index, Elsevier, and Cochrane Library databases for studies published up to date (July 2016), in English, to identify and screen eligible, relevant studies. Either a fixed-effect model or random model was used to estimate mean difference (MD) and 95% confidence intervals (CIs) for the effect of resveratrol on NAFLD. Four randomized, double-blinded, placebo-controlled trials involving 156 patients were included in the meta-analysis. Levels of low-density lipoprotein (MD = 0.47, 95% CI: 0.21, 0.74, P < 0.05) and total cholesterol (MD = 0.49, 95% CI: 0.18, 0.80, P < 0.05) were higher in the resveratrol treatment groups than in placebo control groups, whereas other parameters were not altered. Overall, this study indicates that resveratrol treatment has negligible effects on attenuating NAFLD, given the small improvement in NAFLD features. More high-quality clinical trials of resveratrol for NAFLD are required to confirm these results. PMID:27560482

  12. Efficacy of Resveratrol Supplementation against Non-Alcoholic Fatty Liver Disease: A Meta-Analysis of Placebo-Controlled Clinical Trials

    PubMed Central

    Fang, Jianguo; Wang, Wenqing; He, Pei; Lei, Jiahui; Wang, Chunxu

    2016-01-01

    Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease with rising prevalence. Increasing evidence has demonstrated that resveratrol, a dietary phytochemical, is capable of attenuating NAFLD development and progression; however, results from clinical studies are inconsistent and inconclusive. Here, we conducted a meta-analysis to evaluate the efficacy of resveratrol on NAFLD, using several parameters to provide new insights for clinical application. We systematically searched EMBASE, PubMed, Science Citation Index, Elsevier, and Cochrane Library databases for studies published up to date (July 2016), in English, to identify and screen eligible, relevant studies. Either a fixed-effect model or random model was used to estimate mean difference (MD) and 95% confidence intervals (CIs) for the effect of resveratrol on NAFLD. Four randomized, double-blinded, placebo-controlled trials involving 156 patients were included in the meta-analysis. Levels of low-density lipoprotein (MD = 0.47, 95% CI: 0.21, 0.74, P < 0.05) and total cholesterol (MD = 0.49, 95% CI: 0.18, 0.80, P < 0.05) were higher in the resveratrol treatment groups than in placebo control groups, whereas other parameters were not altered. Overall, this study indicates that resveratrol treatment has negligible effects on attenuating NAFLD, given the small improvement in NAFLD features. More high-quality clinical trials of resveratrol for NAFLD are required to confirm these results. PMID:27560482

  13. A randomized controlled study of the efficacy of six-month supplementation with concentrated fish oil rich in omega-3 polyunsaturated fatty acids in first episode schizophrenia.

    PubMed

    Pawełczyk, Tomasz; Grancow-Grabka, Marta; Kotlicka-Antczak, Magdalena; Trafalska, Elżbieta; Pawełczyk, Agnieszka

    2016-02-01

    Short-term clinical trials of omega-3 polyunsaturated fatty acids (n-3 PUFA) as add-on therapy in patients with schizophrenia revealed mixed results. The majority of these studies used an 8- to 12-week intervention based on ethyl-eicosapentaenoic acid. A randomized placebo-controlled trial was designed to compare the efficacy of 26-week intervention, composed of either 2.2 g/day of n-3 PUFA, or olive oil placebo, with regard to symptom severity in first-episode schizophrenia patients. Seventy-one patients (aged 16-35) were enrolled in the study and randomly assigned to the study arms. The primary outcome measure of the clinical evaluation was schizophrenia symptom severity change measured by the Positive and Negative Syndrome Scale (PANSS). Mixed models repeated measures analysis revealed significant differences between the study arms regarding total PANSS score change favouring n-3 PUFA (p = 0.016; effect size (ES) = 0.29). A fifty-percent improvement in symptom severity was achieved significantly more frequently in the n-3 PUFA group than in the placebo group (69.4 vs 40.0%; p = 0.017). N-3 PUFA intervention was also associated with an improvement in general psychopathology, measured by means of PANSS (p = 0.009; ES = 0.32), depressive symptoms (p = 0.006; ES = 0.34), the level of functioning (p = 0.01; ES = 0.31) and clinical global impression (p = 0.046; ES = 0.29). The findings suggest that 6-month intervention with n-3 PUFA may be a valuable add-on therapy able to decrease the intensity of symptoms and improve the level of functioning in first-episode schizophrenia patients. PMID:26679763

  14. Obiltoxaximab: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-05-01

    Obiltoxaximab (Anthim(®), ETI-204) is a monoclonal antibody that is being developed by Elusys Therapeutics and the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority for the prevention and treatment of inhalational anthrax due to Bacillus anthracis. Obiltoxaximab has been designed to neutralize the free protective antigen of B. anthracis, thereby inhibiting the lethal effects of anthrax toxins. In March 2016, intravenous obiltoxaximab was approved in the USA for the treatment (in combination with appropriate antibacterial drugs) and prophylaxis of inhalational anthrax. Obiltoxaximab is being developed under the US FDA Animal Rule, in which marketing approval is based on its efficacy in relevant animal models and safety in phase I studies in healthy human volunteers. An intramuscular formulation of obiltoxaximab has also been evaluated in animal studies and a phase I study in healthy human volunteers. This article summarizes the milestones in the development of obiltoxaximab leading to this first approval for the treatment and prevention of inhalation anthrax. PMID:27085536

  15. Efficacy of a supplemental candy coproduct as an alternative carbohydrate source to lactose on growth performance of newly weaned pigs in a commercial farm condition.

    PubMed

    Guo, J Y; Phillips, C E; Coffey, M T; Kim, S W

    2015-11-01

    The experiment investigated the effects of a supplemental candy coproduct (Chocolate Candy Feed [CCF]; International Ingredient Corp., St. Louis, MO), an alternative carbohydrate source to dietary lactose, on growth performance and on health status of nursery pigs. Crossbred pigs ( = 1,408; 21 d of age and 7.1 ± 0.3 kg BW; Smithfield Premium Genetics, Rose Hill, NC) were randomly assigned to 4 treatments (16 pens/treatment and 22 pigs/pen) in a randomized complete block design: 0, 15, 30, and 45% of lactose replaced by CCF based on equal amounts of total sugars. The experimental period was divided into 3 phases: phase I (1.8 kg diet/pig for 11 ± 1 d), phase II (6.8 kg diet/pig for 17 ± 2 d), and phase III (until 49 d after weaning). Pigs received a common phase III diet. The levels of lactose, supplied by whey permeate (79.3 ± 0.8% lactose), were 20, 8, and 0% in phase I, II, and III, respectively. All experimental diets contained the same levels of essential AA and energy (ME) for each phase. Fecal scores were observed on d 5, 7, and 9 after weaning. Blood samples were taken at the end of phase I and II to measure blood urea N. The duration of phase I tended to linearly decrease ( = 0.063) with increasing CCF. In phase I, the ADFI increased ( < 0.05) with increasing CCF whereas ADG and G:F did not change. In phase II, the duration and ADFI did not change whereas ADG linearly decreased ( < 0.05) with increasing CCF. However, the G:F was not changed as CCF increased. During phase I and II together, the duration was linearly decreased ( < 0.05) as CCF increased, whereas no difference in growth performance was observed. Overall, ADFI, ADG, and G:F were not affected by replacing whey permeate with CCF in diets, indicating no adverse effects of a candy coproduct as a carbohydrate substitute to lactose on growth performance of nursery pigs. Blood urea N did not change in phase I but tended to linearly increase ( = 0.088) in phase II as CCF increased. There were no

  16. Effect of vitamin D supplementation on inflammation: protocol for a systematic review

    PubMed Central

    Mousa, Aya; Misso, Marie; Teede, Helena; Scragg, Robert; de Courten, Barbora

    2016-01-01

    Introduction The extraskeletal role of vitamin D is being increasingly recognised. This has important clinical implications, as vitamin D deficiency has reached epidemic proportions worldwide. Vitamin D has proposed anti-inflammatory properties, yet the role of vitamin D supplementation in reducing inflammation remains largely unknown. The purpose of this review is to investigate the impact of vitamin D supplementation on inflammation, and to identify relevant knowledge gaps in the field. Methods and analysis Medline, CINAHL, EMBASE and All EBM will be systematically searched for randomised controlled trials (RCTs) and systematic reviews of RCTs, comparing vitamin D supplementation with placebo, usual care or other pharmacological or non-pharmacological interventions. One reviewer will assess articles for eligibility according to prespecified selection criteria, after which 2 independent reviewers will perform data extraction and quality appraisal. Meta-analyses will be conducted where appropriate. Ethics and dissemination Formal ethical approval is not required as no primary data is collected. This systematic review will identify potential clinical implications of vitamin D deficiency and supplementation, and will be disseminated through a peer-reviewed publication and at conference meetings, to inform future research on the efficacy of vitamin D supplementation for inflammation and inflammatory diseases. PROSPERO registration number CRD42016037104. PMID:27048637

  17. Dietary supplements.

    PubMed

    Maughan, Ron J; King, Doug S; Lea, Trevor

    2004-01-01

    For the athlete training hard, nutritional supplements are often seen as promoting adaptations to training, allowing more consistent and intensive training by promoting recovery between training sessions, reducing interruptions to training because of illness or injury, and enhancing competitive performance. Surveys show that the prevalence of supplement use is widespread among sportsmen and women, but the use of few of these products is supported by a sound research base and some may even be harmful to the athlete. Special sports foods, including energy bars and sports drinks, have a real role to play, and some protein supplements and meal replacements may also be useful in some circumstances. Where there is a demonstrated deficiency of an essential nutrient, an increased intake from food or from supplementation may help, but many athletes ignore the need for caution in supplement use and take supplements in doses that are not necessary or may even be harmful. Some supplements do offer the prospect of improved performance; these include creatine, caffeine, bicarbonate and, perhaps, a very few others. There is no evidence that prohormones such as androstenedione are effective in enhancing muscle mass or strength, and these prohormones may result in negative health consequences, as well as positive drug tests. Contamination of supplements that may cause an athlete to fail a doping test is widespread. PMID:14971436

  18. Dietary Supplements and Sports Performance: Herbals

    PubMed Central

    Williams, Melvin

    2006-01-01

    This is the fourth in a series of six articles to discuss the major classes of dietary supplements (vitamins; minerals; amino acids; herbs or botanicals; metabolites, constituents/extracts, or combinations). The major focus is on efficacy of such dietary supplements to enhance exercise or sport performance. PMID:18500959

  19. 78 FR 44092 - Agency Information Collection Activities; Proposed Collection; Comment Request: Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... Food and Nutrition Service Agency Information Collection Activities; Proposed Collection; Comment Request: Supplemental Nutrition Assistance Program: State Agency Options AGENCY: Food and Nutrition... is a revision ] of the currently approved burden for the Supplemental Nutrition Assistance...

  20. 76 FR 35424 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... Regulation Supplement; Acquisition of Information Technology AGENCY: Defense Acquisition Regulations System... technology. The Office of Management and Budget (OMB) has approved this information collection requirement... Supplement (DFARS) Part 239, Acquisition of Information Technology, and the associated clauses at DFARS...

  1. 76 FR 33027 - Agency Information Collection (Supplemental Income Questionnaire (For Philippine Claims Only...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-07

    ... AFFAIRS Agency Information Collection (Supplemental Income Questionnaire (For Philippine Claims Only.... 2900-0668.'' SUPPLEMENTARY INFORMATION: Title: Supplemental Income Questionnaire (For Philippine Claims... approved collection. Abstract: Claimants residing in the Philippines complete VA Form 21-0784 to...

  2. Biofortified orange maize is as efficacious as a vitamin A supplement in Zambian children even in the presence of high liver reserves of vitamin A: a community-based, randomized placebo-controlled trial123456

    PubMed Central

    Gannon, Bryan; Kaliwile, Chisela; Arscott, Sara A; Schmaelzle, Samantha; Chileshe, Justin; Kalungwana, Ngándwe; Mosonda, Mofu; Pixley, Kevin; Masi, Cassim; Tanumihardjo, Sherry A

    2014-01-01

    Background: Biofortification is a strategy to relieve vitamin A (VA) deficiency. Biofortified maize contains enhanced provitamin A concentrations and has been bioefficacious in animal and small human studies. Objective: The study sought to determine changes in total body reserves (TBRs) of vitamin A with consumption of biofortified maize. Design: A randomized, placebo-controlled biofortified maize efficacy trial was conducted in 140 rural Zambian children. The paired 13C-retinol isotope dilution test, a sensitive biomarker for VA status, was used to measure TBRs before and after a 90-d intervention. Treatments were white maize with placebo oil (VA−), orange maize with placebo (orange), and white maize with VA in oil [400 μg retinol activity equivalents (RAEs) in 214 μL daily] (VA+). Results: In total, 133 children completed the trial and were analyzed for TBRs (n = 44 or 45/group). Change in TBR residuals were not normally distributed (P < 0.0001); median changes (95% CI) were as follows: VA−, 13 (−19, 44) μmol; orange, 84 (21, 146) μmol; and VA+, 98 (24, 171) μmol. Nonparametric analysis showed no statistical difference between VA+ and orange (P = 0.34); both were higher than VA− (P = 0.0034). Median (95% CI) calculated liver reserves at baseline were 1.04 (0.97, 1.12) μmol/g liver, with 59% >1 μmol/g, the subtoxicity cutoff; none were <0.1 μmol/g, the deficiency cutoff. The calculated bioconversion factor was 10.4 μg β-carotene equivalents/1 μg retinol by using the middle 3 quintiles of change in TBRs from each group. Serum retinol did not change in response to intervention (P = 0.16) but was reduced with elevated C-reactive protein (P = 0.0029) and α-1-acid glycoprotein (P = 0.0023) at baseline. Conclusions: β-Carotene from maize was efficacious when consumed as a staple food in this population and could avoid the potential for hypervitaminosis A that was observed with the use of preformed VA from supplementation and fortification. Use of

  3. Nutritional supplements for the treatment of ADHD.

    PubMed

    Bloch, Michael H; Mulqueen, Jilian

    2014-10-01

    Polyunsaturated fatty acid supplementation appears to have modest benefit for improving ADHD symptoms. Melatonin appears to be effective in treating chronic insomnia in children with ADHD but appears to have minimal effects in reducing core ADHD symptoms. Many other natural supplements are widely used in the United States despite minimal evidence of efficacy and possible side effects. This review synthesizes and evaluates the scientific evidence regarding the potential efficacy and side effects of natural supplements and herbal remedies for ADHD. We provide clinicians with recommendations regarding their potential use and role in overall ADHD treatment. PMID:25220092

  4. Calcium supplements

    MedlinePlus

    ... TYPES OF CALCIUM SUPPLEMENTS Forms of calcium include: Calcium carbonate: Over-the-counter (OTC) antacid products, such as Tums and Rolaids, contain calcium carbonate. These sources of calcium do not cost much. ...

  5. Dietary Supplements

    MedlinePlus

    ... are not intended to treat, diagnose, prevent, or cure diseases. Do not take supplements instead of your ... Partners Women's Health Topics Mammography Women and Diabetes HPV, HIV, Birth Control Heart Health for Women Pregnancy ...

  6. Nepali Supplements.

    ERIC Educational Resources Information Center

    Peace Corps, Washington, DC.

    This volume is intended as a supplement to Nepali language instruction. It contains songs, numerals, dialogues in Devanagari script, a Nepali-English, English-Nepali glossary, and an English-Nepali surveyor technical glossary. (AM)

  7. Dietary Supplements

    MedlinePlus

    ... take these supplements off the market. The Federal Trade Commission looks into reports of ads that might ... 504-5414 http://fnic.nal.usda.gov Federal Trade Commission 600 Pennsylvania Avenue, NW Washington, DC 20580 ...

  8. 5 CFR 7601.102 - Prior approval of outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... prohibited by statute or Federal regulation, including 5 CFR part 2635. (c) Scope of approval. Approval will.... 7601.102 Section 7601.102 Administrative Personnel NATIONAL ARCHIVES AND RECORDS ADMINISTRATION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ARCHIVES AND RECORDS...

  9. 46 CFR 221.13 - General approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... consistent with the requirements of 46 CFR parts 252 and 294, this approval excludes and does not apply to... listed by the Department of Commerce in 15 CFR part 740, Supplement 1, Country Group E, unless such..., Charter, delivery, or any other manner of Transfer to a Noncitizen of an interest in or control of...

  10. 7 CFR 1717.901 - Early approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Early approval. 1717.901 Section 1717.901 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE POST-LOAN POLICIES AND PROCEDURES COMMON TO INSURED AND GUARANTEED ELECTRIC LOANS Lien Accommodations for Supplemental Financing Required...

  11. 78 FR 20856 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Redesignation of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ...EPA is issuing a supplement to its proposed approval of the State of Indiana's request to redesignate the Indianapolis area to attainment for the 1997 annual National Ambient Air Quality Standards (NAAQS or standard) for fine particulate matter (PM2.5). This supplemental proposal revises and expands the basis for proposing approval of the state's request, in light of developments......

  12. 75 FR 16387 - Approval and Promulgation of Air Quality Implementation Plan: Kentucky; Approval Section 110(a)(1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ...EPA is announcing a limited 30-day reopening of the public comment period for the proposed rule entitled ``Approval and Promulgation of Air Quality Implementation Plan: Kentucky; Approval Section 110(a)(1) Maintenance Plan for the 1997 8-Hour Ozone Standard for the Owensboro Area,'' for the purpose of limited public review and comment on supplemental information that was provided by the......

  13. Dietary supplement drug therapies for depression.

    PubMed

    Howland, Robert H

    2012-06-01

    Many dietary supplements are readily accessible and commonly used for the treatment of depression. A dietary supplement is a product intended to supplement the diet but is not intended to treat, diagnose, prevent, or cure disease. The U.S. Food and Drug Administration can take action against dietary supplement manufacturers for products only after they are marketed, mainly if the product is found to be unsafe or if false or misleading claims are made about the product. Few dietary supplement products have been adequately studied for their safety and efficacy. Of the five products reviewed in this article (L-methylfolate, S-adenosyl-L-methionine [SAM-e], omega-3 fatty acids, L-tryptophan, and inositol), only omega-3 fatty acids and SAM-e have sufficient supporting evidence for their efficacy to warrant safe use. PMID:22589230

  14. Weight Loss Nutritional Supplements

    NASA Astrophysics Data System (ADS)

    Eckerson, Joan M.

    Obesity has reached what may be considered epidemic proportions in the United States, not only for adults but for children. Because of the medical implications and health care costs associated with obesity, as well as the negative social and psychological impacts, many individuals turn to nonprescription nutritional weight loss supplements hoping for a quick fix, and the weight loss industry has responded by offering a variety of products that generates billions of dollars each year in sales. Most nutritional weight loss supplements are purported to work by increasing energy expenditure, modulating carbohydrate or fat metabolism, increasing satiety, inducing diuresis, or blocking fat absorption. To review the literally hundreds of nutritional weight loss supplements available on the market today is well beyond the scope of this chapter. Therefore, several of the most commonly used supplements were selected for critical review, and practical recommendations are provided based on the findings of well controlled, randomized clinical trials that examined their efficacy. In most cases, the nutritional supplements reviewed either elicited no meaningful effect or resulted in changes in body weight and composition that are similar to what occurs through a restricted diet and exercise program. Although there is some evidence to suggest that herbal forms of ephedrine, such as ma huang, combined with caffeine or caffeine and aspirin (i.e., ECA stack) is effective for inducing moderate weight loss in overweight adults, because of the recent ban on ephedra manufacturers must now use ephedra-free ingredients, such as bitter orange, which do not appear to be as effective. The dietary fiber, glucomannan, also appears to hold some promise as a possible treatment for weight loss, but other related forms of dietary fiber, including guar gum and psyllium, are ineffective.

  15. Drugs Approved for Leukemia

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Leukemia This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Acute Lymphoblastic Leukemia (ALL) Abitrexate (Methotrexate) Arranon (Nelarabine) Asparaginase Erwinia chrysanthemi ...

  16. Glutamine supplementation.

    PubMed

    Wernerman, Jan

    2011-01-01

    Intravenous glutamine supplementation is standard care when parenteral nutrition is given for critical illness. There are data of a reduced mortality when glutamine supplementation is given. In addition, standard commercial products for parenteral nutrition do not contain any glutamine due to glutamine instability in aqueous solutions. For the majority of critical ill patients who are fed enterally, the available evidence is insufficient to recommend glutamine supplementation. Standard formulation of enteral nutrition contains some glutamine: 2-4 g/L. However, this dose is insufficient to normalize glutamine plasma concentration.Plasma concentration of glutamine is low in many patients with critical illness and a low level is an independent risk factor for mortality. A low plasma glutamine concentration is the best indicator of glutamine depletion. Data are emerging about how the endogenous production of glutamine is regulated. We know that skeletal muscle is the major producer of glutamine and that a part of the profound depletion of skeletal muscle seen in critical illness is a reflection of the need to produce glutamine.Glutamine is utilized in rapidly dividing cells in the splanchnic area. Quantitatively most glutamine is oxidized, but the availability of glutamine in surplus is important for the de novo synthesis of nucleotides and necessary for cell division and protein synthesis. More knowledge about the regulation of the endogenous production of glutamine is needed to outline better guidelines for glutamine supplementation in the future. PMID:21906372

  17. Sports Supplements

    MedlinePlus

    ... specialist. The doc will be able to offer alternatives to supplements based on your body and sport. Reviewed by: Mary L. Gavin, MD Date reviewed: January 2015 previous 1 • 2 • 3 For Teens For Kids For Parents MORE ON THIS TOPIC Sports Center Energy Drinks and Food Bars: Power or Hype? A ...

  18. Calcium supplements

    MedlinePlus

    ... SHOULD TAKE CALCIUM SUPPLEMENTS? Calcium is an important mineral for the human body. It helps build and protect your teeth ... absorb calcium. You can get vitamin D from sunlight exposure to your skin and from your diet. Ask your provider whether ...

  19. Supplemental Educational Services: An Action Science Research Study of Achieving State Standards for Provider Effectiveness

    ERIC Educational Resources Information Center

    McClintock, Cynthia Collette

    2012-01-01

    Supplemental educational services are designed to contribute tremendous support to local school districts and communities through state-approved provider programs. The state, however, prior to approving supplemental educational services provider programs, must utilize all available resources to assist in the process of screening and approving…

  20. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... environmental review or for which an environmental assessment or EIS has not been approved by the Fund. The... 12 Banks and Banking 9 2012-01-01 2012-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated...

  1. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... environmental review or for which an environmental assessment or EIS has not been approved by the Fund. The... 12 Banks and Banking 7 2011-01-01 2011-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated...

  2. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... environmental review or for which an environmental assessment or EIS has not been approved by the Fund. The... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated...

  3. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... environmental review or for which an environmental assessment or EIS has not been approved by the Fund. The... 12 Banks and Banking 9 2013-01-01 2013-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated...

  4. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... environmental review or for which an environmental assessment or EIS has not been approved by the Fund. The... 12 Banks and Banking 10 2014-01-01 2014-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated...

  5. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  6. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  7. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  8. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  9. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  10. Supplemental Training and Employment Programs (STEP) Handbook.

    ERIC Educational Resources Information Center

    Manpower Administration (DOL), Washington, DC.

