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PubMed Journals Articles About "Medicines Agency Seizes Home Test Kits Over False" RSS

03:25 EST 17th December 2018 | BioPortfolio

Medicines Agency Seizes Home Test Kits Over False PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Medicines Agency Seizes Home Test Kits Over False articles that have been published worldwide.

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Showing "medicines agency seizes home test kits over false" PubMed Articles 1–25 of 10,000+

Assessing the performance of only HRP2 and HRP2 with pLDH based rapid diagnostic tests for the diagnosis of malaria in middle Ghana, Africa.

Rapid diagnostic test (RDT) kits have been useful tools to screen for the presence of infection with malaria parasites. Despite the improvement, false results from RDTs present a greater challenge. The need for quality test kits is desirable. We evaluated the diagnostic accuracy of three malaria RDTs.


Home Visiting: Improving Children's and Families' Well-Being.

(1) Studies have found a $1.80 to $5.70 return on investment for every dollar spent on home visiting. (2) Nearly 4 million evidence-based home visits reached more than 300,000 families in 2016. (3) Approximately 40 percent of U.S. counties have at least one home visiting agency that offers an evidence-based program.

What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.

The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the European Medicines Agency (EMA) have a long-standing experience of reviews of new medicines, and they meet their target pre-market review periods. In FY 2016 / 2016, 112 and 83 new medicines were approved in Japan and EU, respectively. Out of these medicines, 41 and 27 medicines containing new active ingredients were approved with total pre-market review periods of 209 days and 428 days in Japan and EU, respectively. Approximately one-th...


Impact of Brexit on UK and EU Drug Regulation and Patient Access.

The chronology of U.K. leaving the European Union Is presented together with its implications for medicines regulation, including the move of the European Medicines Agency from London to Amsterdam, The legal and political options for the UK and the EU are discussed, which at the time of writing (October 2018) are both uncertain, Of importance is the response of the pharmaceutical industry and the possible consequences for UK patients, including delays in access to innovative medicines and an increase in dru...

Pharmacists and patients sharing decisions about medicines: Development and feasibility of a conversation guide.

In Australia, the Home Medicines Review (HMR) is a nationally-funded program, led by pharmacists to optimize medication use for older people. A Medicines Conversation Guide was developed for pharmacists to use in the context of a HMR. The Guide aims to increase patient involvement and support discussions about: general health understanding, decision-making and information preferences, health priorities related to medicines, patient goals and fears, views on important activities and trade-offs.

The European Medicines Agency and Family Doctors.

A pilot trial of the peer-based distribution of HIV self-test kits among fishermen in Bulisa, Uganda.

HIV self-testing (HIVST) addresses barriers to HIV diagnosis among men, but current approaches to distributing HIVST kits only reach a subset of the men requiring testing.

False memory at short and long term.

False memories are well-established long-term memory (LTM) phenomena. Recent reports of false recognition at short term suggest that working memory (WM) could also give rise to false memories, supporting the unitary view of memory. Alternatively, we hypothesized that the emergence of false memories at short term results from the impairment of WM maintenance, memory performance relying then on LTM. More specifically, we assumed that false memories rely on the retrieval of gist traces of the memory items whil...

Marketing authorisation applications submitted to the European Medicines Agency by small and medium-sized enterprises: an analysis of major objections and their impact on outcomes.

Small and medium-sized enterprises (SMEs) are an important source of innovative medicines. Compared with their larger counterparts, they experience challenges as a result of insufficient human and financial resources that can hamper drug development and regulatory compliance. This analysis reviews the profile of major objections raised in applications for medicines for human use submitted by SMEs to the European Medicines Agency between 2011 and 2015 and their impact on the outcome of applications. It showe...

Using a Social Network Strategy to Distribute HIV Self-Test Kits to African American and