    The handbook provides a thorough description of the philosophy and operating instructions of the Supplemental Training and Employment Program (STEP). It includes the background; purpose and description; sponsorship; project development, review, approval and funding; project duration; eligibility requirements; length of enrollment; participant…

  11. Evidence for supplemental treatments in androgenetic alopecia.

    PubMed

    Famenini, Shannon; Goh, Carolyn

    2014-07-01

    Currently, topical minoxidil and finasteride are the only treatments that have been FDA approved for the treatment of female pattern hair loss and androgenetic alopecia. Given the incomplete efficacy and sife effect profile of these medications, some patients utilize alternative treatments to help improve this condition. In this review, we illustrate the scientific evidence underlying the efficacy of these alternative approaches, including biotin, caffeine, melatonin, a marine extract, and zinc. PMID:25007363

  12. Biosimilars approval process.

    PubMed

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

    For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier. PMID:19925842

  13. Do dietary supplements help promote weight loss?

    PubMed

    Bell, Stacey J; Van Ausdal, Wendy; Grochoski, Greg

    2009-01-01

    As two-thirds of the US population is overweight or obese, new strategies are needed to help individuals safely and effectively lose weight. One option is to use dietary supplements, but not all supplements that are touted for weight loss have published clinical support for efficacy. The purpose of this article was to identify all published articles on dietary supplements for weight loss. Effectiveness of these supplements was defined as promoting 1-2 lb of weight loss each week. Although several dozen different dietary supplements are sold, only 14 published studies were identified. Four individual ingredients and three blends of ingredients were considered to be effective. Additionally, we compared weight loss from these dietary supplements to over-the-counter (OTC) orlistat (alli™, GlaxoSmithKline, Brentford, UK). Five single ingredients and three blends of ingredients produced more weight loss than OTC orlistat. Persons who use dietary supplements for weight management, counsel patients on how to lose weight, and retailers who sell dietary supplements, should become familiar with those supplements only that are effective at producing weight loss to assure the best results. PMID:22435353

  14. Diabetes and Dietary Supplements

    MedlinePlus

    ... R S T U V W X Y Z Diabetes and Dietary Supplements: In Depth Share: On This ... health product or practice. Are dietary supplements for diabetes safe? Some dietary supplements may have side effects, ...

  15. 77 FR 50702 - Ranbaxy Laboratories Limited; Withdrawal of Approval of 27 Abbreviated New Drug Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... supplements thereto, is hereby withdrawn, effective September 21, 2012. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section...

  16. Medication Treatment Efficacy and Chronic Orofacial Pain.

    PubMed

    Clark, Glenn T; Padilla, Mariela; Dionne, Raymond

    2016-08-01

    Chronic pain in the orofacial region has always been a vexing problem for dentists to diagnose and treat effectively. For trigeminal neuropathic pain, there are 3 medications (gabapentinoids, tricyclic antidepressants, and serotonin-norepinephrine reuptake inhibitors) to use plus topical anesthetics that have therapeutic efficacy. For chronic daily headaches (often migraine in origin), 3 prophylactic medications have reasonable therapeutic efficacy (β-blockers, tricyclic antidepressants, and antiepileptic drugs). The 3 Food and Drug Administration-approved drugs for fibromyalgia (pregabalin, duloxetine, and milnacipran) are not robust, with poor efficacy. For osteroarthritis, nonsteroidal anti-inflammatory drugs have therapeutic efficacy and when gastritis contraindicates them, corticosteriod injections are helpful. PMID:27475515

  17. More New Medication Approvals.

    PubMed

    Turkoski, Beatrice B

    2016-01-01

    In the past year, the Federal Drug Administration (FDA) approved many new drugs for treating a wide variety of patient health problems. In a previous article, examples of approvals for the early part of last year were addressed. In this article, selected new FDA approvals through January 2016 are discussed. Nurses who are knowledgeable and informed about these new drugs will be able to answer patients' questions, clarify misunderstandings, and reduce the potential for medication misadventures. PMID:27441881

  18. Nutritional supplements and ergogenic AIDS.

    PubMed

    Liddle, David G; Connor, Douglas J

    2013-06-01

    Performance enhancing drugs, ergogenic aids, and supplements come in many forms. The financial, personal, social, and health-related impact of these substances has wide and varied consequences. This article reviews common substances and practices used by athletes. It discusses the history, use, effects, and adverse effects of androgenic anabolic steroids, peptide hormones, growth factors, masking agents, diuretics, volume expanders, β-blockers, amphetamines, caffeine, other stimulants, and creatine. The evidence base behind the use, safety, and efficacy of these items as well as testing for these substances is discussed. PMID:23668655

  19. Dietary nitrate supplementation and exercise performance.

    PubMed

    Jones, Andrew M

    2014-05-01

    Dietary nitrate is growing in popularity as a sports nutrition supplement. This article reviews the evidence base for the potential of inorganic nitrate to enhance sports and exercise performance. Inorganic nitrate is present in numerous foodstuffs and is abundant in green leafy vegetables and beetroot. Following ingestion, nitrate is converted in the body to nitrite and stored and circulated in the blood. In conditions of low oxygen availability, nitrite can be converted into nitric oxide, which is known to play a number of important roles in vascular and metabolic control. Dietary nitrate supplementation increases plasma nitrite concentration and reduces resting blood pressure. Intriguingly, nitrate supplementation also reduces the oxygen cost of submaximal exercise and can, in some circumstances, enhance exercise tolerance and performance. The mechanisms that may be responsible for these effects are reviewed and practical guidelines for safe and efficacious dietary nitrate supplementation are provided. PMID:24791915

  20. Reading Intervention in Middle and High Schools: Implementation Fidelity, Teacher Efficacy, and Student Achievement

    ERIC Educational Resources Information Center

    Cantrell, Susan Chambers; Almasi, Janice F.; Carter, Janis C.; Rintamaa, Margaret

    2013-01-01

    This study investigated teachers' efficacy and implementation in the context of a supplemental intervention for struggling adolescent readers. It examined teachers' efficacy at the start of their intervention training and investigated relationships among teachers' efficacy, implementation, and students' reading progress. The efficacy and…

  1. Five Supplements and Multiple Psychotic Symptoms: A Case Report

    PubMed Central

    Wong, Michelle K.; Darvishzadeh, Ayeh; Maler, Neal A.; Bota, Robert G.

    2016-01-01

    Dietary supplements, including vitamins, minerals, herbs, amino acids, and enzymes, have become increasingly more common and are used by approximately half of the US population. About three-fourths of supplements are obtained with no prescription from a physician, which raises medical concerns regarding safety as these products do not require US Food and Drug Administration approval. Common reasons for taking dietary supplements include improved mood, improved mental function, depression relief, anxiety reduction, and treatment of simple and migraine headaches. The use of herbs for medicinal purposes has a long-standing history among many cultures. We present the case of a 43-year-old man, who was taking dietary supplements, with a 6-month history of psychotic symptoms that increasingly caused impairment in functioning and eventually led to involuntary hospitalization. The published data with regard to supplements causing psychosis, herb-to-herb interaction, and reliability of herbal supplement manufacturers are discussed. PMID:27247830

  2. Efficacy and Safety of Oral Lactoferrin Supplementation in Combination with rHuEPO-β for the Treatment of Anemia in Advanced Cancer Patients Undergoing Chemotherapy: Open-Label, Randomized Controlled Study

    PubMed Central

    Madeddu, Clelia; Gramignano, Giulia; Mulas, Carlo; Sanna, Eleonora; Mantovani, Giovanni

    2010-01-01

    Advanced-stage cancer patients often suffer from anemia that closely resembles the anemia of chronic inflammatory diseases characterized by specific changes in iron homeostasis and absorption. i.v. iron improves the efficacy of recombinant human erythropoietin (rHuEPO) in anemic cancer patients undergoing chemotherapy. We report the results of an open-label, randomized, prospective trial aimed at testing the efficacy and safety of treatment with oral lactoferrin versus i.v. iron, both combined with rHuEPO, for the treatment of anemia in a population of 148 advanced cancer patients undergoing chemotherapy. All patients received s.c. rHuEPO-β, 30,000 UI once weekly for 12 weeks, and were randomly assigned to ferric gluconate (125 mg i.v. weekly) or lactoferrin (200 mg/day). Both arms showed a significant hemoglobin increase. No difference in the mean hemoglobin increase or the hematopoietic response, time to hematopoietic response, or mean change in serum iron, C-reactive protein, or erythrocyte sedimentation rate were observed between arms. In contrast, ferritin decreased in the lactoferrin arm whereas it increased in the i.v. iron arm. In conclusion, these results show similar efficacy for oral lactoferrin and for i.v. iron, combined with rHuEPO, for the treatment of anemia in advanced cancer patients undergoing chemotherapy. PMID:20647390

  3. 77 FR 21453 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Revisions to New Source...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-10

    ...EPA is approving those revisions adopted by the State of Colorado on April 16, 2004 to Regulation No. 3 (Stationary Source Permitting and Air Pollutant Emission Notice Requirements) that incorporate EPA's December 31, 2002 NSR Reforms. Colorado submitted the request for approval of these rule revisions into the State Implementation Plan (SIP) on July 11, 2005 and supplemented its request on......

  4. 5 CFR 3601.107 - Prior approval for outside employment and business activities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside employment and business activities. 3601.107 Section 3601.107 Administrative Personnel DEPARTMENT OF DEFENSE SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF DEFENSE § 3601.107 Prior approval for outside employment and...

  5. 29 CFR 1952.354 - Final approval determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... Act and implementing regulations at 29 CFR part 1902. Accordingly, the Arizona plan was granted final... effective as operations under the Federal program; to submit plan supplements in accordance with 29 CFR...

  6. 29 CFR 1952.354 - Final approval determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... Act and implementing regulations at 29 CFR part 1902. Accordingly, the Arizona plan was granted final... effective as operations under the Federal program; to submit plan supplements in accordance with 29 CFR...

  7. 29 CFR 1952.354 - Final approval determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... Act and implementing regulations at 29 CFR part 1902. Accordingly, the Arizona plan was granted final... effective as operations under the Federal program; to submit plan supplements in accordance with 29 CFR...

  8. 5 CFR 3301.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... statute or Federal regulation, including 5 CFR part 2635. (c) Definition of employment. For purposes of.... 3301.103 Section 3301.103 Administrative Personnel DEPARTMENT OF ENERGY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF ENERGY § 3301.103 Prior approval for outside...

  9. 5 CFR 3301.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... statute or Federal regulation, including 5 CFR part 2635. (c) Definition of employment. For purposes of.... 3301.103 Section 3301.103 Administrative Personnel DEPARTMENT OF ENERGY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF ENERGY § 3301.103 Prior approval for outside...

  10. 5 CFR 3301.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... statute or Federal regulation, including 5 CFR part 2635. (c) Definition of employment. For purposes of.... 3301.103 Section 3301.103 Administrative Personnel DEPARTMENT OF ENERGY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF ENERGY § 3301.103 Prior approval for outside...

  11. 5 CFR 3301.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... statute or Federal regulation, including 5 CFR part 2635. (c) Definition of employment. For purposes of.... 3301.103 Section 3301.103 Administrative Personnel DEPARTMENT OF ENERGY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF ENERGY § 3301.103 Prior approval for outside...

  12. 5 CFR 3301.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... statute or Federal regulation, including 5 CFR part 2635. (c) Definition of employment. For purposes of.... 3301.103 Section 3301.103 Administrative Personnel DEPARTMENT OF ENERGY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF ENERGY § 3301.103 Prior approval for outside...

  13. 5 CFR 4301.101 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside employment. 4301.101 Section 4301.101 Administrative Personnel OVERSEAS PRIVATE INVESTMENT CORPORATION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OVERSEAS PRIVATE INVESTMENT CORPORATION § 4301.101...

  14. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Virginia plan... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to...

  15. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Virginia plan... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to...

  16. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Virginia plan... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to...

  17. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Virginia plan... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to...

  18. 14 CFR 121.162 - ETOPS Type Design Approval Basis.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false ETOPS Type Design Approval Basis. 121.162... REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Aircraft Requirements § 121.162 ETOPS Type Design... February 17, 2015 and except for a two-engine airplane that, when used in ETOPS, is only used for ETOPS...

  19. 29 CFR 1952.224 - Final approval determination.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Tennessee plan... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to allocate...

  20. 77 FR 11452 - Approval and Promulgation of Air Quality Implementation Plans; State of Georgia; Regional Haze...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ...EPA is proposing a limited approval of a revision to the Georgia state implementation plan (SIP) submitted by the State of Georgia through the Georgia Department of Natural Resources, Environmental Protection Division (GA EPD), on February 11, 2010, as supplemented on November 19, 2010, that addresses regional haze for the first implementation period. This SIP revision, as supplemented,......

  1. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order... continued distribution of the device would cause serious, adverse health consequences or death....

  2. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order... continued distribution of the device would cause serious, adverse health consequences or death....

  3. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order... continued distribution of the device would cause serious, adverse health consequences or death....

  4. 75 FR 6186 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 205...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-08

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 205, Publicizing Contract Actions AGENCY: Defense Acquisition Regulations System... approved information collection requirement. SUMMARY: In compliance with Section 3506(c)(2)(A) of...

  5. 75 FR 12518 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 237...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-16

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 237, Service Contracting AGENCY: Defense Acquisition Regulations System... approved information collection requirement. SUMMARY: In compliance with Section 3506(c)(2)(A) of...

  6. 78 FR 15935 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS); Bonds and Insurance AGENCY: Defense Acquisition Regulations System, Department... approved information collection requirement. SUMMARY: In compliance with Section 3506(c)(2)(A) of...

  7. 75 FR 20825 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; DoD Pilot...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; DoD Pilot Mentor-Protege Program AGENCY: Defense Acquisition Regulations System... approved information collection requirement. ] SUMMARY: In compliance with section 3506(c)(2)(A) of...

  8. 75 FR 20825 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 211...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 211, Describing Agency Needs AGENCY: Defense Acquisition Regulations System... approved information collection requirement. SUMMARY: In compliance with Section 3506(c)(2)(A) of...

  9. 78 FR 70025 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Subcontracting Policies and Procedures AGENCY: Defense Acquisition Regulations System... approved information collection requirement. SUMMARY: In compliance with section 3506(c)(2)(A) of...

  10. The Seal of Approval.

    ERIC Educational Resources Information Center

    Ziv, Micaela

    1997-01-01

    Israel's Software Evaluation Project sets national standards for hardware and software that is used in schools. All courseware must be approved for technical requirements and pedagogical content. After approval, the courseware is certified for use within Israel's school system for 2 years. Three times each year, schools, inspectorates, and…

  11. Evaluating the Efficacy of Three U.S. Department of Agriculture-Approved Antimicrobial Sprays for Reducing Shiga Toxin-Producing Escherichia coli Surrogate Populations on Bob Veal Carcasses.

    PubMed

    2016-06-01

    Effective antimicrobial intervention strategies to reduce Shiga toxin-producing Escherichia coli (STEC) risks associated with veal are needed. This study evaluated the efficacy of lactic acid (4.5%, pH 2.0), Citrilow (pH 1.2), and Beefxide (2.25%, pH 2.3) for reducing STEC surrogates on prerigor and chilled bob veal carcasses and monitored the effects of these interventions on chilled carcass color. Dehided bob veal carcasses were inoculated with a five-strain cocktail of rifampin-resistant, surrogate E. coli bacteria.E. coli surrogates were enumerated after inoculation, after water wash, after prechill carcass antimicrobial spray application, after chilling for 24 h, and after postchill carcass antimicrobial spray application; carcass color was measured throughout the process. A standard carcass water wash (∼50°C) reduced the STEC surrogate population by 0.9 log CFU/cm(2) (P ≤ 0.05). All three antimicrobial sprays applied to prerigor carcasses delivered an additional ∼0.5-log reduction (P ≤ 0.05) of the surrogates. Chilling of carcasses for 24 h reduced (P ≤ 0.05) the surrogate population by an additional ∼0.4 log cycles. The postchill application of the antimicrobial sprays provided no further reductions. Carcass L*, a*, and b* color values were not different (P > 0.05) among carcass treatments. Generally, the types and concentrations of the antimicrobial sprays evaluated herein did not negatively impact visual or instrumental color of chilled veal carcasses. This study demonstrates that warm water washing, followed by a prechill spray treatment with a low-pH chemical intervention, can effectively reduce STEC risks associated with veal carcasses; this provides processors a validated control point in slaughter operations. PMID:27296599

  12. Efficacy of High-Dose Supplementation With Oral Vitamin D3 on Depressive Symptoms in Dialysis Patients With Vitamin D3 Insufficiency: A Prospective, Randomized, Double-Blind Study.

    PubMed

    Wang, Ying; Liu, Ying; Lian, Yueying; Li, Ning; Liu, Hong; Li, Guanzeng

    2016-06-01

    Psychological problems are common among end-stage renal disease patients undergoing dialysis. We aim to evaluate whether high-dose vitamin D3 (VD3) supplementation has beneficial effects on depressive symptoms in dialysis patients. This prospective, randomized, and double-blind trial includes 746 dialysis patients with depression treated in 3 hospitals in Southeast China. Depression was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders criteria. Patients were randomly assigned to 52-week treatment of oral 50,000 IU/wk VD3 (cholecalciferol) (test group) or a placebo (control group). The presence of depressive symptoms was evaluated using the Chinese version of Beck Depression Inventory (BDI) II both before and after treatment. Sociodemographic data, clinical data, nutritional indexes, inflammatory biomarkers, and plasma VD3 concentrations were also determined. Finally, 726 patients completed the experiments, including 362 tested patients and 364 controls. After 52 weeks, the depressive symptoms were not significantly improved in the test group (mean BDI II scores changed from -1.1 ± 0.3 to -3.1 ± 0.6) versus the control group. Multivariable logistic regression showed BDI scores were not significantly improved in the test group versus the control group with adjustment for age, sex, comorbidity index, dialysis modality, or (OH)D levels (multivariable-adjusted mean change or MAMC [95% confidence interval (CI)], -2.3 [-2.48 to -1.83]) in the whole dialysis population. After stratification by depression types, the findings do support a significant relationship between the VD3 supplementation and the improvement in BDI II scores in dialysis patients with vascular depression (MAMC [95% CI], -4.4 [-5.08 to -2.76]), but the effect was not significant for major depressive disorders (MAMC [95% CI], -0.9 [-1.52 to -0.63]). The high-dose VD3 supplementation did not significantly reduce the depressive symptoms in our total dialysis population, but

  13. Drugs Approved for Thyroid Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) ...

  14. Drugs Approved for Prostate Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Prostate Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Prostate Cancer Abiraterone Acetate Bicalutamide Cabazitaxel Casodex (Bicalutamide) Degarelix Docetaxel ...

  15. Drugs Approved for Brain Tumors

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Brain Tumors This page lists cancer drugs approved by ... that are not listed here. Drugs Approved for Brain Tumors Afinitor (Everolimus) Afinitor Disperz (Everolimus) Avastin (Bevacizumab) ...

  16. Drugs Approved for Breast Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Breast Cancer This page lists cancer drugs approved by the ... are not listed here. Drugs Approved to Prevent Breast Cancer Evista (Raloxifene Hydrochloride) Keoxifene (Raloxifene Hydrochloride) Nolvadex (Tamoxifen ...

  17. Drugs Approved for Bone Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Bone Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Bone Cancer Abitrexate (Methotrexate) Cosmegen (Dactinomycin) Dactinomycin Denosumab Doxorubicin Hydrochloride ...

  18. Drugs Approved for Myeloproliferative Disorders

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Myeloproliferative Neoplasms This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Myeloproliferative Neoplasms Adriamycin PFS (Doxorubicin Hydrochloride) Adriamycin RDF (Doxorubicin Hydrochloride) ...

  19. Sofosbuvir: first global approval.

    PubMed

    Keating, Gillian M; Vaidya, Asha

    2014-02-01

    Sofosbuvir (Solvadi™), a nucleotide analogue hepatitis C virus NS5B polymerase inhibitor, is under development with Gilead Sciences for the once-daily, oral treatment of chronic hepatitis C. Oral sofosbuvir has been approved in the US for the treatment of chronic hepatitis C as a component of a combination antiviral regimen. In addition, the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of sofosbuvir for the treatment of chronic hepatitis C. This article summarizes the milestones in the development of sofosbuvir leading to this first approval for chronic hepatitis C. PMID:24442794

  20. Multivitamin/Mineral Supplements

    MedlinePlus

    ... Nutrient recommendations: Dietary Reference Intakes (DRI) Online DRI tool Daily Value (DV) tables For more advice on buying dietary supplements: Office of Dietary Supplements Frequently Asked Questions: Which brand(s) ...

  1. Children and Dietary Supplements

    MedlinePlus

    ... NCCIH Clinical Digest for health professionals Children and Dietary Supplements Share: September 2012 © Matthew Lester Research has shown that many children use herbs and other dietary supplements. However, there are little data available on their ...

  2. Drugs Approved for Melanoma

    MedlinePlus

    ... are not listed here. Drugs Approved for Melanoma Aldesleukin Cobimetinib Cotellic (Cobimetinib) Dabrafenib Dacarbazine DTIC-Dome (Dacarbazine) IL-2 (Aldesleukin) Imlygic (Talimogene Laherparepvec) Interleukin-2 (Aldesleukin) Intron A ( ...

  3. Drugs Approved for Leukemia

    Cancer.gov

    This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  4. Drugs Approved for Retinoblastoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  5. Drugs Approved for Neuroblastoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  6. 5 CFR 5502.103 - Content of annual supplemental reports.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... part 5501 of this chapter that were approved pursuant to 5 CFR 5501.106(d) or undertaken within the.... 5502.103 Section 5502.103 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES §...

  7. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... sufficiency of animal data, the agency may take into account other data, including human data, available to... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610...

  8. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... sufficiency of animal data, the agency may take into account other data, including human data, available to... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610...

  9. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... sufficiency of animal data, the agency may take into account other data, including human data, available to... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610...

  10. Development of Safe and Effective Botanical Dietary Supplements

    PubMed Central

    2015-01-01

    Regulated differently than drugs or foods, the market for botanical dietary supplements continues to grow worldwide. The recently implemented U.S. FDA regulation that all botanical dietary supplements must be produced using good manufacturing practice is an important step toward enhancing the safety of these products, but additional safeguards could be implemented, and unlike drugs, there are currently no efficacy requirements. To ensure a safe and effective product, botanical dietary supplements should be developed in a manner analogous to pharmaceuticals that involves identification of mechanisms of action and active constituents, chemical standardization based on the active compounds, biological standardization based on pharmacological activity, preclinical evaluation of toxicity and potential for drug–botanical interactions, metabolism of active compounds, and finally, clinical studies of safety and efficacy. Completing these steps will enable the translation of botanicals from the field to safe human use as dietary supplements. PMID:26125082

  11. Punishments: What Predicts Adult Approval.

    ERIC Educational Resources Information Center

    Buntain-Ricklefs, Joanne J.; And Others

    1994-01-01

    A survey of 449 parents found that 24% experienced uncommon punishments (such as burning) during their childhoods and 6% approved; 45% experienced and 17% approved of common punishments (shaking); and 94% experienced and 88% approved of very common punishments (spanking). Approval of each punishment was related to experience. Race, income, and…

  12. 34 CFR 200.88 - Exclusion of supplemental State and local funds from supplement, not supplant and comparability...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... under part C of Title I may exclude supplemental State and local funds expended in any school attendance area or school for carrying out special programs that meet the intent and purposes of part C of Title I... met. (Approved by the Office of Management and Budget under control number 1810-0662) (Authority 20...

  13. Target selection for FDA-approved medicines.

    PubMed

    Kinch, Michael S; Hoyer, Denton; Patridge, Eric; Plummer, Mark

    2015-07-01

    The biopharmaceutical industry translates fundamental understanding of disease into new medicines. As part of a comprehensive analysis of FDA-approved new molecular entities (NMEs), we assessed the mechanistic basis of drug efficacy, with emphasis on target selection. Three target families capture almost half of all NMEs and the leading ten families capture more than three-quarters of NME approvals. Target families were related to their clinical application and identify dynamic trends in targeting over time. These data suggest increasing attention toward novel target families, which presumably reflects increased understanding of disease etiology. We also suggest the need to balance the ongoing emphasis on target-based drug discovery with phenotypic approaches to drug discovery. PMID:25462532

  14. OLDER ADULTS WHO USE VITAMIN/MINERAL SUPPLEMENTS DIFFER FROM NONUSERS IN NUTRIENT INTAKE ADEQUACY AND DIETARY ATTITUDES

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The purpose of this study was to measure nutrient intake adequacy of vitamin/mineral supplement users and nonusers 51 years and older, determine the efficacy of current supplement practices, and identify predictors of supplement use. Two 24-hour recalls, and demographic and attitude information fro...

  15. Fall prevention with supplemental and alpha-hydroxylated vitamin D: a meta-analysis of randomized controlled trials

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Results from fall prevention trials with supplemental vitamin D have been mixed and a possible differential benefit of supplemental versus alpha-hydroxylated vitamin D (activeD) has not been established. We performed a meta-analysis on the efficacy of supplemental vitamin D and activeD with or witho...

  16. Ibrutinib: first global approval.

    PubMed

    Cameron, Fiona; Sanford, Mark

    2014-02-01

    Ibrutinib (Imbruvica™) is a small molecule, first-in-class, once-daily, orally available, Bruton's tyrosine kinase inhibitor that is under development for the treatment of B cell malignancies, including chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL), as well as multiple myeloma (MM), follicular lymphoma (FL) and Waldenstrom's macroglobulinemia (WM). It has been developed by Pharmacyclics, Inc. and Janssen Biotech, Inc. Ibrutinib acts by blocking B-cell antigen receptor signalling, thereby reducing malignant proliferation of B cells and inducing cell death. Based chiefly on findings from a phase Ib/II study, ibrutinib has been approved in the USA for the treatment of MCL in previously treated patients and is one of the first approvals through the US FDA's Breakthrough Therapy Designation Pathway. An application has been filed in the EU seeking regulatory approval in this indication. In both the USA and EU, further applications have been filed with regulatory bodies seeking approval for the use of ibrutinib in patients with previously treated CLL/small lymphocytic lymphoma (SLL). Phase III trials are underway worldwide to evaluate ibrutinib in the treatment of patients with CLL/SLL, DLBCL and MCL, and the agent is in phase II development for use in WM, FL and MM. This article summarizes the milestones in the development of ibrutinib leading to its first approval in MCL. PMID:24464309

  17. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  18. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  19. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  20. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  1. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  2. MSHA approval process

    SciTech Connect

    Chirdon, D.C.

    1999-07-01

    The hazardous nature of the underground mining environment necessitates the use of equipment and mining products designed to ensure safe usage in this hostile environment. Title 30, code of federal regulations (30 CFR) includes requirements that all equipment and products intended for use in potentially gassy areas of underground mines be approved by the mine safety and health administration (MSHA). Design and performance requirements for many of the products intended for use in the underground environment are also part of 30 CFR. This paper describes the processes available to potential applicants for obtaining MSHA approval. Emphasis is placed on ventilation-related products. A program available to operators for modifying approved equipment is described. A proposed regulation that would broaden the scope of design standards accepted by MSHA is discussed.

  3. Ramucirumab: first global approval.

    PubMed

    Poole, Raewyn M; Vaidya, Asha

    2014-06-01

    Ramucirumab (Cyramza™ [US]), a fully human immunoglobulin G1 (IgG1) monoclonal antibody that inhibits vascular endothelial growth factor receptor-2 (VEGFR-2), has been developed by Eli Lilly (formerly ImClone Systems) for the treatment of cancer. Ramucirumab has received its first global approval in the US for use as monotherapy in the treatment of advanced or metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in patients who experience disease progression on or after fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is the first treatment to be approved by the US FDA for this setting. This article summarizes the milestones in the development of ramucirumab leading to this first approval for the treatment of gastric cancer and gastro-oesophageal junction adenocarcinoma. PMID:24916147

  4. Marketing approval of mogamulizumab

    PubMed Central

    Beck, Alain; Reichert, Janice M.

    2012-01-01

    Therapeutic properties of antibodies strongly depend on the composition of their glycans. Most of the currently approved antibodies are produced in mammalian cell lines, which yield mixtures of different glycoforms that are close to those of humans, but not fully identical. Glyco-engineering is being developed as a method to control the composition of carbohydrates and to enhance the pharmacological properties of mAbs. The recent approval in Japan of mogamulizumab (POTELIGEO®), the first glyco-engineered antibody to reach the market, is a landmark in the field of therapeutic antibodies. Mogamulizumab is a humanized mAb derived from Kyowa Hakko Kirin’s POTELLIGENT® technology, which produces antibodies with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity. The approval was granted April 30, 2012 by the Japanese Ministry of Health, Labour and Welfare for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma. PMID:22699226

  5. Pimavanserin: First Global Approval.

    PubMed

    Markham, Anthony

    2016-07-01

    Pimavanserin (Nuplazid™) is a selective and potent serotonin 2A (5-HT2A) receptor inverse agonist and antagonist developed by ACADIA Pharmaceuticals that has been approved in the US as a treatment for patients with hallucinations and delusions associated with Parkinson's disease psychosis. Up to 60 % of patients with Parkinson's disease may develop Parkinson's disease psychosis, which is associated with increased morbidity and mortality and has few treatment options. This article summarizes the milestones in the development of pimavanserin leading to this first approval for the treatment of hallucinations and delusions in patients with Parkinson's disease psychosis. PMID:27262680

  6. Migalastat: First Global Approval.

    PubMed

    Markham, Anthony

    2016-07-01

    Migalastat (Galafold™)-a small molecule drug developed by Amicus Therapeutics that restores the activity of specific mutant forms of α-galactosidase-has been approved for the treatment of Fabry disease in the EU in patients with amenable mutations. Fabry disease is a rare disorder that results in a deficiency or absence of α-galactosidase, leading to accumulation of globotriaosylceramide in the lysosomes of various cells. This article summarizes the milestones in the development of migalastat leading to this first approval in the EU for the long-term treatment of adults and adolescents aged ≥16 years with a confirmed diagnosis of Fabry disease. PMID:27351440

  7. Brodalumab: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-09-01

    Brodalumab (Lumicef(®)) is a human monoclonal immunoglobulin G antibody that is being developed by Kyowa Hakko Kirin in Japan, where it has been approved for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. Brodalumab binds with high affinity to interleukin (IL)-17 receptor A, thereby inhibiting several pro-inflammatory cytokines from the IL-17 family. Regulatory applications for brodalumab in plaque psoriasis are also under review in the USA, EU and Canada. This article summarizes the milestones in the development of brodalumab leading to this first approval for the treatment of psoriasis. PMID:27577550

  8. Supplementation in the Columbia Basin : Summary Report Series : Final Report.

    SciTech Connect

    United States. Bonneville Power Administration.

    1992-12-01

    of Supplementation Project (RASP) was initiated as a result of a request by NPPC to address long-standing concerns about the need to coordinate supplementation research, monitoring and evaluation. Such coordination was also recommended by the Supplementation Technical Work Group. In August 1990, the NPPC gave conditional approval to proceed with the final design of the Yakima Production Project. The Council called on the Bonneville Power Administration (BPA) to fund immediately a supplementation assessment to reevaluate, prioritize and coordinate all existing and planned supplementation monitoring and evaluation activities in the basin. Providing for the participation of the fishery agencies and tribes and others having expertise in this area. RASP addresses four principal objectives: (1) provide an overview of ongoing and planned supplementation activities and identify critical uncertainties associated with supplementation, (2) construct a conceptual framework and model which estimates the potential benefits and risks of supplementation and prioritizes uncertainties, (3) provide guidelines for the development of supplementation projects, (4) develop a plan for regional coordination of research and monitoring. These objectives, once attained, will provide the technical tools fishery managers need to carry out the Council's direction to protect and enhance salmon and steelhead. RASP has further divided the four broad objectives into 12 technical topics: (1) definition of supplementation; (2) description of the diversity of supplementation projects; (3) objectives and performance standards; (4) identification of uncertainties; (5) supplementation theory; (6) development of a conceptual model of supplemented populations; (7) development of spreadsheet model of risks and benefits of supplementation; (8) classification of stocks, streams, and supplementation strategies; (9) regional design of supplementation evaluation and monitoring; (10) guidelines for planning

  9. [Efficacy studies].

    PubMed

    Pedro-Botet, Juan; Flores-Le Roux, Juana A

    2014-07-01

    Pravafenix(®) is a fixed-dose combination of 40mg of pravastatin and 160 mg of fenofibrate. The rationale behind the use of Pravafenix(®) is based on the increased residual cardiovascular risk observed in high risk patients with hypertriglyceridemia and/or low HDL cholesterol levels despite treatment with statins in monotherapy. In this article, we review the available evidence on the clinical efficacy of Pravafenix(®), which shows complementary benefits in the overall lipid profile of high risk patients with mixed dyslipidemia not controlled with 40-mg pravastatin or 20-mg simvastatin. PMID:25043542

  10. Fatty Acid and Phytosterol Content of Commercial Saw Palmetto Supplements

    PubMed Central

    Penugonda, Kavitha; Lindshield, Brian L.

    2013-01-01

    Saw palmetto supplements are one of the most commonly consumed supplements by men with prostate cancer and/or benign prostatic hyperplasia (BPH). Some studies have found significant improvements in BPH and lower urinary tract symptoms (LUTS) with saw palmetto supplementation, whereas others found no benefits. The variation in the efficacy in these trials may be a result of differences in the putative active components, fatty acids and phytosterols, of the saw palmetto supplements. To this end, we quantified the major fatty acids (laurate, myristate, palmitate, stearate, oleate, linoleate) and phytosterols (campesterol, stigmasterol, β-sitosterol) in 20 commercially available saw palmetto supplements using GC-FID and GC-MS, respectively. Samples were classified into liquids, powders, dried berries, and tinctures. Liquid saw palmetto supplements contained significantly higher (p < 0.05) concentrations of total fatty acids (908.5 mg/g), individual fatty acids, total phytosterols (2.04 mg/g), and individual phytosterols, than the other supplement categories. Powders contained significantly higher (p < 0.05) concentrations of total fatty acids than tinctures, which contain negligible amounts of fatty acids (46.3 mg/g) and phytosterols (0.10 mg/g). Our findings suggest that liquid saw palmetto supplements may be the best choice for individuals who want to take a saw palmetto supplement with the highest concentrations of both fatty acids and phytosterols. PMID:24067389

  11. Integrating dietary supplements into cancer care.

    PubMed

    Frenkel, Moshe; Abrams, Donald I; Ladas, Elena J; Deng, Gary; Hardy, Mary; Capodice, Jillian L; Winegardner, Mary F; Gubili, J K; Yeung, K Simon; Kussmann, Heidi; Block, Keith I

    2013-09-01

    Many studies confirm that a majority of patients undergoing cancer therapy use self-selected forms of complementary therapies, mainly dietary supplements. Unfortunately, patients often do not report their use of supplements to their providers. The failure of physicians to communicate effectively with patients on this use may result in a loss of trust within the therapeutic relationship and in the selection by patients of harmful, useless, or ineffective and costly nonconventional therapies when effective integrative interventions may exist. Poor communication may also lead to diminishment of patient autonomy and self-efficacy and thereby interfere with the healing response. To be open to the patient's perspective, and sensitive to his or her need for autonomy and empowerment, physicians may need a shift in their own perspectives. Perhaps the optimal approach is to discuss both the facts and the uncertainty with the patient, in order to reach a mutually informed decision. Today's informed patients truly value physicians who appreciate them as equal participants in making their own health care choices. To reach a mutually informed decision about the use of these supplements, the Clinical Practice Committee of The Society of Integrative Oncology undertook the challenge of providing basic information to physicians who wish to discuss these issues with their patients. A list of leading supplements that have the best suggestions of benefit was constructed by leading researchers and clinicians who have experience in using these supplements. This list includes curcumin, glutamine, vitamin D, Maitake mushrooms, fish oil, green tea, milk thistle, Astragalus, melatonin, and probiotics. The list includes basic information on each supplement, such as evidence on effectiveness and clinical trials, adverse effects, and interactions with medications. The information was constructed to provide an up-to-date base of knowledge, so that physicians and other health care providers would

  12. Should supplemental antioxidant administration be avoided during chemotherapy and radiation therapy?

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Despite nearly two decades of research investigating the use of dietary antioxidant supplementation during conventional chemotherapy and radiation therapy, controversy remains about the efficacy and safety of this complementary treatment. Several studies of concurrent antioxidant administration with...

  13. Calcium supplements: benefits and risks.

    PubMed

    Reid, I R; Bristow, S M; Bolland, M J

    2015-10-01

    Calcium is an essential element in the diet, but there is continuing controversy regarding its optimal intake, and its role in the pathogenesis of osteoporosis. Most studies show little evidence of a relationship between calcium intake and bone density, or the rate of bone loss. Re-analysis of data from the placebo group from the Auckland Calcium Study demonstrates no relationship between dietary calcium intake and rate of bone loss over 5 years in healthy older women with intakes varying from <400 to >1500 mg day(-1) . Thus, supplements are not needed within this range of intakes to compensate for a demonstrable dietary deficiency, but might be acting as weak anti-resorptive agents via effects on parathyroid hormone and calcitonin. Consistent with this, supplements do acutely reduce bone resorption and produce small short-term effects on bone density, without evidence of a cumulative density benefit. As a result, anti-fracture efficacy remains unproven, with no evidence to support hip fracture prevention (other than in a cohort with severe vitamin D deficiency) and total fracture numbers are reduced by 0-10%, depending on which meta-analysis is considered. Five recent large studies have failed to demonstrate fracture prevention in their primary analyses. This must be balanced against an increase in gastrointestinal side effects (including a doubling of hospital admissions for these problems), a 17% increase in renal calculi and a 20-40% increase in risk of myocardial infarction. Each of these adverse events alone neutralizes any possible benefit in fracture prevention. Thus, calcium supplements appear to have a negative risk-benefit effect, and so should not be used routinely in the prevention or treatment of osteoporosis. PMID:26174589

  14. GI Course Approvals.

    ERIC Educational Resources Information Center

    Orlans, Harold; And Others

    The process by which institutions and courses are approved for veterans educational benefits is examined in this study mandated by Public Law 95-202. The legislative background of the investigation is described as well as the history of the Servicemen's Readjustment Act of 1944, the Korean Bill of 1952, and P.L. 94-502 of 1976. A summary guide to…

  15. FDA Approval for Imiquimod

    Cancer.gov

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  16. Venetoclax: First Global Approval.

    PubMed

    Deeks, Emma D

    2016-06-01

    Venetoclax (Venclexta™) is an oral selective inhibitor of the prosurvival protein BCL-2 and therefore restores the apoptotic ability of malignant cells. The drug arose from research by Abbott Laboratories (now AbbVie) during a collaboration with Genentech and is being co-developed by AbbVie and Genentech/Roche primarily for the treatment of haematological malignancies. Venetoclax is approved in the USA for use as monotherapy in patients with chronic lymphocytic leukaemia (CLL) with the 17p deletion (as detected by an approved FDA test) who have received at least one prior therapy, and is awaiting approval for similar indications in the EU and Canada. Venetoclax is also in phase I-III development as combination therapy for CLL, phase I/II development as monotherapy and/or combination therapy for non-Hodgkin lymphomas (including diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma) and acute myeloid leukaemia, and phase I development for multiple myeloma, systemic lupus erythematosus and breast cancer. This article summarizes the milestones in the development of venetoclax leading to this first approval for CLL. PMID:27260335

  17. VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health

    PubMed Central

    Allen, Katrina J; Panjari, Mary; Koplin, Jennifer J; Ponsonby, Anne-Louise; Vuillermin, Peter; Gurrin, Lyle C; Greaves, Ronda; Carvalho, Natalie; Dalziel, Kim; Tang, Mimi L K; Lee, Katherine J; Wake, Melissa; Curtis, Nigel; Dharmage, Shyamali C

    2015-01-01

    Introduction Postnatal vitamin D supplementation may be associated with a reduction in IgE-mediated food allergy, lower respiratory tract infections and improved bone health. Countries in the Northern hemisphere recommend universal infant vitamin D supplementation to optimise early vitamin D levels, despite the absence of large trials proving safety or efficacy for any disease outcome. With the aim of determining the clinical and cost-effectiveness of daily vitamin D supplementation in breastfed infants from age 6–8 weeks to 12 months of age, we have started a double-blind, randomised, placebo-controlled trial of daily 400 IU vitamin D supplementation during the first year of life, VITALITY. Methods nd analysis Infants (n=3012) who are fully breastfed and not receiving vitamin D supplementation will be recruited at the time of their first immunisation, from council-led immunisation clinics throughout metropolitan Melbourne, Australia. The primary outcome is challenge-proven food allergy at 12 months of age. Secondary outcomes are food sensitisation (positive skin prick test), number of lower respiratory infections (through hospital linkage), moderately-severe and persistent eczema (by history and examination) and vitamin D deficiency (serum vitamin D <50 nmol/L) at age 12 months. The trial is underway and the first 130 participants have been recruited. Ethics and dissemination The VITALITY study is approved by the Royal Children's Hospital (RCH) Human Research Ethics Committee (#34168). Outcomes will be disseminated through publication and will be presented at scientific conferences. Trial registration numbers ANZCTR12614000334606 and NCT02112734; pre-results. PMID:26674499

  18. Family Living Supplement.

    ERIC Educational Resources Information Center

    Truitt, Debbie

    This family living supplement contains 125 supplemental ideas and strategies designed to help vocational home economics teachers increase student motivation and enrich the teaching process. Ideas and strategies are organized into seven sections. These are career planning, securing a job, and career success; managing financial resources, buying…

  19. Drugs Approved for Lung Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Lung Cancer This page lists cancer ... in lung cancer that are not listed here. Drugs Approved for Non-Small Cell Lung Cancer Abitrexate ( ...

  20. Drugs Approved for Bladder Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Bladder Cancer This page lists cancer ... in bladder cancer that are not listed here. Drugs Approved for Bladder Cancer Atezolizumab Cisplatin Doxorubicin Hydrochloride ...

  1. Drugs Approved for Hodgkin Lymphoma

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Hodgkin Lymphoma This page lists cancer ... in Hodgkin lymphoma that are not listed here. Drugs Approved for Hodgkin Lymphoma Adcetris (Brentuximab Vedotin) Ambochlorin ( ...

  2. Drugs Approved for Pancreatic Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Pancreatic Cancer This page lists cancer ... in pancreatic cancer that are not listed here. Drugs Approved for Pancreatic Cancer Abraxane (Paclitaxel Albumin-stabilized ...

  3. Drugs Approved for Testicular Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Testicular Cancer This page lists cancer ... in testicular cancer that are not listed here. Drugs Approved for Testicular Cancer Blenoxane (Bleomycin) Bleomycin Cisplatin ...

  4. Drugs Approved for Malignant Mesothelioma

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Malignant Mesothelioma This page lists cancer ... in malignant mesothelioma that are not listed here. Drugs Approved for Malignant Mesothelioma Alimta (Pemetrexed Disodium) Pemetrexed ...

  5. Drugs Approved for Vulvar Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Vulvar Cancer This page lists cancer ... in vulvar cancer that are not listed here. Drugs Approved to Prevent Vulvar Cancer Gardasil (Recombinant HPV ...

  6. Drugs Approved for Cervical Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Cervical Cancer This page lists cancer ... in cervical cancer that are not listed here. Drugs Approved to Prevent Cervical Cancer Cervarix (Recombinant HPV ...

  7. Drugs Approved for Skin Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Skin Cancer This page lists cancer ... in skin cancer that are not listed here. Drugs Approved for Basal Cell Carcinoma Aldara (Imiquimod) Efudex ( ...

  8. Is It Really FDA Approved?

    MedlinePlus

    ... and implantable infusion pumps, require FDA approval before marketing. To receive FDA approval for these devices, the ... and many types of catheters) are cleared for marketing based on an FDA determination that they are ...

  9. Use of biomarkers for assessing radiation injury and efficacy of countermeasures

    PubMed Central

    Singh, Vijay K; Newman, Victoria L; Romaine, Patricia LP; Hauer-Jensen, Martin; Pollard, Harvey B

    2016-01-01

    Several candidate drugs for acute radiation syndrome (ARS) have been identified that have low toxicity and significant radioprotective and radiomitigative efficacy. Inasmuch as exposing healthy human volunteers to injurious levels of radiation is unethical, development and approval of new radiation countermeasures for ARS are therefore presently based on animal studies and Phase I safety study in healthy volunteers. The Animal Efficacy Rule, which underlies the Food and Drug Administration approval pathway, requires a sound understanding of the mechanisms of injury, drug efficacy, and efficacy biomarkers. In this context, it is important to identify biomarkers for radiation injury and drug efficacy that can extrapolate animal efficacy results, and can be used to convert drug doses deduced from animal studies to those that can be efficacious when used in humans. Here, we summarize the progress of studies to identify candidate biomarkers for the extent of radiation injury and for evaluation of countermeasure efficacy. PMID:26568096

  10. Use of biomarkers for assessing radiation injury and efficacy of countermeasures.

    PubMed

    Singh, Vijay K; Newman, Victoria L; Romaine, Patricia Lp; Hauer-Jensen, Martin; Pollard, Harvey B

    2016-01-01

    Several candidate drugs for acute radiation syndrome (ARS) have been identified that have low toxicity and significant radioprotective and radiomitigative efficacy. Inasmuch as exposing healthy human volunteers to injurious levels of radiation is unethical, development and approval of new radiation countermeasures for ARS are therefore presently based on animal studies and Phase I safety study in healthy volunteers. The Animal Efficacy Rule, which underlies the Food and Drug Administration approval pathway, requires a sound understanding of the mechanisms of injury, drug efficacy, and efficacy biomarkers. In this context, it is important to identify biomarkers for radiation injury and drug efficacy that can extrapolate animal efficacy results, and can be used to convert drug doses deduced from animal studies to those that can be efficacious when used in humans. Here, we summarize the progress of studies to identify candidate biomarkers for the extent of radiation injury and for evaluation of countermeasure efficacy. PMID:26568096

  11. Supplemental instruction in chemistry

    NASA Astrophysics Data System (ADS)

    Lundeberg, Mary A.

    This study was designed to measure some effects of supplemental instruction in chemistry. Supplemental instruction is a peer-led cooperative learning program that encourages students to develop conceptual understanding by articulating both understandings and misconceptions in a think-aloud fashion. Supplemental instruction was offered three hours weekly outside of class and lab time for students in four classes of General Organic and Biological Chemistry. Over a two-year period 108 students volunteered to participate in this program; 45 students did not participate. As measured by final grades in chemistry and responses to a questionnaire, supplemental instruction was effective in increasing students' achievement in chemistry. Further research is needed to determine the in-depth effects of supplemental instruction on students' learning, problem solving, and self-esteem.

  12. Comparison of supplements to enhance recovery of thermally-injured Salmonella from liquid egg white

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The recovery of Salmonella from liquid egg white (LEW) is complicated by thermal and innate LEW antimicrobial-induced injury. Numerous supplements have been reported to promote the recovery of injured bacteria. The purpose of this study was to determine the efficacy of twelve media supplements to ...

  13. Comparison of supplements to enhance recovery of heat-injured Salmonella from egg albumen

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The recovery of Salmonella from liquid egg white (LEW) is complicated by thermal and innate LEW antimicrobial-induced injury. Numerous supplements have been reported to promote the recovery of injured bacteria. The purpose of this study was to determine the efficacy of twelve media supplements to af...

  14. Dietary supplements in the Department of Defense: possible solutions to optimizing force readiness.

    PubMed

    Gonsalves, Stephen; Stavinoha, Trisha; Hite, Linda; Costa, Janelle; Dilly, George; Deuster, Patricia A

    2012-12-01

    Dietary supplement use is common among military service members; approximately 17 to 20% report using high-risk weight-loss, performance-enhancing, and bodybuilding supplements. To date, no overarching policy or program has been approved or implemented to inform service members or educate health care providers on the potential adverse consequences of using multiple combinations of supplements or the pros and cons of supplements per se. A review of regulations, concerns, and possible solutions is provided. Importantly, the role of third-party certification and education is emphasized. PMID:23397690

  15. Why Take a Prenatal Supplement?

    MedlinePlus

    ... Newsroom Dietary Guidelines Communicator’s Guide Why take a prenatal supplement? You are here Home / Audience / Adults / Moms/ Moms-to-Be / Dietary Supplements Why take a prenatal supplement? Print Share During pregnancy, your needs increase ...

  16. Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated?

    PubMed

    Wallace, Taylor C

    2015-08-01

    The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines the FDA's statutory authority to regulate dietary supplement products in the United States. The dietary supplement industry has rapidly expanded since 1994, presenting an obvious need for "DSHEA 2.0." Current regulations surrounding dietary supplements have been increasingly and reasonably scrutinized, given their widespread use by over one-half of the US population as well as highly publicized safety concerns over the past 20 y. As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting. PMID:26063064

  17. Dietary Supplements are Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer.

    PubMed

    Sax, Joanna K

    2015-01-01

    Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as 'natural.' This leads many consumers to fail to question the supplements' safety, and some consumers even equate 'natural' with safe. But, 'natural' does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco--a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) requires safety and efficacy testing prior to market entry for drugs. In contrast, the FDA only has limited ability to regulate the entry of new dietary supplements into the marketplace because supplements are treated as food. Two main arguments support the current regulatory structure of dietary supplements: (1) cost and (2) access. But lower cost and increased access to dietary supplements do not necessary have any relationship to safety and efficacy. Manufacturers' marketing techniques tout the health benefits of their supplements. Meanwhile, consumers are ingesting supplements without scientific studies indicating whether or not they are harmful. The FDA Food Safety and Modernization Act, signed into law on January 4, 2011, did not address the safety concerns regarding dietary supplements. This article discusses the regulatory deficiencies concerning dietary supplements and proposes novel solutions to address this specific sector of the food supply. This article advocates for the use of scientific data to support a multi-tiered classification system to ensure that dietary supplements on the market are safe. PMID:26591824

  18. MUD and Self Efficacy.

    ERIC Educational Resources Information Center

    Lee, Kwan Min

    2000-01-01

    Proposes a theoretical framework for analyzing the effect of MUD (Multi-User Dungeons) playing on users' self-efficacy by applying Bandura's social learning theory, and introduces three types of self-efficacy: computer self-efficacy; social self-efficacy; and generalized self-efficacy. Considers successful performance, vicarious experience,…

  19. 21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... control personnel review and approve the documentation to determine whether the received product meets the specifications that you established under § 111.70(f); and (3) Quality control personnel approve the...

  20. Cariprazine: First Global Approval.

    PubMed

    McCormack, Paul L

    2015-11-01

    Cariprazine (Vraylar) is an oral atypical antipsychotic originated by Gedeon Richter. It is a potent dopamine D3 and D2 receptor partial agonist, which preferentially binds to the D3 receptor. Cariprazine also has partial agonist activity at serotonin 5-HT1A receptors. In September 2015, cariprazine received its first global approval in the USA for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder. It is also in development in a variety of countries for the treatment of schizophrenia with predominant negative symptoms (phase III), as adjunctive therapy for major depressive disorder (phase II/III) and for the treatment of bipolar depression (phase II). This article summarizes the milestones in the development of cariprazine leading to this first approval for schizophrenia and manic or mixed episodes associated with bipolar I disorder. PMID:26510944

  1. Cobimetinib: First Global Approval.

    PubMed

    Garnock-Jones, Karly P

    2015-10-01

    Genentech (a subsidiary of Roche) and Exelixis are developing cobimetinib, an orally available small molecule, for the treatment of various cancers, including malignant melanoma and breast cancer. Cobimetinib inhibits the MEK (mitogen-activated protein kinase) component of the MAPK/ERK signalling pathway, which is frequently over-activated in human tumours. The product has been approved in Switzerland in combination with vemurafenib for the treatment of patients with unresectable or metastatic BRAF V600 mutation-positive melanoma, and is under regulatory review for the same indication in several countries, including the USA and the EU. This article summarizes the milestones in the development of cobimetinib leading to this first approval for unresectable or metastatic BRAF V600 mutation-positive melanoma melanoma. PMID:26452567

  2. Brexpiprazole: First Global Approval.

    PubMed

    Greig, Sarah L

    2015-09-01

    Brexpiprazole (Rexulti®) is an atypical antipsychotic that has been developed by Otsuka Pharmaceutical Co. Ltd and H. Lundbeck A/S as an oral treatment for several psychiatric disorders. Brexpiprazole is a novel serotonin-dopamine activity modulator that acts as a partial agonist of serotonin 1A (5-HT1A) and dopamine D2 receptors, as well as a potent antagonist of 5-HT2A receptors and noradrenergic α1B and α2C receptors. In July 2015, brexpiprazole received its first approval in the USA for use as an adjunctive treatment of major depressive disorder (MDD) and the treatment of schizophrenia. In several countries, brexpiprazole is in development for MDDs, schizophrenia, post-traumatic stress disorder and agitation in patients with dementia of the Alzheimer's type. This article summarizes the milestones in the development of brexpiprazole leading to its first global approval in MDD and schizophrenia. PMID:26310190

  3. Alirocumab: First Global Approval.

    PubMed

    Markham, Anthony

    2015-09-01

    Alirocumab (Praluent®) is a fully human monoclonal antibody developed by Regeneron Pharmaceuticals and Sanofi that has been approved in the US as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolaemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)-a down regulator of liver low-density lipoprotein (LDL)-receptors-thereby increasing the ability of the liver to bind LDL-cholesterol (LDL-C) and reducing levels of LDL-C in blood. It has been shown to reduce LDL-C levels in patients with hypercholesterolaemia, including HeFH, both as monotherapy and in conjunction with statin therapy. This article summarizes the milestones in the development of alirocumab leading to this first approval. PMID:26370210

  4. Flibanserin: First Global Approval.

    PubMed

    Deeks, Emma D

    2015-10-01

    Flibanserin (Addyi™) is chemically described as a benzimidazole and is being developed by Sprout Pharmaceuticals for the treatment of hypoactive sexual desire disorder (HSDD). The drug has a high affinity for serotonin 5-HT1A and 5-HT2A receptors (5-HT1A agonist/5-HT2A antagonist) and is believed to treat HSDD by increasing levels of dopamine and noradrenaline and lowering levels of serotonin in the brain. Flibanserin has been approved in the USA for the treatment of premenopausal women with acquired, generalized HSDD. Earlier phase III development of the agent for HSDD in the EU and Canada had been discontinued by Boehringer Ingelheim, following regulatory feedback. Boehringer Ingelheim had also evaluated flibanserin for the treatment of depression but, due to displaying very mild antidepressant activity, its development in this indication was discontinued. This article summarizes the milestones in the development of flibanserin leading to its first approval for HSDD. PMID:26412054

  5. Selexipag: First Global Approval.

    PubMed

    Scott, Lesley J

    2016-03-01

    Selexipag (Uptravi(®)) is a highly selective, long-acting, nonprostanoid, prostacyclin receptor agonist that is being developed by Actelion Pharmaceuticals Ltd and Nippon Shinyaku. Oral selexipag is approved in the USA for the treatment of pulmonary arterial hypertension (PAH; WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. It has subsequently been approved in Canada for the long-term treatment of PAH, and received a positive opinion in the EU for the treatment of PAH in adult patients with WHO functional class II-III. Selexipag received orphan drug designation for the treatment of PAH in Japan in 2014 and is in undergoing regulatory review in several countries for use in this indication. In the large, event-driven, phase III GRIPHON trial, selexipag reduced the risk of the primary composite endpoint of death or a complication related to PAH (whichever occurred first) by 40 % compared with placebo in patients with PAH (80 % were also receiving stable dosages of an endothelin receptor antagonist and/or a phosphodiesterase 5 inhibitor). This article summarizes the milestones in the development of selexipag leading to this first approval for PAH. PMID:26846322

  6. Osimertinib: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-02-01

    Osimertinib (Tagrisso(™), AZD9291) is an oral, third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that is being developed by AstraZeneca for the treatment of advanced non-small cell lung cancer (NSCLC). Osimertinib has been designed to target the EGFR T790M mutation that is often present in NSCLC patients with acquired EGFR TKI resistance, while sparing wild-type EGFR. In November 2015, the tablet formulation of osimertinib was granted accelerated approval in the USA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC (as detected by an FDA-approved test) who have progressed on or after EGFR TKI therapy. Osimertinib has also been granted accelerated assessment status for this indication in the EU, and is in phase III development for first- and second-line and adjuvant treatment of advanced EGFR mutation-positive NSCLC in several countries. Phase I trials in patients with advanced solid tumours are also being conducted. This article summarizes the milestones in the development of osimertinib leading to this first approval for NSCLC. PMID:26729184

  7. Tasimelteon: first global approval.

    PubMed

    Dhillon, Sohita; Clarke, Madeleine

    2014-03-01

    Tasimelteon (HETLIOZ™) is an orally bioavailable agonist of the melatonin MT1 and MT2 receptors that has been approved in the US for the treatment of non-24-hour sleep-wake disorder. It is the first US FDA-approved medication for this orphan indication. Melatonin is thought to play a role in governing the body's natural sleep-wake cycle through physiological processes regulated in the suprachiasmatic nucleus of the hypothalamus. The hormone is secreted by the pineal gland, with onset typically occurring when daylight begins to dim. In healthy, sighted individuals, the endogenous circadian period is a little over 24 hours, but is entrained to the 24-hour day through exposure to environmental cues, such as light and darkness. In the absence of these cues, synchronisation is lost and the circadian rhythm follows the intrinsic non-24-hour clock, resulting in disorders like non-24-hour sleep-wake disorder. Because the rhythm of endogenous melatonin is considered to be a measure of the human circadian phase, the carefully timed administration of melatonin analogues, such as tasimelteon, can potentially promote circadian readjustment. This article summarizes the milestones in the development of tasimelteon leading to this first approval for the treatment of non-24-hour sleep-wake disorder. PMID:24610704

  8. Vortioxetine: first global approval.

    PubMed

    Gibb, Andrew; Deeks, Emma D

    2014-01-01

    Vortioxetine is an orally administered small molecule developed by Lundbeck A/S for the once-daily treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD). Vortioxetine received its first global approval for MDD in the USA in September 2013 and regulatory approval for its use in this indication in the EU (where it has received a positive opinion) and Canada is awaited. The drug is a bis-aryl-sulphanyl amine compound that combines serotonin (5-HT) reuptake inhibition with other characteristics, including receptor activity modulation. In vitro studies indicate that vortioxetine is an inhibitor of the 5-HT transporter and is a 5-HT(1D), 5-HT₃ and 5-HT₇ receptor antagonist, a 5-HT(1A) receptor agonist and a 5-HT(1B) receptor partial agonist. Animal and in vitro studies indicate that several neurotransmitter systems may be impacted by vortioxetine, with the drug enhancing levels of 5-HT, noradrenaline, dopamine, acetylcholine and histamine in certain areas of the brain, as well as modulating γ-aminobutyric acid and glutamate neurotransmission. Phase III trials of vortioxetine in both MDD and GAD have been conducted worldwide. This article summarizes the milestones in the development of vortioxetine leading to this first approval for MDD. PMID:24311349

  9. Dietary supplements in sport.

    PubMed

    Burke, L M; Read, R S

    1993-01-01

    Studies of the dietary practices of athletes report that nutritional supplements are commonly used. Supplementation practices vary between sports and individual athletes; however, there is evidence that at least some athletes use a large number of supplements concurrently, often in doses that are very high in comparison with normal dietary intakes. In exploring supplementation practices we propose a classification system separating the supplements into dietary supplements and nutritional erogogenic aids. The dietary supplement is characterised as a product which can be used to address physiological or nutritional issues arising in sport. It may provide a convenient or practical means of consuming special nutrient requirements for exercise, or it may be used to prevent/reverse nutritional deficiencies that commonly occur among athletes. The basis of the dietary supplement is an understanding of nutritional requirements and physiological effects of exercise. When the supplement is used to successfully meet a physiological/nutritional goal arising in sport it may be demonstrated to improve sports performance. While there is some interest in refining the composition or formulation of some dietary supplements, the real interest belongs to the use or application of the supplement; i.e. educating athletes to understand and achieve their nutritional needs in a specific sports situation. The sports drink (carbohydrate-electrolyte replacement drink) is a well known example of a dietary supplement. Scientific attitudes towards the sports drink have changed over the past 20 years. Initial caution that carbohydrate-electrolyte fluids compromise gastric emptying during exercise has now been shown to be unjustified. Numerous studies have shown that 5 to 10% solutions of glucose, glucose polymers (maltodextrins) and other simple sugars all have suitable gastric emptying characteristics for the delivery of fluid and moderate amounts of carbohydrate substrate. The optimal

  10. Supplemental design requirements document, Project W026. Revision 3

    SciTech Connect

    Weidert, J.R.

    1993-10-08

    This document supplements and extends the Functional Design Criteria, SP-W026-FDC-001, for the Waste Receiving and Processing Facility (WRAP), Module 1. It provides additional detailed requirements, summarizes key Westinghouse Hanford Company design guidance, and establishes baseline technical agreements to be used in definitive design of the WRAP-1 facility. Revision 3 of the Supplemental Design Requirements Document has been assigned an Impact Level of 3ESQ based on the content of the entire revision. The actual changes made from Revision 2 have an Impact Level of 3S and the basis for these changes was previously reviewed and approved per WHC correspondence No. 9355770.

  11. 32 CFR 651.24 - Supplemental EAs and supplemental EISs.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Supplemental EAs and supplemental EISs. As detailed in § 651.5(g) and in 40 CFR 1502.9(c), proposed actions may... 32 National Defense 4 2011-07-01 2011-07-01 false Supplemental EAs and supplemental EISs. 651.24 Section 651.24 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY...

  12. 32 CFR 651.24 - Supplemental EAs and supplemental EISs.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Supplemental EAs and supplemental EISs. As detailed in § 651.5(g) and in 40 CFR 1502.9(c), proposed actions may... 32 National Defense 4 2014-07-01 2013-07-01 true Supplemental EAs and supplemental EISs. 651.24 Section 651.24 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY...

  13. 32 CFR 651.24 - Supplemental EAs and supplemental EISs.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Supplemental EAs and supplemental EISs. As detailed in § 651.5(g) and in 40 CFR 1502.9(c), proposed actions may... 32 National Defense 4 2010-07-01 2010-07-01 true Supplemental EAs and supplemental EISs. 651.24 Section 651.24 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY...

  14. 32 CFR 651.24 - Supplemental EAs and supplemental EISs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Supplemental EAs and supplemental EISs. As detailed in § 651.5(g) and in 40 CFR 1502.9(c), proposed actions may... 32 National Defense 4 2013-07-01 2013-07-01 false Supplemental EAs and supplemental EISs. 651.24 Section 651.24 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY...

  15. 32 CFR 651.24 - Supplemental EAs and supplemental EISs.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Supplemental EAs and supplemental EISs. As detailed in § 651.5(g) and in 40 CFR 1502.9(c), proposed actions may... 32 National Defense 4 2012-07-01 2011-07-01 true Supplemental EAs and supplemental EISs. 651.24 Section 651.24 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY...

  16. Review of nutritional supplements for the treatment of bipolar depression.

    PubMed

    Rakofsky, Jeffrey J; Dunlop, Boadie W

    2014-05-01

    Many patients view psychotropics with skepticism and fear and view nutritional supplements as more consistent with their values and beliefs. The purpose of this review was to critically evaluate the evidence base for nutritional supplements in the treatment of bipolar depression (BD). A literature search for all randomized, controlled clinical trials using nutritional supplements in the treatment of BD was conducted via PubMed and Ovid MEDLINE computerized database. The studies were organized into essential nutrients/minerals, nonessential nutrients, and combinations of nutritional products. Among essential nutrients/minerals, omega-3-fatty acids (O3FAs) have the strongest evidence of efficacy for bipolar depression, although some studies failed to find positive effects from O3FAs. Weak evidence supports efficacy of vitamin C whereas no data support the usefulness of folic acid and choline. Among nonessential nutrients, cytidine is the least supported treatment. Studies of N-acetylcysteine have not resolved its efficacy in treating acute depressive episodes relative to placebo. However, one study demonstrates its potential to improve depressive symptoms over time and the other, though nonsignificant, suggests it has a prophylactic effect. Studies of inositol have been mostly negative, except for 1 study. Those that were negative were underpowered but demonstrated numerically positive effects for inositol. There is no evidence that citicholine is efficacious for uncomplicated BD depression, though it may have value for comorbid substance abuse among BD patients. Finally, combination O3FA-cytidine lacks evidence of efficacy. The findings of this review do not support the routine use of nutritional supplements in the treatment or prophylaxis of BD depression. Studies with more rigorous designs are required before definitive conclusions can be made. Despite the inadequacy of the existing data, clinicians should remain open to the value of nutritional supplements: after

  17. Vitamin B supplementation for diabetic peripheral neuropathy

    PubMed Central

    Jayabalan, Bhavani; Low, Lian Leng

    2016-01-01

    Vitamin B12 deficiency has been associated with significant neurological pathology, especially peripheral neuropathy. This review aims to examine the existing evidence on the effectiveness of vitamin B12 supplementation for the treatment of diabetic peripheral neuropathy. A search of PubMed and the Cochrane Central Register of Controlled Trials for all relevant randomised controlled trials was conducted in December 2014. Any type of therapy using vitamin B12 or its coenzyme forms was assessed for efficacy and safety in diabetics with peripheral neuropathy. Changes in vibration perception thresholds, neuropathic symptoms and nerve conduction velocities, as well as the adverse effects of vitamin B12 therapy, were assessed. Four studies comprising 363 patients met the inclusion criteria. This review found no evidence that the use of oral vitamin B12 supplements is associated with improvement in the clinical symptoms of diabetic neuropathy. Furthermore, the majority of studies reported no improvement in the electrophysiological markers of nerve conduction. PMID:26892473

  18. Herbal Products and Supplements

    MedlinePlus

    ... and prescription medicines just because they come from nature. Although herbal health products and supplements are advertised as “natural,” their ingredients aren’t necessarily natural to the human body. They may have strong effects on your ...

  19. Supplements to Textbook Materials.

    ERIC Educational Resources Information Center

    Holmes, Ken

    1994-01-01

    Describes the many kinds of materials that English teachers can draw upon to enrich and expand students' experiences with literature. Outlines ancillary materials used to supplement the study of William Shakespeare's "Julius Caesar." (HB)

  20. FDA 101: Dietary Supplements

    MedlinePlus

    ... professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, ... the address or phone number listed on the product's label. Dietary supplement firms are required to forward reports ...

  1. Using Dietary Supplements Wisely

    MedlinePlus

    ... as diabetes, cancer, or cardiovascular disease. Sources of Science-Based Information It’s important to look for reliable ... e-mail Email Address Related Topics Know the Science: How Medications and Supplements Can Interact Safe Use ...

  2. Vitamin supplementation in pregnancy.

    PubMed

    2016-07-01

    Ensuring that a woman is well-nourished, both before and during pregnancy, is crucial for the health of the woman and that of the unborn child.(1) Maternal deficiency in key nutrients has been linked to pre-eclampsia, restricted fetal growth, neural tube defects, skeletal deformity and low birth weight.(1,2) Many nutritional supplements containing vitamins, minerals and other micronutrients are heavily marketed to women for all stages of pregnancy. However, much of the evidence for vitamin supplementation in pregnancy comes from studies carried out in low-income countries,(3) where women are more likely to be undernourished or malnourished than within the UK population. The challenges lie in knowing which supplements are beneficial and in improving uptake among those at most need. Here we summarise current UK guidance for vitamin supplementation in pregnancy and review the evidence behind it. PMID:27405305

  3. Breastfeeding: Vitamin D Supplementation

    MedlinePlus

    ... Breastfeeding Micronutrient Malnutrition State and Local Programs Vitamin D Supplementation Recommend on Facebook Tweet Share Compartir While ... provide infants with an adequate intake of vitamin D. Most breastfed infants are able to synthesize additional ...

  4. Dietary Supplements for Toddlers

    MedlinePlus

    ... about which supplements are needed and the amounts. Iron Deficiency Iron deficiency does occur among some young children and ... need to receive at least 15 milligrams of iron a day in their food, but many fail ...

  5. Iron supplements (image)

    MedlinePlus

    The mineral iron is an essential nutrient for humans because it is part of blood cells, which carry oxygen to all body cells. There is no conclusive evidence that iron supplements contribute to heart attacks.

  6. The dilemma of approving antidotes.

    PubMed

    Steffen, Christian

    2007-04-20

    Clinical trials with antidotes are difficult to perform for a variety of practical, ethical, and financial reasons. As acute poisoning is a rare event, the commercial interest in basic and clinical research is low. Poisoned patients are usually not available for normal clinical trial procedures and, if they are, they cannot give informed consent. This situation results in a dilemma: antidotes are essential drugs. A resolution of the Council of Europe requests to guarantee the optimal availability of antidotes and the improvement of their use. As comprehensive data on the efficacy of antidotes are often missing, a marketing authorisation under exceptional circumstances according to Article 14(8) of Regulation (EC) No. 276/2004, will often be the only way to get an approval, as: (1) the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence ("orphan drug"), (2) in the present state of scientific knowledge, comprehensive information cannot be provided, or (3) it would be contrary to generally accepted principles of medical ethics to collect such data. Typically, data on antidotes are obtained from a patchwork of studies with animals, human tissue and a few observations from human poisoning corroborated with data from clinical observations and biochemistry. Generalisations from chemical and mechanistic similarities between groups of poisons are usual, but often lack scientific evidence. Current standards of good clinical practice can rarely be observed. Therefore, public funding and other financial support are necessary incentives to initiate trials in this important area. PMID:17207900

  7. Review: Evidence-based Clinical Research of Anti-obesity Supplements in Japan

    PubMed Central

    Yasueda, Asuka; Ito, Toshinori; Maeda, Kazuhisa

    2013-01-01

    Background: The prevalence of obesity has increased dramatically throughout the world, and weight reduction through lifestyle management is urgently warranted. At present, numerous supplements advertised for their anti-overweight property are available in the Japanese market, but most of these lack proper evidence. Thus, we investigated dietary supplements that have been tested in clinical trials. Search Strategy: We researched anti-obesity supplements in the Japanese market using the google search engine in Japanese with the key terms “anti-obesity supplements,” ”diet supplements,” and “weight reduction supplements.” Results: We listed 49 companies that supply anti-obesity supplements. Of these, 11 had published clinical evidence of the anti-obesity efficacy of their supplements. These products contain the following active ingredients: Angelica keiskei, bofu-tsusho-san, capsaishin, DHA/EPA, forskohlii, garcinia cambogia, lactoferrin, L-carnitine, oligonol, tea catechin, and yeast hydrolysate. Conclusion: We obtained 11 supplements for which clinical evidence was published in medical journals in English. We also found 10 products for which clinical or animal evidence was published in Japanese. We expect that many companies will produce evidence of the efficacy of their products in the near future, thereby validating the use of dietary anti-obesity supplements in Japan. PMID:26005506

  8. Ethical considerations in orphan drug approval and use.

    PubMed

    Kesselheim, A S

    2012-08-01

    The Orphan Drug Act seeks to meet a utilitarian goal of advancing therapeutic options for patients with rare diseases. However, data show that orphan drugs are often approved with more limited premarket testing than that carried out for nonorphan drugs and consequently expose patients to more risk and less certain efficacy. Therefore, the ethical principles of justice and beneficence may require attention to informed consent among patients receiving the drugs and greater investment in postmarket surveillance and confirmational testing. PMID:22814660

  9. Lesinurad: First Global Approval.

    PubMed

    Hoy, Sheridan M

    2016-03-01

    Lesinurad (ZURAMPIC(®)) is an oral urate-anion exchanger transporter 1 (URAT1) inhibitor developed by Ardea Biosciences (a subsidiary of AstraZeneca) for the treatment of hyperuricaemia associated with gout. It reduces serum uric acid (sUA) levels by inhibiting the function of the transporter proteins (URAT1 and organic anion transporter 4) involved in uric acid reabsorption in the kidney. In December 2015, lesinurad was approved in the USA as combination therapy with a xanthine oxidase inhibitor for the treatment of hyperuricaemia associated with gout in patients who have not achieved sUA target levels with a xanthine oxidase inhibitor alone. Lesinurad has also received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for this indication and is in phase III development as a combination therapy in several other countries. This article summarizes the milestones in the development of lesinurad leading to this first approval for hyperuricaemia associated with gout. PMID:26861027

  10. Necitumumab: First Global Approval.

    PubMed

    Garnock-Jones, Karly P

    2016-02-01

    Eli Lilly is developing necitumumab (Portrazza™), an intravenously administered fully human IgG monoclonal antibody directed against the epidermal growth factor receptor (EGFR), which is expressed in a variety of solid tumours and has been implicated in promoting oncogenesis and tumour progression. Necitumumab is approved as a part of combination therapy (with gemcitabine and cisplatin) in the USA for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC), and regulatory submissions have been made in the EU for this same indication. Necitumumab was derived from the proprietary phage display library of Dyax Corp, and originated with ImClone Systems, which was acquired by Eli Lilly in November 2008. Necitumumab was also under phase II development for colorectal cancer in Belgium and Spain; however, no recent development has been reported for this indication. This article summarizes the milestones in the development of necitumumab leading to this first approval for the first-line treatment of metastatic squamous NSCLC, in combination with gemcitabine and cisplatin. PMID:26729188

  11. Dinutuximab: first global approval.

    PubMed

    Dhillon, Sohita

    2015-05-01

    United Therapeutics Corporation and the National Cancer Institute are developing dinutuximab (Unituxin™; ch14.18), a monoclonal antibody targeting GD2, for the treatment of neuroblastoma. GD2 is a glycolipid found on the surface of tumour cells, which is overexpressed in neuroblastoma. Dinutuximab, an IgG1 human/mouse chimeric switch variant of murine monoclonal antibody 14G2a, binds to GD2 and induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity. The US FDA has recently approved the use of dinutuximab combination therapy for the treatment of high-risk neuroblastoma in paediatric patients. The marketing authorization application for dinutuximab is under regulatory review in the EU, and phase I-III development is underway in several other countries. This article summarizes the milestones in the development of dinutuximab leading to this first approval for use (in combination with granulocyte macrophage colony-stimulating factor, interleukin-2 and 13-cis retinoic acid) in the treatment of paediatric patients with high-risk neuroblastoma who achieve at least partial response to prior first-line multiagent, multimodality therapy. PMID:25940913

  12. Sonidegib: First Global Approval.

    PubMed

    Burness, Celeste B

    2015-09-01

    Sonidegib (Odomzo™) is an orally bioavailable, small molecule, Smoothened (SMO) receptor antagonist that is being developed by Novartis for the treatment of cancer. SMO is a G protein-coupled receptor-like molecule that is essential for the actions of the Hedgehog family of secreted proteins, which play a critical role in the development and homeostasis of many organs and tissues. Oral sonidegib is approved in Switzerland for the treatment of adult patients with advanced basal cell carcinoma (BCC) and in the US and EU for the treatment of adult patients with locally advanced BCC that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Submissions to other global authorities are being contemplated or planned. Additionally, phase I/II investigation is being conducted in other malignancies, including multiple myeloma, medulloblastoma, myelofibrosis, ovarian cancer, prostate cancer, breast cancer, chronic myeloid leukaemia, myelodysplastic syndromes, oesophageal cancer and pancreatic cancer. This article summarizes the milestones in the development of sonidegib leading to the first approvals for advanced and locally advanced BCC. PMID:26323341

  13. Ixazomib: First Global Approval.

    PubMed

    Shirley, Matt

    2016-03-01

    Ixazomib (Ninlaro(®)) is an orally bioavailable, reversible proteasome inhibitor developed by Millennium Pharmaceuticals, Inc. (now Takeda Oncology). Ixazomib acts by binding to and inhibiting the β5 subunit of the 20S proteasome. In November 2015, the US FDA approved ixazomib for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib is under regulatory review for this indication in the EU. Phase III development of ixazomib is underway worldwide for newly-diagnosed multiple myeloma (in patients who are not eligible for stem cell transplant, or as maintenance therapy) and for relapsed or refractory systemic light chain (AL) amyloidosis. Ixazomib is also under phase I-II development for the treatment of several other haematological and non-haematological malignancies, graft-versus-host disease and lupus nephritis. This article summarizes the milestones in the development of ixazomib leading to this first approval for multiple myeloma. PMID:26846321

  14. Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems.

    PubMed

    Walter, Jessica R; Hayman, Emily; Tsai, Shelun; Ghobadi, Comeron W; Xu, Shuai

    2016-06-01

    Recent controversies surrounding obstetrics and gynecology devices, including a permanent sterilization device, pelvic meshes, and laparoscopic morcellators, highlight the need for deeper understanding of obstetrics and gynecology medical device regulation. The U.S. Food and Drug Administration premarket approval database was queried for approvals assigned to the obstetrics and gynecology advisory committee from January 2000 to December 2015. Eighteen device approvals occurred in the time period studied. The most common clinical indications included endometrial ablation (33%), contraception (28%), and fetal monitoring (17%). The median approval time was 290 days (range 178-1,399 days). Regarding the pivotal trials leading to approval, there were 11 randomized controlled trials, one randomized crossover study, five nonrandomized prospective studies, and two human factor studies. Fourteen devices (78%) met their primary clinical efficacy endpoint. Only 12 of 18 devices were required to conduct postmarket surveillance. A significant proportion of devices (42%) were approved on the basis of nonrandomized controlled trials. Three devices have been withdrawn after approval, all of which were either not referred or not recommended for approval by the obstetrics and gynecology advisory committee. Of the three devices withdrawn from the market, two failed to demonstrate clinical benefit in their pivotal trials. One device was not required to undergo postmarketing surveillance and was subsequently withdrawn as a result of patient safety concerns. Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices. PMID:27159747

  15. CLSI performance standards for antimicrobial susceptibility testing of bacteria isoloated from aquatic animals; second information supplement. CLSI document VET03/VET04-S2

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The supplemental information presented in this document is intended for use with the antimicrobial susceptibility testing procedures published in the following Clinical and Laboratory Standards Institute (CLSI) approved documents VET03-A Methods for Antimicrobial Disk Susceptibility Testing of Bacte...

  16. Premarket Safety and Efficacy Studies for ADHD Medications in Children

    PubMed Central

    Bourgeois, Florence T.; Kim, Jeong Min; Mandl, Kenneth D.

    2014-01-01

    Background Attention-deficit hyperactivity disorder (ADHD) is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing. Methods We identified all ADHD medications approved by the Food and Drug Administration (FDA) and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug’s clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials. Results A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419). Eleven drugs (55%) were approved after <100 participants were studied and 14 (70%) after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9), with 5 (38%) drugs approved after participants were studied <4 weeks and 10 (77%) after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed. Conclusions Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved. PMID:25007171

  17. 76 FR 1525 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Revisions to Rules and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-11

    ...EPA is taking final action to partially approve and partially disapprove revisions of the Texas State Implementation Plan (SIP) submitted by the Texas Commission on Environmental Quality (TCEQ, or Commission) on January 3, 2000, and July 31, 2002, as supplemented on August 5, 2009. These revisions are to regulations of the TCEQ that relate to application and permitting procedures for......

  18. 76 FR 28971 - Atlanta Gas Light Company; Notice of Petition for Rate Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-19

    ... Federal Energy Regulatory Commission Atlanta Gas Light Company; Notice of Petition for Rate Approval Take notice that on May 9, 2011, as supplemented on May 11, 2011, Atlanta Gas Light Company (Atlanta Gas Light... for transportation service. Atlanta Gas Light states the rate election consists of the maximum...

  19. 20 CFR 416.1225 - An approved plan to achieve self-support; general.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false An approved plan to achieve self-support; general. 416.1225 Section 416.1225 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... achieve self-support; general. If you are blind or disabled, we will pay you SSI benefits and will...

  20. 78 FR 19714 - User Fees and Refunds for Premarket Approval Applications and Device Biologics License...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``User Fees and Refunds for Premarket Approval Applications (PMAs) and Device Biologics License Applications (BLAs).'' The purpose of this guidance document is to identify the types of PMAs and BLAs subject to device user fees, including supplements and other submissions, as well as those that do not......

  1. 14 CFR 121.555 - Compliance with approved routes and limitations: Domestic and flag operations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... limitations: Domestic and flag operations. 121.555 Section 121.555 Aeronautics and Space FEDERAL AVIATION...: CERTIFICATION AND OPERATIONS OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Flight Operations § 121.555 Compliance with approved routes and limitations: Domestic and flag operations. No...

  2. 14 CFR 121.555 - Compliance with approved routes and limitations: Domestic and flag operations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... limitations: Domestic and flag operations. 121.555 Section 121.555 Aeronautics and Space FEDERAL AVIATION...: CERTIFICATION AND OPERATIONS OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Flight Operations § 121.555 Compliance with approved routes and limitations: Domestic and flag operations. No...

  3. 14 CFR 121.555 - Compliance with approved routes and limitations: Domestic and flag operations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... limitations: Domestic and flag operations. 121.555 Section 121.555 Aeronautics and Space FEDERAL AVIATION...: CERTIFICATION AND OPERATIONS OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Flight Operations § 121.555 Compliance with approved routes and limitations: Domestic and flag operations. No...

  4. 14 CFR 121.555 - Compliance with approved routes and limitations: Domestic and flag operations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... limitations: Domestic and flag operations. 121.555 Section 121.555 Aeronautics and Space FEDERAL AVIATION...: CERTIFICATION AND OPERATIONS OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Flight Operations § 121.555 Compliance with approved routes and limitations: Domestic and flag operations. No...

  5. 76 FR 77903 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-15

    ... action published on October 21, 2011 (76 FR 65458), EPA proposed approval of Kentucky's plan for..., proposal. \\1\\ On September 29, 2011, at 76 FR 60373, EPA determined that the Tri-state Cincinnati-Hamilton... finalized on January 5, 2005 (70 FR 944), and as supplemented on April 14, 2005 (70 FR 19844). EPA...

  6. 5 CFR 4501.103 - Prior approval for certain outside activities.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... activities. 4501.103 Section 4501.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OFFICE OF PERSONNEL MANAGEMENT § 4501.103 Prior approval... fundraising support through the Combined Federal Campaign (CFC) under 5 CFR part 950 and the...

  7. 5 CFR 4501.103 - Prior approval for certain outside activities.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... activities. 4501.103 Section 4501.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OFFICE OF PERSONNEL MANAGEMENT § 4501.103 Prior approval... fundraising support through the Combined Federal Campaign (CFC) under 5 CFR part 950 and the...

  8. 14 CFR 121.555 - Compliance with approved routes and limitations: Domestic and flag operations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... limitations: Domestic and flag operations. 121.555 Section 121.555 Aeronautics and Space FEDERAL AVIATION...: CERTIFICATION AND OPERATIONS OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Flight Operations § 121.555 Compliance with approved routes and limitations: Domestic and flag operations. No...

  9. 78 FR 48323 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update of the Motor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-08

    ... the point source inventory for NO X and VOCs. On July 18, 1997 (62 FR 38856), EPA established the 1997 8-Hour Ozone NAAQS. On April 30, 2004 (69 FR 23857), Lancaster County was designated as... supplemented their September 20, 2006 submittal. On July 6, 2007 (72 FR 36889), EPA approved the SIP...

  10. 78 FR 18973 - Bridgeline Holdings, L.P.; Notice of Petition for Rate Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-28

    ... Energy Regulatory Commission Bridgeline Holdings, L.P.; Notice of Petition for Rate Approval Take notice that on February 28, 2013, as supplemented on March 12, 2013, Bridgeline Holdings, L.P. filed for... free). For TTY, call (202) 502-8659. Comment Date: 5:00 p.m. Eastern Time on Monday, April 1,...

  11. 76 FR 73955 - Approval and Promulgation of Air Quality Implementation Plans; Maine; Regional Haze

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-29

    ...EPA is proposing approval of a revision to the Maine State Implementation Plan (SIP) submitted by the Maine Department of Environmental Protection (Maine DEP) on December 9, 2010, with supplemental submittals on September 14, 2011 and November 9, 2011, that addresses regional haze for the first planning period from 2008 through 2018. This revision addresses the requirements of the Clean Air......

  12. 76 FR 70078 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... Particulate Matter and Ozone in 27 States; Correction of SIP Approvals for 22 States'' (76 FR 48208, August 8... FR 61144, EPA retained the annual average NAAQS at 15.0 g/m\\3\\ but revised the 24-hour NAAQS to 35 g... remanded 2006 Annual NAAQS. On January 5, 2005, at 70 FR 944, and supplemented on April 14, 2005, at 70...

  13. 40 CFR 52.1019 - Identification of plan-conditional approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Identification of plan—conditional approval. (a) 1997 PM2.5 NAAQS: The SIP submitted September 10, 2008, with a... committed to in letters from the state to EPA Region 1 dated June 13, 2012, and June 30, 2012. (b) 2006 PM2.5 NAAQS: The SIP submitted July 27, 2009, with a supplement submitted on June 1, 2011,...

  14. 40 CFR 52.1019 - Identification of plan-conditional approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Identification of plan—conditional approval. (a) 1997 PM2.5 NAAQS: The SIP submitted September 10, 2008, with a... committed to in letters from the state to EPA Region 1 dated June 13, 2012, and June 30, 2012. (b) 2006 PM2.5 NAAQS: The SIP submitted July 27, 2009, with a supplement submitted on June 1, 2011,...

  15. 42 CFR 403.222 - State with an approved regulatory program.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false State with an approved regulatory program. 403.222 Section 403.222 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS SPECIAL PROGRAMS AND PROJECTS Medicare Supplemental Policies State...

  16. 42 CFR 403.222 - State with an approved regulatory program.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 2 2014-10-01 2014-10-01 false State with an approved regulatory program. 403.222 Section 403.222 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS SPECIAL PROGRAMS AND PROJECTS Medicare Supplemental Policies State...

  17. Nutritional supplements and the EU: is anyone happy?

    PubMed

    Eberhardie, Christine

    2007-11-01

    In 2000 an estimated pound sterling 335 x 106 was spent on food supplements and herbal remedies in the UK. Until recently, The Trades Description Act 1968, the Food Safety Act 1990 and The Food Labelling Regulations 1996 (amended 2004) were the only form of regulation available to protect the public. The medical community has been concerned about the risk to patients of inaccurate dosages and poor-quality products as well as drug-nutrient and nutrient-nutrient interactions. Following growing concern about the type and quality of food supplements and herbal remedies available in the EU, the European Commission has published directives regulating food supplements (2002/46/EC) and herbal remedies (2004/24/EC and 2004/27/EC) available within the EU. The directives came into force in 2005 and limit the number and quality of permitted food supplements through the creation of a 'positive list' of approved supplements. In the present paper the new regulatory frameworks and the implications for the food supplement manufacturers, traditional and complementary therapists, the healthcare professions and patients will be examined. It would appear that there is considerable dissatisfaction with the regulations in their present form. Several questions remain: is regulation the answer; who decides which nutrients go on the positive list; what effect has the regulation had on patient safety and patient choice? PMID:17961271

  18. Dietary Supplementation with Olive Oil or Fish Oil and Vascular Effects of Concentrated Ambient Particulate Matter Exposure in Human Volunteers

    EPA Science Inventory

    Background: Exposure to ambient particulate matter (PM) induces endothelial dysfunction, a risk factor for cardiovascular disease. Olive oil (OO) and fish oil (FO) supplements have beneficial effects on endothelial function. Objective: In this study we evaluated the efficacy of...

  19. DIETARY SUPPLEMENTATION WITH BLUEBERRY EXTRACTS IMPROVES THE SURVIVAL AND FUNCTION OF GRAFTED EMBRYONIC DOPAMINE NEURONS IN RATS

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Transplantation of embryonic dopamine (DA) neurons into the striatum is a viable treatment for Parkinson's disease (PD). However, transplanted cells survive poorly. This study provides evidence that dietary supplementation with blueberry extract (BBE) provides an efficacious, easily administered a...

  20. Supplements and sports.

    PubMed

    Jenkinson, David M; Harbert, Allison J

    2008-11-01

    Use of performance-enhancing supplements occurs at all levels of sports, from professional athletes to junior high school students. Although some supplements do enhance athletic performance, many have no proven benefits and have serious adverse effects. Anabolic steroids and ephedrine have life-threatening adverse effects and are prohibited by the International Olympic Committee and the National Collegiate Athletic Association for use in competition. Blood transfusions, androstenedione, and dehydroepiandrosterone are also prohibited in competition. Caffeine, creatine, and sodium bicarbonate have been shown to enhance performance in certain contexts and have few adverse effects. No performance benefit has been shown with amino acids, beta-hydroxy-beta-methylbutyrate, chromium, human growth hormone, and iron. Carbohydrate-electrolyte beverages have no serious adverse effects and can aid performance when used for fluid replacement. Given the widespread use of performance-enhancing supplements, physicians should be prepared to counsel athletes of all ages about their effectiveness, safety, and legality. PMID:19007050

  1. A drug's life: the pathway to drug approval.

    PubMed

    Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

    2013-10-01

    In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights. PMID:24518374

  2. Pharmacovigilance on sexual enhancing herbal supplements.

    PubMed

    Bhagavathula, Akshaya Srikanth; Elnour, Asim Ahmed; Shehab, Abdulla

    2016-01-01

    The use of herbal medicines continues to expand rapidly across world and many people show positive interest to use herbal products for their health. The safety of herbal supplements has become a globally major concern in national and international health authorities due to increasing adverse events and adulterations. It is difficult to analyze herbal products that cause adverse events due to lack of sufficient information and expertise. Inadequate regulatory measures, weak quality control system and uncontrolled distribution channels are some of reasons that enhance the informal pharmaceutical market. In recent years, the unfulfilled desire for sex has been a subject that has aroused increasing public interest with respect to improve sexual functions. The use of herbal medicines substantially increased due to escalated prevalence and impact of sexual problems worldwide and estimates predicting the incidence to raise over 320 million by year 2025. The various reasons to use herbal supplements in men may be due to experiencing changes in erectile dysfunction (ED) due to certain medical conditions such as diabetes and hypertension and bodily changes as a normal part of life and aging. There is a lack of adequate evidence, no impetus to evaluate and absence of any regulatory obligations to undertake rigorous testing for safety and efficacy of herbal supplements before they sold over-the-counter (OTC). Pharmacovigilance on herbal supplements is still not well established. Sexual enhancing herbals are on demand in men health but informal adulteration is growing issue of concern. Recently, increase in use of herbal supplements for erectile dysfunction has laid a path for many illegal compositions. This paper explores facts and evidences that were observed in different countries attempting to demonstrate the importance of strengthening regulatory system to strengthen the application of pharmacovigilance principles on sexual enhancing supplements. We hereby explore the

  3. Lead extraction using a laser system: Techniques, efficacy, and limitations.

    PubMed

    Okamura, Hideo

    2016-08-01

    Transvenous lead extraction is becoming popular in Japan since the approval of laser extraction system in 2010. The laser system seems to be the standard method used by most physicians, owing to its efficacy and ease of handling. The efficacy and safety of this technology has been well proven in many studies and the data suggest that it can be used for Japanese patients safely. However, lead extraction can cause serious complications. Thus, it is important to learn the limitations as well as the basic techniques and efficacy of this procedure. PMID:27588149

  4. Diet and Psoriasis: Part 3. Role of Nutritional Supplements

    PubMed Central

    Millsop, Jillian W.; Bhatia, Bhavnit K.; Debbaneh, Maya; Koo, John; Liao, Wilson

    2014-01-01

    Psoriasis patients are increasingly turning to the use of alternative and complementary medicine to manage their psoriasis. Patients often inquire about what dietary supplements may be beneficial, including the use of oral vitamin D, vitamin B12, selenium, and omega-3 fatty acids in fish oils. In this review we examine the extent to which each of these common nutritional interventions has been studied for the treatment of psoriasis. We weighed evidence from both controlled and uncontrolled prospective trials. The evidence of benefit was highest for fish oils. For other supplements, there is need for additional large, randomized clinical trials to establish evidence of efficacy. PMID:24780177

  5. Caffeine and Creatine Content of Dietary Supplements Consumed by Brazilian Soccer Players.

    PubMed

    Inácio, Suelen Galante; de Oliveira, Gustavo Vieira; Alvares, Thiago Silveira

    2016-08-01

    Caffeine and creatine are ingredients in the most popular dietary supplements consumed by soccer players. However, some products may not contain the disclosed amounts of the ingredients listed on the label, compromising the safe usage and the effectiveness of these supplements. Therefore, the aim of this study was to evaluate the content of caffeine and creatine in dietary supplements consumed by Brazilian soccer players. The results obtained were compared with the caffeine content listed on the product label. Two batches of the supplement brands consumed by ≥ 50% of the players were considered for analysis. The quantification of caffeine and creatine in the supplements was determined by a high-performance liquid chromatography system with UV detector. Nine supplements of caffeine and 7 supplements of creatine met the inclusion criteria for analysis. Eight brands of caffeine and five brands of creatine showed significantly different values (p < .05) as compared with the values stated on the label. There were no significant differences between the two batches of supplements analyzed, except for one caffeine supplement. It can be concluded that caffeine and creatine dietary supplements consumed by Brazilian soccer players present inaccurate values listed on the label, although most presented no difference among batches. To ensure consumer safety and product efficacy, accurate information on caffeine and creatine content should be provided on all dietary supplement labels. PMID:26696650

  6. Supplement use by Young Athletes

    PubMed Central

    McDowall, Jill Anne

    2007-01-01

    This paper reviews studies of supplement use among child and adolescent athletes, focusing on prevalence and type of supplement use, as well as gender comparisons. Supplement use among adult athletes has been well documented however there are a limited number of studies investigating supplement use by child and adolescent athletes. A trend in the current literature revealed that the most frequently used supplements are in the form of vitamin and minerals. While health and illness prevention are the main reasons for taking supplements, enhanced athletic performance was also reported as a strong motivating factor. Generally, females are found to use supplements more frequently and are associated with reasons of health, recovery, and replacing an inadequate diet. Males are more likely to report taking supplements for enhanced performance. Both genders equally rated increased energy as another reason for engaging in supplement use. Many dietary supplements are highly accessible to young athletes and they are particularly vulnerable to pressures from the media and the prospect of playing sport at increasingly elite levels. Future research should provide more direct evidence regarding any physiological side effects of taking supplements, as well as the exact vitamin and mineral requirements for child and adolescent athletes. Increased education for young athletes regarding supplement use, parents and coaches should to be targeted to help the athletes make the appropriate choices. Key pointsSupplement use among the child and adolescent athlete population is widespread with the most frequently used supplement being a form of vitamin/mineral supplement.The effects of supplement use on the growth and development of children and adolescents remain unclear and thus use of supplements by this population should be discouraged.It is likely that there is a misunderstanding as to the role of vitamins and minerals in the diet, their function in maintaining overall health, their role

  7. Popular sports supplements and ergogenic aids.

    PubMed

    Juhn, Mark

    2003-01-01

    This article reviews the evidence-based ergogenic potential and adverse effects of 14 of the most common products in use by recreational and elite athletes today. Both legal and prohibited products are discussed. This is an aggressively marketed and controversial area of sports medicine worldwide. It is therefore prudent for the clinician to be well versed in the more popular supplements and drugs reputed to be ergogenic in order to distinguish fact from fiction.Antioxidants, proteins and amino acids are essential components of diet, but additional oral supplementation does not increase endurance or strength. Caffeine is ergogenic in certain aerobic activities. Creatine is ergogenic in repetitive anaerobic cycling sprints but not running or swimming. Ephedrine and pseudoephedrine may be ergogenic but have detrimental cardiovascular effects. Erythropoietin is ergogenic but increases the risk of thromboembolic events. beta-Hydroxy-beta-methylbutyrate has ergogenic potential in untrained individuals, but studies are needed on trained individuals. Human growth hormone and insulin growth factor-I decrease body fat and may increase lean muscle mass when given subcutaneously. Pyruvate is not ergogenic. The androgenic precursors androstenedione and dehydroepiandrosterone have not been shown to increase any parameters of strength and have potentially significant adverse effects. Anabolic steroids increase protein synthesis and muscle mass but with many adverse effects, some irreversible. Supplement claims on labels of product content and efficacy can be inaccurate and misleading. PMID:12974658

  8. National Athletic Trainers' Association Position Statement: Evaluation of Dietary Supplements for Performance Nutrition

    PubMed Central

    Buell, Jackie L; Franks, Rob; Ransone, Jack; Powers, Michael E; Laquale, Kathleen M; Carlson-Phillips, Amanda

    2013-01-01

    Objectives To help athletic trainers promote a “food-first” philosophy to support health and performance, understand federal and sport governing body rules and regulations regarding dietary supplements and banned substances, and become familiar with reliable resources for evaluating the safety, purity, and efficacy of dietary supplements. Background The dietary supplement industry is poorly regulated and takes in billions of dollars per year. Uneducated athletes need to gain a better understanding of the safety, eligibility, and efficacy concerns associated with choosing to take dietary supplements. The athletic trainer is a valuable athletic team member who can help in the educational process. In many cases, athletic trainers are asked to help evaluate the legality, safety, and efficacy of dietary supplements. For this position statement, our mission is to provide the athletic trainer with the necessary resources for these tasks. Recommendations Proper nutrition and changes in the athlete's habitual diet should be considered first when improved performance is the goal. Athletes need to understand the level of regulation (or lack thereof) governing the dietary supplement industry at the international, federal, state, and individual sport-participation levels. Athletes should not assume a product is safe simply because it is marketed over the counter. All products athletes are considering using should be evaluated for purity (ie, truth in labeling), safety, and efficacy. PMID:23672334

  9. Psychology: Teacher Supplement.

    ERIC Educational Resources Information Center

    Stark, Rebecca

    This supplement provides teachers with tests, quizzes, answers to questions in the text, and general teaching information for using the student text, "Psychology," by Rebecca Stark. Quizzes included are on the topics of human development; the nervous system; the brain; cognitive development; sensation and perception; conditioning; learning;…

  10. Speechreading with Tactile Supplements.

    ERIC Educational Resources Information Center

    Plant, Geoff

    1988-01-01

    Reviewed is the historical development of tactile aids to supplement speechreading by hearing-impaired individuals, from early use of bone conduction vibrators driven by hearing aids, to multichannel tactile aids representing the full speech spectrum and tactile speechreading aids complementing visual cues. Adequate training in use of tactile…

  11. Supplemental TV Taped Problems.

    ERIC Educational Resources Information Center

    Squires, Robert G.; Frank, David V.

    1983-01-01

    Videotapes were developed as supplemental material for a course in chemical engineering thermodynamics. Describes the course, videotapes produced (includes list by topics as related to course content), and effectiveness of the tapes. Although no significant improvement in test performance was noted, students indicated they learned material faster…

  12. Lead in calcium supplements.

    PubMed

    Scelfo, G M; Flegal, A R

    2000-04-01

    Intercalibrated measurements of lead in calcium supplements indicate the importance of rigorous analytical techniques to accurately quantify contaminant exposures in complex matrices. Without such techniques, measurements of lead concentrations in calcium supplements may be either erroneously low, by as much as 50%, or below the detection limit needed for new public health criteria. In this study, we determined the lead content of 136 brands of supplements that were purchased in 1996. The calcium in the products was derived from natural sources (bonemeal, dolomite, or oyster shell) or was synthesized and/or refined (chelated and nonchelated calcium). The dried products were acid digested and analyzed for lead by high resolution-inductively coupled plasma-mass spectrometry. The method's limit of quantitation averaged 0.06 microg/g, with a coefficient of variation of 1.7% and a 90-100% lead recovery of a bonemeal standard reference material. Two-thirds of those calcium supplements failed to meet the 1999 California criteria for acceptable lead levels (1.5 microg/daily dose of calcium) in consumer products. The nonchelated synthesized and/or refined calcium products, specifically antacids and infant formulas, had the lowest lead concentrations, ranging from nondetectable to 2.9 microg Pb/g calcium, and had the largest proportion of brands meeting the new criteria (85% of the antacids and 100% of the infant formulas). PMID:10753088

  13. Lead in calcium supplements.

    PubMed Central

    Scelfo, G M; Flegal, A R

    2000-01-01

    Intercalibrated measurements of lead in calcium supplements indicate the importance of rigorous analytical techniques to accurately quantify contaminant exposures in complex matrices. Without such techniques, measurements of lead concentrations in calcium supplements may be either erroneously low, by as much as 50%, or below the detection limit needed for new public health criteria. In this study, we determined the lead content of 136 brands of supplements that were purchased in 1996. The calcium in the products was derived from natural sources (bonemeal, dolomite, or oyster shell) or was synthesized and/or refined (chelated and nonchelated calcium). The dried products were acid digested and analyzed for lead by high resolution-inductively coupled plasma-mass spectrometry. The method's limit of quantitation averaged 0.06 microg/g, with a coefficient of variation of 1.7% and a 90-100% lead recovery of a bonemeal standard reference material. Two-thirds of those calcium supplements failed to meet the 1999 California criteria for acceptable lead levels (1.5 microg/daily dose of calcium) in consumer products. The nonchelated synthesized and/or refined calcium products, specifically antacids and infant formulas, had the lowest lead concentrations, ranging from nondetectable to 2.9 microg Pb/g calcium, and had the largest proportion of brands meeting the new criteria (85% of the antacids and 100% of the infant formulas). Images Figure 1 Figure 2 PMID:10753088

  14. Examples of Dietary Supplement Interactions

    MedlinePlus

    ... the risk of bruising and bleeding. Supplement: Goldenseal Root Possible drug-supplement interaction with: Cyclosporine. Can decrease ... using the liver's cytochrome P450 enzyme system. Goldenseal root may decrease how quickly the liver breaks down ...

  15. An Evidence-Based Review of Fat Modifying Supplemental Weight Loss Products

    PubMed Central

    Egras, Amy M.; Hamilton, William R.; Lenz, Thomas L.; Monaghan, Michael S.

    2011-01-01

    Objective. To review the literature on fat modifying dietary supplements commonly used for weight loss. Methods. Recently published randomized, placebo-controlled trials were identified in PubMed, MEDLINE, International Pharmaceutical Abstracts, Cochrane Database, and Google Scholar using the search terms dietary supplement, herbal, weight loss, obesity, and individual supplement names. Discussion. Data for conjugated linoleic acid (CLA), Garcinia cambogia, chitosan, pyruvate, Irvingia gabonensis, and chia seed for weight loss were identified. CLA, chitosan, pyruvate, and Irvingia gabonensis appeared to be effective in weight loss via fat modifying mechanisms. However, the data on the use of these products is limited. Conclusion. Many obese people use dietary supplements for weight loss. To date, there is little clinical evidence to support their use. More data is necessary to determine the efficacy and safety of these supplements. Healthcare providers should assist patients in weighing the risks and benefits of dietary supplement use for weight loss. PMID:20847896

  16. An evidence-based review of fat modifying supplemental weight loss products.

    PubMed

    Egras, Amy M; Hamilton, William R; Lenz, Thomas L; Monaghan, Michael S

    2011-01-01

    Objective. To review the literature on fat modifying dietary supplements commonly used for weight loss. Methods. Recently published randomized, placebo-controlled trials were identified in PubMed, MEDLINE, International Pharmaceutical Abstracts, Cochrane Database, and Google Scholar using the search terms dietary supplement, herbal, weight loss, obesity, and individual supplement names. Discussion. Data for conjugated linoleic acid (CLA), Garcinia cambogia, chitosan, pyruvate, Irvingia gabonensis, and chia seed for weight loss were identified. CLA, chitosan, pyruvate, and Irvingia gabonensis appeared to be effective in weight loss via fat modifying mechanisms. However, the data on the use of these products is limited. Conclusion. Many obese people use dietary supplements for weight loss. To date, there is little clinical evidence to support their use. More data is necessary to determine the efficacy and safety of these supplements. Healthcare providers should assist patients in weighing the risks and benefits of dietary supplement use for weight loss. PMID:20847896

  17. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  18. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  19. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  20. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  1. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  2. 40 CFR 52.2722 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Puerto Rico § 52.2722 Approval status. With the exceptions set forth in this subpart, the Administrator approves Puerto Rico's plans for...

  3. 40 CFR 52.1772 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Carolina § 52.1772 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves North Carolina's plans...

  4. 40 CFR 52.2172 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) South Dakota § 52.2172 Approval status. With the exceptions set forth in this subpart, the Administrator approves South Dakota's plan as...

  5. 40 CFR 52.1622 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Mexico § 52.1622 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Mexico's plan for...

  6. 40 CFR 52.1622 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Mexico § 52.1622 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Mexico's plan for...

  7. 40 CFR 52.1622 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Mexico § 52.1622 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Mexico's plan for...

  8. 40 CFR 52.1622 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Mexico § 52.1622 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Mexico's plan for...

  9. 40 CFR 52.1622 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Mexico § 52.1622 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Mexico's plan for...

  10. 40 CFR 52.1673 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New York § 52.1673 Approval status. (a) With the exceptions set forth in this section, the Administrator approves the New York State...

  11. 40 CFR 52.1673 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New York § 52.1673 Approval status. (a) With the exceptions set forth in this section, the Administrator approves the New York State...

  12. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  13. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  14. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  15. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  16. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  17. Performance of growing cattle on poor-quality rangelands supplemented with farm-formulated protein supplements in Zimbabwe.

    PubMed

    Gusha, J; Katsande, S; Zvinorova, P I; Halimani, T E; Chiuta, T

    2015-10-01

    Farmers use different non-conventional protein supplements and different feeding strategies to aid their animals survive the dry season in Zimbabwe. The strategies can be giving supplements once a week or once every other day up to very little supplement daily. Supplements are either legume crop residues or forage legumes. However, the efficacy of the use of non-conventional protein supplements in promoting growth and at the same time lowering the age at first calving is little understood. The study tested whether supplementing with farm-formulated non-conventional feeds could reduce live weight loss during the dry season and promote live weight gain as well as early development of sexual maturity in beef cattle. In a completely randomized design, thirty dams with calves on hooves were allocated to five different treatments which were repeated during the dry season for 3 years. The 3-year study results show that weight loss can be controlled, resulting in positive growth in both the pre-weaning and post-weaning phases of growing cattle. Yearlings fed solely on natural pasture lost significant weight during the dry season as compared to supplemented groups. The period to puberty and first calving was achieved at 18 and 27 months, respectively. Using non-conventional protein supplements could thus improve livestock productivity in resource-poor farming communities. It was concluded that smallholder farmers can supplement cattle with a kilogram per day of low-cost farm-based non-conventional legume meal to improve livestock productivity in semi-arid regions of Zimbabwe. PMID:25754582

  18. Approval of High-Risk Medical Devices in the US: Implications for Clinical Cardiology

    PubMed Central

    Rome, Benjamin N.; Kramer, Daniel B.

    2014-01-01

    Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls—most notably related to underperforming ICD leads—have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a “least burdensome” approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in post-market surveillance and comparative effectiveness research remains imperative. PMID:24760423

  19. Herbs, Supplements and Alternative Medicines

    MedlinePlus

    ... not been able to prove that dietary or herbal supplements (including omega-3 supplements, cinnamon, and other herbs) ... of people with diabetes used some type of herbal therapy , while another study found that 31 percent used dietary supplements . Certain ethnic groups, such as Hispanics, Native Americans, ...

  20. Supplemental tooth in primary dentition

    PubMed Central

    Mohan, Ravi Prakash Sasankoti; Verma, Sankalp; Singh, Udita; Agarwal, Neha

    2014-01-01

    An extra tooth causing numerical excess in dentition is described as supernumerary tooth, and the resultant condition is termed as hyperdontia. Hyperdontia is more commonly seen in the permanent dentition than primary one. Supernumerary tooth which resembles tooth shape and supplements for occlusion is called as supplemental tooth. We present a case with supplemental tooth in primary dentition. PMID:24913075

  1. 48 CFR 750.7105 - Approving authorities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS Extraordinary Contractual Actions To Protect Foreign Policy Interests of the United States 750.7105 Approving authorities. All authority to approve...

  2. Vitamin and Mineral Supplement Fact Sheets

    MedlinePlus

    ... Tables Online DRI Tool Daily Value (DV) Tables Vitamin and Mineral Supplement Fact Sheets Search the list ... Supplements: Background Information Botanical Dietary Supplements: Background Information Vitamin and Mineral Fact Sheets Botanical Supplement Fact Sheets ...

  3. 78 FR 19467 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS); DoD Pilot Mentor-Prot g Program AGENCY: Defense Acquisition Regulations System... approved information collection requirement. SUMMARY: In compliance with Section 3506(c)(2)(A) of...

  4. 21 CFR 111.155 - What requirements apply to components of dietary supplements?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... shipment, and of each unique lot within each unique shipment); (2) Quality control personnel review and approve the results of any tests or examinations conducted on components; and (3) Quality...

  5. 30 CFR 250.285 - How do I submit revised and supplemental EPs, DPPs, and DOCDs?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false How do I submit revised and supplemental EPs, DPPs, and DOCDs? 250.285 Section 250.285 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and Information Post-Approval Requirements for the...

  6. 77 FR 48507 - Proposed Information Collection Requests; Federal Student Aid; Foreign School Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    ...The Foreign School Supplemental Application System (FS SAS) is designed as a bridge system that will allow foreign school administrators to enter information directly into the Electronic Application for Approval to Participate in Federal Student Aid Programs (e-App) system in a secure fashion and upload required...

  7. [ERGOGENIC SPORT SUPPLEMENTS FOR ATHLETES].

    PubMed

    Arieli, Rakefet; Lahav, Yair

    2016-06-01

    Use of performance-enhancing supplements occurs at all levels of sports, from recreational athletes to professional athletes. Although some supplements do enhance athletic performance, many have no proven benefits and have adverse effects. Nutritional supplements are categorized into the following categories: I. Apparently Effective. II. Possibly Effective. III. Too Early To Tell. IV. Apparently Ineffective. This article will review 4 ergogenic supplements which are categorized in the first category--"Apparently Effective"--1) Buffer agents 2) Creatine 3) Caffeine and 4 Nitric Oxide. Given the widespread use of performance enhancing supplements, physicians, and dietitians should be prepared to counsel athletes about their effectiveness, safety and legality. PMID:27544991

  8. Effective Nutritional Supplement Combinations

    NASA Astrophysics Data System (ADS)

    Cooke, Matt; Cribb, Paul J.

    Few supplement combinations that are marketed to athletes are supported by scientific evidence of their effectiveness. Quite often, under the rigor of scientific investigation, the patented combination fails to provide any greater benefit than a group given the active (generic) ingredient. The focus of this chapter is supplement combinations and dosing strategies that are effective at promoting an acute physiological response that may improve/enhance exercise performance or influence chronic adaptations desired from training. In recent years, there has been a particular focus on two nutritional ergogenic aids—creatine monohydrate and protein/amino acids—in combination with specific nutrients in an effort to augment or add to their already established independent ergogenic effects. These combinations and others are discussed in this chapter.

  9. Nutrition and nutritional supplementation

    PubMed Central

    Manissier, Patricia

    2009-01-01

    Skin acts as a natural barrier between internal and external environments thus plays an important role in vital biological functions such as protection against mechanical/chemical damages, micro-organisms, ultraviolet damage. Nutrition has a critical impact on strengthening skin’s capabilities to fight against these multiple aggressions. Nutritional deficiencies are often associated with skin health disorders, while diets can either positively or negatively influence skin condition. More recently, the concept of nutritional supplementation has emerged as a new strategy in the daily practice of dermatology as well as a complementary approach to topical cosmetics in the field of beauty. Focusing on human clinical data, this paper proposes to illustrate the link between skin health and nutrition and to exemplify the beneficial actions of nutritional supplementation in skin health and beauty. PMID:20808515

  10. Drugs Approved for Wilms Tumor

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and other childhood kidney cancers. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  11. Drugs Approved for Liver Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for liver cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  12. Drugs Approved for Esophageal Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for esophageal cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  13. Drugs Approved for Vulvar Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for vulvar cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  14. Drugs Approved for Endometrial Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for endometrial cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  15. Drugs Approved for Bone Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bone cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  16. Drugs Approved for Penile Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for penile cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  17. FDA-Approved HIV Medicines

    MedlinePlus

    ... and acronyms) Brand Name FDA Approval Date Nucleoside Reverse Transcriptase Inhibitors (NRTIs) NRTIs block reverse transcriptase, an enzyme HIV ... AZT, ZDV) Retrovir March 19, 1987 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) NNRTIs bind to and later alter reverse ...

  18. Drugs Approved for Pancreatic Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for pancreatic cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  19. Drugs Approved for Skin Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  20. Drugs Approved for Vaginal Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) to prevent vaginal cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  1. Drugs Approved for Breast Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for breast cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  2. Drugs Approved for Malignant Mesothelioma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for malignant mesothelioma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  3. Drugs Approved for Lung Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for lung cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  4. Drugs Approved for Bladder Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bladder cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  5. Drugs Approved for Kaposi Sarcoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Kaposi sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  6. Gaining approval for clinical research.

    PubMed

    Cobb, Vanessa; Srinivasan, Neil; Lambiase, Pier

    2016-07-01

    Set-up and delivery of a clinical research project can be complicated and difficult. This article introduces the regulatory processes involved in gaining approval for clinical research and discusses the obstacles that may be encountered. PMID:27388381

  7. Evaluation of the antihyperlipidemic properties of dietary supplements.

    PubMed

    Caron, M F; White, C M

    2001-04-01

    We reviewed the published literature regarding the antihyperlipidemic effects of dietary supplements. A search of MEDLINE database, EMBASE Drugs and Pharmacology database, and the Internet was performed, and pertinent studies were identified and evaluated. References from published articles and tertiary references were used to gather additional data. Published trials indicate that red yeast rice, tocotrienols, gugulipid, garlic, and soy protein all have antihypercholesterolemic effects. These supplements, as well as omega-3 fatty acids, also have antihypertriglyceridemic effects. In clinical trials none of the agents led to a reduction in low-density lipoproteins greater than 25%, suggesting modest efficacy. When recommending these supplements, clinicians should keep in mind that their long-term safety is not established and patients should be monitored closely. PMID:11310521

  8. The challenges of iodine supplementation: a public health programme perspective.

    PubMed

    Untoro, Juliawati; Timmer, Arnold; Schultink, Werner

    2010-02-01

    An adequate iodine intake during pregnancy, lactation and early childhood is particularly critical for optimal brain development of the foetus and of children 7-24 months of age. While the primary strategy for sustainable elimination of iodine deficiency remains universal salt iodisation, the World Health Organization and the United Nations Children's Fund recommend a complementary strategy of iodine supplements as a temporary measure when salt iodisation could not be implemented. This article aims to review current evidence on efficacy and implications of implementing iodine supplementation as a public health measure to address iodine deficiency. Iodine supplementation seems unlikely to reach high coverage in a rapid, equitable and sustained way. Implementing the programme requires political commitment, effective and efficient supply, distribution and targeting, continuous education and communication and a robust monitoring system. Thus, universal salt iodisation should remain the primary strategy to eliminate iodine deficiency. PMID:20172473

  9. Flavonoids, the emerging dietary supplement against cisplatin-induced nephrotoxicity.

    PubMed

    Athira, K V; Madhana, Rajaram Mohanrao; Lahkar, Mangala

    2016-03-25

    The letter illustrates the emerging potential of flavonoids as dietary supplement to ameliorate cisplatin-induced nephrotoxicity and refers to the recent article on ''Anti-apoptotic and anti-inflammatory effects of naringin on cisplatin-induced renal injury in the rat'' by Chtourou et al. They demonstrated that supplementation of naringin, a flavanone glycoside, found in grape and citrus fruit species, can attenuate cisplatin-induced renal dysfunction via restoration of redox balance and suppression of inflammation, NF-κB activation and apoptosis. The chemotherapeutic efficacy of cisplatin has always compelled the researchers to find solution to ameliorate its side effects. In recent years, numerous candidates have been evaluated for their protective potential against cisplatin-induced nephrotoxicity and flavonoids have come up with promising results. The future prospects might be promising with a proper refinement and collective integration of the preclinical and clinical research in the field of flavonoid supplementation to cisplatin therapy. PMID:26876905

  10. Vitamin supplementation and megadoses.

    PubMed

    Blair, K A

    1986-07-01

    Almost one-third of American adults regularly take vitamins and supplements. If taken incorrectly or in excess, these vitamins may be a potential health hazard. Vitamins are essential nutrients which, in combination with other nutrients (e.g., fats, carbohydrates and proteins), foster normal metabolism. Vitamins also interact with each other. For example, vitamin C participates in the metabolism of folic acid, and vitamin E facilitates the absorption and storage of vitamin A. Because the biological functions of vitamins are interrelated, a diet poor in vitamins, carbohydrates, fats and proteins is not necessarily enhanced by vitamin supplementation. When vitamins are taken in excess of the Recommended Dietary Allowances or the individual's needs, the vitamins no longer function as vitamins but instead act as drugs, with such pharmacological effects as clinical toxicities and the abnormal utilization of vitamins. There are six categories that require vitamin supplements and, in some cases, megadoses. These will be discussed in detail. In addition, a brief table showing the Recommended Dietary Allowances will be given which the nurse practitioner can use in assessing nutritional needs of the client so that necessary adjustments can be made. Finally, a brief review of the potential risks and benefits of megadoses in normal, healthy adults will be given. PMID:3737019

  11. Nutritional Supplements for the Treatment of Attention-Deficit Hyperactivity Disorder

    PubMed Central

    Bloch, Michael H.; Mulqueen, Jilian

    2014-01-01

    Synopsis Polyunsaturated fatty acid supplementation has demonstrated evidence of efficacy in meta-analysis of randomized, placebo-controlled trials in ADHD. The benefits of polyunsaturated fatty acid appear small compared to the effect sizes observed for traditional pharmacological treatments of ADHD. Some evidence suggests that polyunsaturated fatty acid formulations with higher eicosapentaenoic acid may be more effective in improving ADHD symptoms. Melatonin appears to be effective in treating chronic insomnia in children with ADHD but appears to have minimal effects in reducing core ADHD symptoms. Iron and zinc supplementation may have benefit in reducing ADHD symptoms in children with or at high risk of deficiency. Data demonstrating efficacy of iron, zinc or magnesium in non-nutrient deficient ADHD populations is lacking. Many other natural supplements are widely utilized in the United States despite minimal evidence of efficacy and possible side-effects. PMID:25220092

  12. A review of creatine supplementation in age-related diseases: more than a supplement for athletes.

    PubMed

    Smith, Rachel N; Agharkar, Amruta S; Gonzales, Eric B

    2014-01-01

    Creatine is an endogenous compound synthesized from arginine, glycine and methionine. This dietary supplement can be acquired from food sources such as meat and fish, along with athlete supplement powders. Since the majority of creatine is stored in skeletal muscle, dietary creatine supplementation has traditionally been important for athletes and bodybuilders to increase the power, strength, and mass of the skeletal muscle. However, new uses for creatine have emerged suggesting that it may be important in preventing or delaying the onset of neurodegenerative diseases associated with aging. On average, 30% of muscle mass is lost by age 80, while muscular weakness remains a vital cause for loss of independence in the elderly population. In light of these new roles of creatine, the dietary supplement's usage has been studied to determine its efficacy in treating congestive heart failure, gyrate atrophy, insulin insensitivity, cancer, and high cholesterol. In relation to the brain, creatine has been shown to have antioxidant properties, reduce mental fatigue, protect the brain from neurotoxicity, and improve facets/components of neurological disorders like depression and bipolar disorder. The combination of these benefits has made creatine a leading candidate in the fight against age-related diseases, such as Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis, long-term memory impairments associated with the progression of Alzheimer's disease, and stroke. In this review, we explore the normal mechanisms by which creatine is produced and its necessary physiology, while paying special attention to the importance of creatine supplementation in improving diseases and disorders associated with brain aging and outlining the clinical trials involving creatine to treat these diseases. PMID:25664170

  13. Development of drug-approval regulations for medical countermeasures against CBRN agents in Japan.

    PubMed

    Shimazawa, Rumiko; Ikeda, Masayuki

    2015-01-01

    To develop approval regulations for drugs against chemical, biological, radiological, or nuclear (CBRN) agents in Japan, and to help inform arguments about the development of anti-CBRN agents, we analyzed documentation describing approval processes and data for drugs against CBRN agents. Sixteen countermeasure products against 10 CBRN agents have been approved in Japan. Approval schemes were grouped into 3 categories: application for off-label uses, expedited review for antiterrorism measures, and expedited review. Ten drug applications were designated "priority reviews," and the median review time was 4.4 months. No application relied exclusively on clinical trials to expose patients to CBRN threats. Clinical experience with drugs in victims of unexpected exposure was not necessarily important for approval. The United States is the most advanced country in terms of developing medical countermeasure products against CBRN agents. Japan has similarities with the US in approved products and application packages, but there were 3 unapproved products or indications that were approved under the Animal Rule in the US. The Animal Rule might encourage development of a novel product by providing efficacy evaluation in animal studies. The US also has regulations that do not exist in Japan that authorize administration of an investigational drug outside a clinical trial for patients. Introduction of the Animal Rule and expanded access of investigational drugs could contribute to development and approvals of novel countermeasure products and improve an emergency response in a crisis in Japan. PMID:25813978

  14. 9 CFR 147.52 - Approved tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In...

  15. 28 CFR 2.41 - Travel approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Travel approval. 2.41 Section 2.41..., YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2.41 Travel approval. (a) The probation officer may approve travel outside the district without approval of...

  16. 30 CFR 7.49 - Approval marking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box....

  17. 30 CFR 7.49 - Approval marking.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box....

  18. 38 CFR 21.292 - Course approvals.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only... rehabilitation services under Chapter 31. (Authority: 38 U.S.C. 3106) (b) General. VA staff in consultation with... approved by one of the agencies identified in paragraph (c) of this section, VR&E staff shall...

  19. 40 CFR 123.61 - Approval process.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 22 2011-07-01 2011-07-01 false Approval process. 123.61 Section 123... REQUIREMENTS Program Approval, Revision, and Withdrawal § 123.61 Approval process. (a) After determining that a... § 123.21 the Administrator shall approve or disapprove the program based on the requirements of...

  20. Implications of Recent Drug Approvals for Older Adults

    PubMed Central

    Eisenhower, Christine; Koronkowski, Michael; Marcum, Zachary

    2016-01-01

    More than 100 medications were approved by the US Food and Drug Administration as new drugs or for new indications in 2014 and 2015. Several of the new drugs may benefit older adults, but adverse events and pharmacokinetic changes due to aging must be considered. This article will focus on three recently approved drugs that are marketed for chronic conditions that can affect older adults: suvorexant, for treatment of insomnia; edoxaban, for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for treatment of venous thromboembolism; and droxidopa, for treatment of symptomatic neurogenic orthostatic hypotension. Information about indications, mechanisms of action, dosing, efficacy, and safety are reviewed. The place of each agent in therapy for older adults is also discussed. PMID:27340374

  1. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 6 2011-10-01 2011-10-01 false Action by approval authority-approval by design type. 451.13 Section 451.13 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers §...

  2. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 6 2011-10-01 2011-10-01 false Action by approval authority-individual approval. 451.16 Section 451.16 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers §...

  3. Supplementing National Menu Labeling

    PubMed Central

    White, Lexi C.

    2012-01-01

    The US Food and Drug Administration’s forthcoming national menu labeling regulations are designed to help curb the national obesity epidemic by requiring calorie counts on restaurants’ menus. However, posted calories can be easily ignored or misunderstood by consumers and fail to accurately describe the healthiness of foods. We propose supplemental models that include nutritional information (e.g., fat, salt, sugar) or specific guidance (e.g., “heart-healthy” graphics). The goal is to empower restaurant patrons with better data to make healthier choices, and ultimately to reduce obesity prevalence. PMID:23078494

  4. Special Supplement Introduction: Hallucinations

    PubMed Central

    Fernyhough, Charles; Waters, Flavie

    2014-01-01

    This Special Supplement presents reports from 11 working groups of the interdisciplinary International Consortium on Hallucination Research meeting in Durham, UK, September 2013. Topics include psychological therapies for auditory hallucinations, culture and hallucinations, hallucinations in children and adolescents, visual hallucinations, interdisciplinary approaches to the phenomenology of auditory verbal hallucinations (AVHs), AVHs in persons without need for care, a multisite study of the PSYRATS instrument, subtypes of AVHs, the Hearing Voices Movement, Research Domain Criteria for hallucinations, and cortical specialization as a route to understanding hallucinations. PMID:24936079

  5. Supplementing national menu labeling.

    PubMed

    Hodge, James G; White, Lexi C

    2012-12-01

    The US Food and Drug Administration's forthcoming national menu labeling regulations are designed to help curb the national obesity epidemic by requiring calorie counts on restaurants' menus. However, posted calories can be easily ignored or misunderstood by consumers and fail to accurately describe the healthiness of foods. We propose supplemental models that include nutritional information (e.g., fat, salt, sugar) or specific guidance (e.g., "heart-healthy" graphics). The goal is to empower restaurant patrons with better data to make healthier choices, and ultimately to reduce obesity prevalence. PMID:23078494

  6. Nutrient supplementation: improving male fertility fourfold.

    PubMed

    Mora-Esteves, Cesar; Shin, David

    2013-07-01

    Oxidative stress can contribute to impairment in spermatogenesis leading to male-factor infertility. The effectiveness of various antioxidants (such as carnitine, vitamin C, vitamin E, selenium, carotenoids, glutathione, N-acetylcysteine, zinc, folic acid, and coenzyme Q10) is variable with respect to improving semen parameters and pregnancy rates. A recent Cochrane review determined that men taking antioxidants had a statistically significant increase in both live birth rates and pregnancy rates. For those undergoing assisted reproduction, the odds ratio that antioxidant use would improve pregnancy rates was 4.18, with a 4.85-fold improvement in live birth rate also noted. Further investigation with randomized, controlled clinical trials is needed to confirm the safety and efficacy of antioxidant supplementation in the medical management and treatment of male infertility. PMID:23775385

  7. Bodybuilding supplementation and tooth decay.

    PubMed

    Ali, M S; Batley, H; Ahmed, F

    2015-07-10

    Supplementation is a key component in bodybuilding and is increasingly being used by amateur weight lifters and enthusiasts to build their ideal bodies. Bodybuilding supplements are advertised to provide nutrients needed to help optimise muscle building but they can contain high amounts of sugar. Supplement users are consuming these products, while not being aware of their high sugar content, putting them at a higher risk of developing dental caries. It is important for dental professionals to recognise the increased risk for supplement users and to raise awareness, provide appropriate preventative advice and be knowledgeable of alternative products to help bodybuilders reach their goals, without increasing the risk of dental caries. PMID:26159983

  8. Nutritional Supplementation and Meal Timing

    NASA Astrophysics Data System (ADS)

    Farris, Jim

    For the competitive athlete and the serious recreational athlete, nutritional supplementation can have a positive effect on training and on performance. There are many fad supplements on the market, and many that have come and gone. However, two nutrients have withstood the test of time and many tests in research laboratories around the world, and they continue to have positive training- and performance-enhancing effects. Carbohydrates are commonly supplemented to improve energy availability and to replace valuable muscle and liver glycogen stores. Protein supplementation usually is associated with building muscle tissue.

  9. Too little, too late: ineffective regulation of dietary supplements in the United States.

    PubMed

    Starr, Ranjani R

    2015-03-01

    Millions of people in the United States consume dietary supplements hoping to maintain or improve their health; however, extensive research has failed to demonstrate the efficacy of numerous supplements in disease prevention. In addition, concerns about the safety of routine and high-dose supplementation have been raised. The Food and Drug Administration regulates dietary supplement quality, safety, and labeling, and the Federal Trade Commission monitors advertisements and marketing; still, vast enforcement challenges remain, and optimal governmental oversight has not been achieved. If the composition and quality of ingredients cannot be reliably ensured, the validity of research on dietary supplements is questionable. Moreover, the health of the US public is put at risk. PMID:25602879

  10. Supplemental fuel vapor system

    SciTech Connect

    Foster, P.M.

    1991-01-08

    This patent describes a supplemental fuel system utilizing fuel vapor. It comprises: an internal combustion engine including a carburetor and an intake manifold; a fuel tank provided with air vents; a fuel conduit having a first end connected to the fuel tank and in communication with liquid fuel in the tank and a second end connected to the carburetor; the fuel conduit delivering the liquid fuel to the carburetor from the fuel tank; a fuel vapor conduit having a first end connected to the fuel tank at a location displaced from contact with the liquid fuel and a second end connected to a carbon canister; a PCV conduit having a first end connected to a pollution control valve and a second end connected to the intake manifold; and, an intermediate fuel vapor conduit having a first end connected to the fuel vapor conduit and a second end connected to the PCV conduit; wherein the air vents continuously provide air to the tank to mix with the liquid fuel and form fuel vapor. The fuel vapor drawn from the fuel tank by vacuum developed in the intake manifold and flows through the fuel vapor conduit. The intermediate fuel vapor conduit and the intake manifold to combustion chambers of the internal combustion engine so as to supplement fuel delivered to the engine by the fuel conduit. The liquid fuel and the fuel vapor constantly delivered to the engine during normal operation.

  11. Androgen supplementation during aging: development of a physiologically appropriate protocol.

    PubMed

    Urbanski, Henryk F; Sorwell, Krystina G; Garyfallou, Vasilios T; Garten, Jamie; Weiss, Alison; Renner, Laurie; Neuringer, Martha; Kohama, Steven G

    2014-04-01

    Men show an age-related decline in the circulating levels of testosterone (T) and dehydroepiandrosterone sulfate (DHEAS). Consequently, there is interest in developing androgen supplementation paradigms for old men that replicate the hormone profiles of young adults. In the present study, we used old (21-26 years old) male rhesus monkeys as a model to examine the efficacy of an androgen supplementation paradigm that comprised oral T administration (12 mg/kg body weight, dissolved in sesame oil/chocolate) in the evening, and two oral DHEA administrations, 3 hr apart (0.04 mg/kg body weight, dissolved in sesame oil/chocolate) in the morning. After 5 days of repeated hormone supplementation, serial blood samples were remotely collected from each animal hourly across the 24-hr day, and assayed for cortisol, DHEAS, T, 5α-dihydrotestosterone (DHT), estrone (E1), and 17β-estradiol (E2). Following androgen supplementation, T levels were significantly elevated and this was associated with a more sustained nocturnal elevation of T's primary bioactive metabolites, DHT and E1 and E2. Plasma DHEAS levels were also significantly elevated after androgen supplementation; DHEAS levels rose in the early morning and gradually declined during the course of the day, closely mimicking the profiles observed in young adults (7-12 years old); in contrast, cortisol levels were unaltered by the supplementation. Together the data demonstrate a non-invasive androgen supplementation paradigm that restores youthful circulating androgen levels in old male primates. Because this paradigm preserves the natural circulating circadian hormone patterns, we predict that it will produce fewer adverse side effects, such as perturbed sleep or cognitive impairment. PMID:24134213

  12. 77 FR 31295 - Notice of Intent To Request Revision and Extension of a Currently Approved Information Collection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-25

    ... renewal of approval for an annual information collection on supplemental food security questions in the... monitor household-level food security and food insecurity in the United States; to assess food security and changes in food security for population subgroups; to assess the need for, and performance...

  13. 77 FR 24451 - Direct Final Approval of Hospital/Medical/Infectious Waste Incinerators State Plan for Designated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-24

    ...EPA is proposing to approve, through direct final rulemaking, Illinois' revised State Plan to control air pollutants from Hazardous/ Medical/Infectious Waste Incinerators (HMIWI). The Illinois Environmental Protection Agency submitted the revised State Plan on November 8, 2011 and supplemented it on December 28, 2011, following the required public process. The revised State Plan is consistent......

  14. 78 FR 66826 - Prior Label Approval System: Generic Label Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... the Agency (76 FR 75809). FSIS also proposed to combine the regulations that provide for the approval... preamble (76 FR 75814), FSIS wrote: . . . statements on labels that are defined in FSIS's regulations or... ``Product Labeling: Definition of the Term ``Natural'' and related materials (71 FR 70503, Dec. 5, 2006)...

  15. Whole Food versus Supplement: Comparing the Clinical Evidence of Tomato Intake and Lycopene Supplementation on Cardiovascular Risk Factors12

    PubMed Central

    Burton-Freeman, Britt M.; Sesso, Howard D.

    2014-01-01

    Cardiovascular disease (CVD) is a major contributor to morbidity and mortality in the United States and worldwide. A link between diet and CVD is well established, with dietary modification a foundational component of CVD prevention and management. With the discovery of bioactive components beyond the essential nutrients of foods, a new era of nutritional, medical, botanical, physiologic, and analytical sciences has unfolded. The ability to identify, isolate, purify, and deliver single components has expanded the dietary supplement business and health opportunity for consumers. Lycopene is an example of a food component that has attracted attention from scientists as well as food, agriculture, and dietary supplement industries. A major question, however, is whether delivering lycopene through a supplement source is as effective as or more effective than consuming lycopene through whole food sources, specifically the tomato, which is the richest source of lycopene in the Western diet. In this review, we examined clinical trials comparing the efficacy of lycopene supplements with tomato products on intermediate CVD risk factors including oxidative stress, inflammation, endothelial function, blood pressure, and lipid metabolism. Overall, the present review highlights the need for more targeted research; however, at present, the available clinical research supports consuming tomato-based foods as a first-line approach to cardiovascular health. With the exception of blood pressure management where lycopene supplementation was favored, tomato intake provided more favorable results on cardiovascular risk endpoints than did lycopene supplementation. Indeed, future research that is well designed, clinically focused, mechanistically revealing, and relevant to human intake will undoubtedly add to the growing body of knowledge unveiling the promise of tomatoes and/or lycopene supplementation as an integral component of a heart-healthy diet. PMID:25469376

  16. A review of creatine supplementation in age-related diseases: more than a supplement for athletes

    PubMed Central

    Smith, Rachel N.; Agharkar, Amruta S.; Gonzales, Eric B.

    2014-01-01

    Creatine is an endogenous compound synthesized from arginine, glycine and methionine. This dietary supplement can be acquired from food sources such as meat and fish, along with athlete supplement powders. Since the majority of creatine is stored in skeletal muscle, dietary creatine supplementation has traditionally been important for athletes and bodybuilders to increase the power, strength, and mass of the skeletal muscle. However, new uses for creatine have emerged suggesting that it may be important in preventing or delaying the onset of neurodegenerative diseases associated with aging. On average, 30% of muscle mass is lost by age 80, while muscular weakness remains a vital cause for loss of independence in the elderly population. In light of these new roles of creatine, the dietary supplement’s usage has been studied to determine its efficacy in treating congestive heart failure, gyrate atrophy, insulin insensitivity, cancer, and high cholesterol. In relation to the brain, creatine has been shown to have antioxidant properties, reduce mental fatigue, protect the brain from neurotoxicity, and improve facets/components of neurological disorders like depression and bipolar disorder. The combination of these benefits has made creatine a leading candidate in the fight against age-related diseases, such as Parkinson’s disease, Huntington’s disease, amyotrophic lateral sclerosis, long-term memory impairments associated with the progression of Alzheimer’s disease, and stroke. In this review, we explore the normal mechanisms by which creatine is produced and its necessary physiology, while paying special attention to the importance of creatine supplementation in improving diseases and disorders associated with brain aging and outlining the clinical trials involving creatine to treat these diseases. PMID:25664170

  17. Performance enhancement with supplements: incongruence between rationale and practice

    PubMed Central

    Petróczi, Andrea; Naughton, Declan P; Mazanov, Jason; Holloway, Allison; Bingham, Jerry

    2007-01-01

    Background Athletes are expected to consider multiple factors when making informed decision about nutritional supplement use. Besides rules, regulations and potential health hazards, the efficacy of different nutritional supplements in performance enhancement is a key issue. The aim of this paper was to find evidence for informed decision making by investigating the relationship between specific performance-related reasons for supplement use and the reported use of nutritional supplements. Methods The 'UK Sport 2005 Drug Free Survey' data (n = 874) were re-analysed using association [χ2] and 'strength of association' tests [ϕ] to show the proportion of informed choices and to unveil incongruencies between self-reported supplement use and the underlying motives. Results Participants (n = 520) reported supplement use in the pattern of: vitamin C (70.4%), creatine (36.1%), whey protein (30.6%), iron (29.8%), caffeine (23.8%), and ginseng (8.3%) for the following reasons: strength maintenance (38.1%), doctors' advice (24.2%), enhancing endurance (20.0%), ability to train longer (13.3%), and provided by the governing body (3.8%). Of thirty possible associations between the above supplements and reasons, 11 were predictable from literature precedents and only 8 were evidenced and these were not strong (ϕ < .7). The best associations were for the ability to train longer with creatine (reported by 73.9%, χ2 = 49.14, p < .001; ϕ = .307, p < .001), and maintaining strength with creatine (reported by 62.6%, χ2 = 97.08, p < .001; ϕ = .432, p < .001) and whey protein (reported by 56.1%, χ2 = 97.82, p < .001; ϕ = .434, p < .001). Conclusion This study provided a platform for assessing congruence between athletes' reasons for supplement use and their actual use. These results suggest that a lack of understanding exists in supplement use. There is an urgent need to provide accurate information which will help athletes make informed choices about the use of supplements

  18. Effect of taking dietary supplement on hematological and biochemical parameters in male bodybuilders an equation model

    PubMed Central

    Meamar, Rokhsareh; Maracy, Mohammad; Nematollahi, Shahrzad; Yeroshalmi, Shemouil; Zamani-Moghaddam, Ali; Ghazvini, Mohammad Reza Aghaye

    2015-01-01

    Background: The improved physical action following administration of supplements to bodybuilders was supported by changes in laboratory parameters. Despite the fact that these supplements are sometimes associated both advantage and side effects, this study were conducted for the purpose of evaluating the possible effects of some commonly used supplements in bodybuilders on the hematological and biochemical parameters. Materials and Methods: In this study, we included 40 male bodybuilders as cases and 40 controls in the age group of 20-40 years. They used different kinds of supplements for 1 year. In general, all the supplements used were classified into two groups: hormonal and non-hormonal. Laboratory tests were requested for evaluation of hematological and biochemical parameters. Results: In an equation model, we found that weight (P = 0.024), duration of bodybuilding (P < 0.001), and duration of hormone supplement consumption (P < 0.001) were loaded significantly on the latent variables, demographic and dietary supplement, respectively. The relationship between dietary supplement and biochemical and hematological parameters was significant (P = 0.01) and some of these parameters including creatinine (P = 0.023), blood aspartate aminotransferase (AST) (P < 0.001), alanine aminotransferase (ALT) (P < 0.001), and red blood cell distribution (RDW) (P = 0.046) had a significant role than others. In a multivariate regression model, we found that WBC (P < 0.001), platelets (P < 0.001), blood urea nitrogen (BUN; P < 0.001), creatinine (P < 0.001), AST (P = 0.005), and ALT (P = 0.001) were higher in athletes than in controls. Conclusions: It is strongly advised that there should be some concerns about possible supplement-induced changes in the laboratory exams for bodybuilders. The available supplements are unchecked and not approved by the US Food and Drug Administration (FDA). More studies should be designed for a better and precise administration of each supplement in

  19. Efficacy, safety, and patient acceptability of the Essure™ procedure

    PubMed Central

    Lessard, Collette R; Hopkins, Matthew R

    2011-01-01

    The Essure™ system for permanent contraception was developed as a less invasive method of female sterilization. Placement of the Essure™ coil involves a hysteroscopic transcervical technique. This procedure can be done in a variety of settings and with a range of anesthetic options. More than eight years have passed since the US Food and Drug Administration approval of Essure™. Much research has been done to evaluate placement success, adverse outcomes, satisfaction, pain, and the contraceptive efficacy of the Essure™. The purpose of this review is to summarize the available literature regarding the efficacy, safety, and patient satisfaction with this new sterilization technique. PMID:21573052

  20. Rosuvastatin safety: lessons from the FDA review and post-approval surveillance.

    PubMed

    Davidson, Michael H

    2004-11-01

    Rosuvastatin is the first statin approved by the regulatory authorities since the withdrawal of cerivastatin. Although highly efficacious, this new statin has generated considerable controversy regarding its safety. Rosuvastatin was approved for clinical use based on the largest pre-approval database for all statins prior to commercial use. In this database, rosuvastatin had a similar safety profile to other approved statins up to the highest approval dose of 40 mg. As with all statins, there is a marked increase in adverse effects when the dose is titrated from 40 to 80 mg, and rosuvastatin demonstrates a similar dose/toxicity relationship. In the pre-approval data trials on 80 mg, there was a 1.0% (n = 16) incidence of myopathy and 7 patients developed rhabdomyolysis. However the approval. PMID:15500414

  1. Should You Take Dietary Supplements?

    MedlinePlus

    ... study. These include glucosamine (for joint pain) and herbal supplements such as echinacea (immune health) and flaxseed oil ( ... be fine,” Coates says. “According to the FDA, supplement products most likely ... ingredients are herbal remedies promoted for weight loss and for sexual ...

  2. Dietary Supplements: What Is Safe?

    MedlinePlus

    ... escape to close saved articles window. My Saved Articles » My ACS » Dietary Supplements: What Is Safe? Download Printable Version [PDF] » Dietary supplements include things like vitamins, minerals, herbs, or products made from plants, animal parts, algae, seafood, or yeasts. The information here can ...

  3. Drugs Approved for Testicular Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for testicular cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  4. Drugs Approved for Cervical Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for cervical cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  5. New Evaluation System Wins Approval

    ERIC Educational Resources Information Center

    Barrett, Laura

    2011-01-01

    All Massachusetts school districts will have to adopt new evaluation systems based on a state framework that was approved by the Board of Elementary and Secondary Education on June 28. The new system will be phased in over three years, beginning with Level 4 schools--those designated "underperforming" by the state--in the 2011-12 school year.…

  6. Drugs Approved for Hodgkin Lymphoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Hodgkin lymphoma. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  7. Drugs Approved for Myeloproliferative Neoplasms

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for myeloproliferative neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  8. Drugs Approved for Multiple Myeloma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for multiple myeloma and other plasma cell neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  9. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

    PubMed Central

    Hatswell, Anthony J; Baio, Gianluca; Berlin, Jesse A; Irs, Alar; Freemantle, Nick

    2016-01-01

    Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. Objective To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods Drug approval data were downloaded from the EMA website and the ‘Drugs@FDA’ database for all decisions on pharmaceuticals published from 1 January 1999 to 8 May 2014. The details of eligible applications were extracted, including the therapeutic area, type of approval and review period. Results Over the period of the study, 76 unique indications were granted without RCT results (44 by the EMA and 60 by the FDA), demonstrating that a substantial number of treatments reach the market without undergoing an RCT. The majority was for haematological malignancies (34), with the next most common areas being oncology (15) and metabolic conditions (15). Of the applications made to both agencies with a comparable data package, the FDA granted more approvals (43/44 vs 35/44) and took less time to review products (8.7 vs 15.5 months). Products reached the market first in the USA in 30 of 34 cases (mean 13.1 months) due to companies making FDA submission before EMA submissions and faster FDA review time. Discussion Despite the frequency with which approvals are granted without RCT results, there is no systematic monitoring of such treatments to confirm their effectiveness or consistency regarding when this form of evidence is appropriate. We recommend a more open debate on the role of marketing authorisations granted without RCT results, and the development of guidelines on what constitutes an acceptable data package for regulators. PMID:27363818

  10. Nutritional Supplements for Endurance Athletes

    NASA Astrophysics Data System (ADS)

    Rasmussen, Christopher J.

    Athletes engaged in heavy endurance training often seek additional nutritional strategies to help maximize performance. Specific nutritional supplements exist to combat certain factors that limit performance beginning with a sound everyday diet. Research has further demonstrated that safe, effective, legal supplements are in fact available for today's endurance athletes. Several of these supplements are marketed not only to aid performance but also to combat the immunosuppressive effects of intense endurance training. It is imperative for each athlete to research the legality of certain supplements for their specific sport or event. Once the legality has been established, it is often up to each individual athlete to decipher the ethics involved with ingesting nutritional supplements with the sole intent of improving performance.

  11. Approval of Raxibacumab for the Treatment of Inhalation Anthrax Under the US Food and Drug Administration “Animal Rule”

    PubMed Central

    Tsai, Chia-Wei; Morris, Stephen

    2015-01-01

    On December 14, 2012, the FDA approved Raxibacumab, the first monoclonal antibody product developed under Project BioShield to achieve this milestone, and the first biologic product to be approved through the FDA animal efficacy rule (or “Animal Rule”). Raxibacumab is approved for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibiotic drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or not appropriate. The developmental process required for approval of Raxibacumab illustrates many of the challenges that product developers may encounter when pursuing approval under the Animal Rule and highlights a number of important regulatory and policy issues. PMID:26648915

  12. Military-specific application of nutritional supplements: a brief overview

    PubMed Central

    Hoedebecke, Kyle; Brink, Will

    2015-01-01

    The Soldiers of America's military endure numerous physical and mental challenges that demand strict physical fitness regimens, extreme mental agility, and a perpetual readiness to deploy at a moment's notice. The chronicity of these stressors has the potential to dramatically reduce performance - both directly and indirectly.  Because of this risk, many Soldiers turn to nutritional supplements with hopes of optimizing performance. Increasing amounts of research have demonstrated that various supplements may enhance overall physical prowess, health, and offer quicker recovery in the face of corporal or psychological extremes. Most individuals, including many medical and nutrition professionals, possess only an elementary comprehension of nutritional supplements and their effect on Soldiers in training or combat environments. Nevertheless, a grasp of these details is required for safety and optimal benefits. Various compounds have been evaluated - to include evidence within the military setting - and found to augment endurance, increase cognitive function, decrease knee pain, or offer hearing or lung protection in the face of high-energy impulses. These efficacious outcomes may serve to augment the health and longevity of these Soldiers; however, continued research is needed for efficacy and long-term safety within specific environments. PMID:25949806

  13. A new quat demonstrates high biocidal efficacy with low foam

    SciTech Connect

    Murray, D.T.

    1997-12-01

    Decylisononyldimethylammonium chloride (DIDMAC) has been recently developed, patented and received EPA approval for use in cooling water systems. This product overcomes the high foaming traits of traditional quats, while still providing highly efficacious microbiological and mollusc fouling control. In addition to excellent algicidal and mollusc control, this product has shown a synergistic relationship when used in concert with methylisothiazolone (MIT) chemistry in both laboratory and field evaluations.

  14. Currently approved and emerging oral therapies in multiple sclerosis: An update for the ophthalmologist.

    PubMed

    Eckstein, Christopher; Bhatti, M Tariq

    2016-01-01

    Although our understanding of multiple sclerosis (MS) has grown substantially, its cause remains unknown. Nonetheless, in the past 3 decades, there have been tremendous advancements in the development of disease-modifying drugs (DMDs). In July 1993, the United States Food and Drug Administration approved the first disease-modifying drug-interferon β- and there are currently 13 medications approved for use in relapsing MS. All the early medications are administered either as a subcutaneous or intramuscular injection, and despite the clinical efficacy and safety of these medications, many patients were hampered by the inconvenience of injections and injection-related side effects. In September 2010, the first oral DMD-fingolimod-was approved. Since then, 2 additional oral DMDs (teriflunomide and dimethyl fumarate) have been approved, and several other oral medications are being evaluated in extensive MS development programs. Because of frequent ocular involvement, ophthalmologists are often involved in the care of MS patients and therefore need to be aware of the current treatment regimens prescribed by neurologists, some of which can have significant ophthalmic adverse events. We update the current advancements in the treatment of MS and discuss the published clinical data on the efficacy and safety of the currently approved and emerging oral therapies in MS. PMID:26703886

  15. Drugs Approved for Soft Tissue Sarcoma

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Soft Tissue Sarcoma This page lists ... soft tissue sarcoma that are not listed here. Drugs Approved for Soft Tissue Sarcoma Cosmegen (Dactinomycin) Dactinomycin ...

  16. Drugs Approved for Head and Neck Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Head and Neck Cancer This page ... and neck cancer that are not listed here. Drugs Approved for Head and Neck Cancer Abitrexate (Methotrexate) ...

  17. Drugs Approved for Stomach (Gastric) Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Stomach (Gastric) Cancer This page lists ... stomach (gastric) cancer that are not listed here. Drugs Approved for Stomach (Gastric) Cancer Cyramza (Ramucirumab) Docetaxel ...

  18. Drugs Approved for Colon and Rectal Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Colon and Rectal Cancer This page ... and rectal cancer that are not listed here. Drugs Approved for Colon Cancer Avastin (Bevacizumab) Bevacizumab Camptosar ( ...

  19. Drugs Approved for Non-Hodgkin Lymphoma

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Non-Hodgkin Lymphoma This page lists ... non-Hodgkin lymphoma that are not listed here. Drugs Approved for Non-Hodgkin Lymphoma Abitrexate (Methotrexate) Adcetris ( ...

  20. FDA Approves New Weight-Loss Device

    MedlinePlus

    ... gov/news/fullstory_159362.html FDA Approves New Weight-Loss Device Surgically implanted port allows obese patients to ... have been unable to lose weight and maintain weight loss using nonsurgical treatments. The FDA approval is for ...

  1. Drugs Approved for Kidney (Renal Cell) Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Kidney (Renal Cell) Cancer This page lists cancer drugs ... that are not listed here. Drugs Approved for Kidney (Renal Cell) Cancer Afinitor (Everolimus) Aldesleukin Avastin (Bevacizumab) ...

  2. 40 CFR 49.10702 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Shoshone-Bannock Tribes of the Fort Hall Indian Reservation of Idaho § 49.10702 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Fort Hall...

  3. Epclusa Approved for Chronic Hepatitis C

    MedlinePlus

    ... news/fullstory_159609.html Epclusa Approved for Chronic Hepatitis C Combination drug treats six major forms of ... to treat the six major strains of chronic hepatitis C virus (HCV). Epclusa combines sofosbuvir, FDA-approved ...

  4. 40 CFR 52.572 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... PROMULGATION OF IMPLEMENTATION PLANS Georgia § 52.572 Approval status. With the exceptions set forth in this subpart, the Administrator approves Georgia's plans for the attainment and maintenance of the...

  5. 40 CFR 52.572 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... PROMULGATION OF IMPLEMENTATION PLANS Georgia § 52.572 Approval status. With the exceptions set forth in this subpart, the Administrator approves Georgia's plans for the attainment and maintenance of the...

  6. 40 CFR 52.572 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... PROMULGATION OF IMPLEMENTATION PLANS Georgia § 52.572 Approval status. With the exceptions set forth in this subpart, the Administrator approves Georgia's plans for the attainment and maintenance of the...

  7. 40 CFR 52.572 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... PROMULGATION OF IMPLEMENTATION PLANS Georgia> § 52.572 Approval status. With the exceptions set forth in this subpart, the Administrator approves Georgia's plans for the attainment and maintenance of the...

  8. 40 CFR 1033.210 - Preliminary approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... information supporting a different decision. (c) If you request preliminary approval related to the upcoming... model year more than three years ahead of time. (d) You must obtain preliminary approval for your...

  9. 40 CFR 49.11072 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Confederated Tribes of the Warm Springs Reservation of Oregon § 49.11072 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Warm Springs Reservation....

  10. 38 CFR 21.7220 - Course approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... course of education, including the class schedules of a resident course not leading to a standard college degree, offered by an educational institution must be approved by— (i) The State approving agency for...

  11. 40 CFR 49.10492 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Gamble Indian Community of the Port Gamble Reservation, Washington § 49.10492 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Port...

  12. 40 CFR 49.10042 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Implementation Plan for the Cow Creek Band of Umpqua Indians of Oregon § 49.10042 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Reservation of the...

  13. 40 CFR 49.10042 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Implementation Plan for the Cow Creek Band of Umpqua Indians of Oregon § 49.10042 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Reservation of the...

  14. 40 CFR 49.10042 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Implementation Plan for the Cow Creek Band of Umpqua Indians of Oregon § 49.10042 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Reservation of the...

  15. 40 CFR 49.10042 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Implementation Plan for the Cow Creek Band of Umpqua Indians of Oregon § 49.10042 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Reservation of the...

  16. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval...-assigned color code. (b) Approved ventilation tubing shall be legibly and permanently marked on...

  17. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval...-assigned color code. (b) Approved ventilation tubing shall be legibly and permanently marked on...

  18. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval...-assigned color code. (b) Approved ventilation tubing shall be legibly and permanently marked on...

  19. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval...-assigned color code. (b) Approved ventilation tubing shall be legibly and permanently marked on...

  20. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.29 Approval...-assigned color code. (b) Approved ventilation tubing shall be legibly and permanently marked on...

  1. Epclusa Approved for Chronic Hepatitis C

    MedlinePlus

    ... fullstory_159609.html Epclusa Approved for Chronic Hepatitis C Combination drug treats six major forms of HCV ... treat the six major strains of chronic hepatitis C virus (HCV). Epclusa combines sofosbuvir, FDA-approved in ...

  2. 7 CFR 51.49 - Approved identifications.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ...) Grade marks. The approved shield mark with the appropriate U.S. grade designation may be used on... the shield. The shields with approved grade designation for use shall be similar in form and design...

  3. 7 CFR 51.49 - Approved identifications.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...) Grade marks. The approved shield mark with the appropriate U.S. grade designation may be used on... the shield. The shields with approved grade designation for use shall be similar in form and design...

  4. Effect of soy isoflavone supplementation on nitric oxide metabolism and blood pressure in menopausal women

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Isoflavones, having chemical structures similar to estrogens, are believed to stimulate nitric oxide production and thus lower blood pressure. The efficacy of soy isoflavone supplementation to stimulate nitric oxide production and lower blood pressure in menopausal women with high normal blood press...

  5. Effect of mineral supplementation on the performance by stocker cattle grazing winter wheat pasture

    Technology Transfer Automated Retrieval System (TEKTRAN)

    To evaluate the efficacy of mineral supplementing stocker cattle grazing wheat pasture, 2 experiments were conducted. In Exp 1, 72 steer and heifer calves (avg BW = 228 kg) were randomly assigned to 12, 4.9-ha pastures on November 12 at 1.2 calves/ha (4 pastures), and February 5 at 2.5 calves/ha (8...

  6. Recent Advances in Berry Supplementation and Age-Related Cognitive Decline

    Technology Transfer Automated Retrieval System (TEKTRAN)

    To summarize recent findings and current concepts in the beneficial effects of berry consumption on brain function during aging. Berryfruit supplementation has continued to demonstrate efficacy in reversing age-related cognitive decline in animal studies. In terms of the mechanisms behind the effe...

  7. Prophylactic Supplementation of Caprylic Acid in Feed Reduces Salmonella Enteritidis Colonization in Commercial Broiler Chicks

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Salmonella Enteritidis is a major foodborne pathogen for which chickens serve as reservoir hosts. Reducing Salmonella Enteritidis carriage in chickens would reduce contamination of poultry meat and eggs with this pathogen. We investigated the prophylactic efficacy of feed supplemented with caprylic ...

  8. A Prekindergarten Curriculum Supplement for Enhancing Mainstream American English Knowledge in Nonmainstream American English Speakers

    ERIC Educational Resources Information Center

    Edwards, Jan R.; Rosin, Peggy

    2016-01-01

    Purpose: The purpose of this study was to evaluate the efficacy of a curriculum supplement designed to enhance awareness of Mainstream American English (MAE) in African American English- (AAE-) speaking prekindergarten children. Method: Children in 2 Head Start classrooms participated in the study. The experimental classroom received the Talking…

  9. A Randomized Controlled Trial of a Behavioral Economic Supplement to Brief Motivational Interventions for College Drinking

    ERIC Educational Resources Information Center

    Murphy, James G.; Dennhardt, Ashley A.; Skidmore, Jessica R.; Borsari, Brian; Barnett, Nancy P.; Colby, Suzanne M.; Martens, Matthew P.

    2012-01-01

    Objective: Behavioral economic theory suggests that a reduction in substance use is most likely when there is an increase in rewarding substance-free activities. The goal of this randomized controlled clinical trial was to evaluate the incremental efficacy of a novel behavioral economic supplement (Substance-Free Activity Session [SFAS]) to a…

  10. Soy isoflavone supplementation and bone mineral density in menopausal women: a 2-y multicenter clinical trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Isoflavones are naturally occurring plant estrogens that are abundant in soy. Although purported to protect against bone loss, the efficacy of soy isoflavone supplementation in the prevention of osteoporosis in postmenopausal women remains controversial. Our aim was to test the effect of soy isoflav...

  11. Marketing approval for the lithotripter.

    PubMed

    Nightingale, S L; Young, F E

    1986-01-01

    In December 1984, the Food and Drug Administration (FDA) granted Dornier Systems (FRG) approval to market the external shock wave lithotripter (ESWL) in the USA. The Medical Device Amendments of the Food, Drug, and Cosmetic Act require that the FDA evaluate the safety and effectiveness of medical devices intended for commercial distribution in the U.S. Such evaluation includes basic scientific studies, animal testing, and investigational studies in human subjects, culminating in a judgment concerning acceptable risks in terms of anticipated benefits, and whether the device is effective for its intended use. Prior to human studies in West Germany, Dornier had evaluated the destruction of stones of varying composition, measured the rate and energy of stone destruction, and tested blood samples and lymphocyte cultures exposed to shock waves. In addition, studies in both rats and dogs had demonstrated the feasibility of the technique and evidence of safety. Such data are provided by manufacturers when applying for an investigational device exemption (IDE) from the FDA, which permits clinical studies in humans; such studies also require the approval of an Institutional Review Board. The FDA approved Dornier's IDE, allowing human investigational use of the ESWL in facilities in the U.S., conducted concurrently with similar studies in West Germany. Upon completion of clinical trials, data acquired in vitro, in laboratory animals, and in human investigations are submitted to the FDA for a premarked approval application (PMAA). The Agency was given 6 months to make a decision, taking into consideration the recommendation of an advisory panel of experts from outside the Agency who had reviewed the same data. In its evaluation of the ESWL for safety and effectiveness, the FDA considered the question of alternative practices and procedures to treat nephrolithiasis, including percutaneous nephrolithotomy and open surgical procedures, and the adverse effects of such procedures

  12. Dietary supplements containing prohibited substances.

    PubMed

    van der Bijl, P; Tutelyan, V A

    2013-01-01

    Dietary supplement use among athletes to enhance performance is proliferating as more individuals strive for obtaining that chemical competitive edge. As a result the concomitant use of dietary supplements containing performance-enhancing substances of those falling in the categories outlined in the current review, can also be expected to rise. This despite ever-increasing sophisticated analytical methodology techniques being used to assay dietary supplement and urine samples in doping laboratories. The reasons for this include that a variety of these chemical entities, many of them on the prohibited drug list of the WADA, are being produced on commercial scales in factories around the world (ephedrine and pseudoephedrine, sibutramine, methylhexaneamine, prohormones, 'classic' anabolic steroids, clenbuterol, peptide hormones etc.), aggressive marketing strategies are being employed by companies and these supplements can be easily ordered via e.g. the internet. It can also be anticipated that there will be an increase in the number of supplements containing 'designer' steroids and other 'newer' molecules. Chromatographic techniques combined with mass spectrometry leading to identification of molecular fragments and productions will assist in determining these substances. To prevent accidental doping, information regarding dietary supplements must be provided to athletes, coaches and sports doctors at all levels of competition. The risks of accidental doping via dietary supplement ingestion can be minimized by using 'safe' products listed on databases, e.g. such as those available in The Netherlands and Germany. PMID:24741950

  13. Motivators and barriers to prenatal supplement use among minority women in the United States.

    PubMed

    Tessema, Judith; Jefferds, Maria Elena; Cogswell, Mary; Carlton, Ewa

    2009-01-01

    Minority women in the United States are at a higher risk of iron deficiency and less likely to report use of prenatal supplements compared with non-Hispanic white women. Little information exists on the perceived benefits and barriers to prenatal supplement use. We analyzed the results of 12 focus groups conducted with African-American and Hispanic women (n=104). Groups were equally divided into consistent (five to seven times per week for 3 or more months) and inconsistent (zero to four times per week for 0 to 2 months) users and by race/ethnicity. We examined motivators and barriers to prenatal supplement use and identified common themes; we also compared responses between consistent and inconsistent users, and between African American and Hispanic women. For all groups, positive effects, convenient supply, affordability, and reinforcement by health care providers enhanced adherence. Common barriers were prenatal supplement qualities, adverse effects, and poor communication from health care providers about the benefits of use. Common motivators among consistent users included social network reinforcement of daily intake and fear of adverse effects to the fetus if prenatal supplements were not taken. Common barriers among inconsistent users included skepticism toward the efficacy and necessity of prenatal supplements and the health care provider assenting to nonadherence. Prenatal supplement use was influenced by multiple factors in women's daily lives. Adherence will likely be enhanced by reducing barriers related to prenatal supplement qualities and adverse effects, improving social network support, and improving health care provider interactions. PMID:19103329

  14. 30 CFR 7.311 - Approval checklist.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval checklist. 7.311 Section 7.311 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Electric Motor Assemblies § 7.311 Approval...

  15. 40 CFR 52.2062 - Plan approvals.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Plan approvals. 52.2062 Section 52.2062... PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Pennsylvania § 52.2062 Plan approvals. (a) Emission limitations and related provisions which are established in Pennsylvania plan approvals as...

  16. 40 CFR 52.2062 - Plan approvals.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 4 2011-07-01 2011-07-01 false Plan approvals. 52.2062 Section 52.2062... PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Pennsylvania § 52.2062 Plan approvals. (a) Emission limitations and related provisions which are established in Pennsylvania plan approvals as...

  17. 40 CFR 52.2062 - Plan approvals.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 5 2012-07-01 2012-07-01 false Plan approvals. 52.2062 Section 52.2062... PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Pennsylvania § 52.2062 Plan approvals. (a) Emission limitations and related provisions which are established in Pennsylvania plan approvals as...

  18. 12 CFR 611.510 - Approval procedures.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Approval procedures. 611.510 Section 611.510 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM ORGANIZATION Transfer of Authorities § 611.510 Approval procedures. (a) Upon receipt of approval of a resolution by the Farm...

  19. 30 CFR 18.11 - Approval plate.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES General Provisions § 18.11 Approval... the applicant, and spaces for the approval number, serial number, and the type or model of machine. (2... equipment. (c) The approval plate identifies as permissible the machine or accessory to which it is...

  20. 30 CFR 18.11 - Approval plate.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES General Provisions § 18.11 Approval... the applicant, and spaces for the approval number, serial number, and the type or model of machine. (2... equipment. (c) The approval plate identifies as permissible the machine or accessory to which it is...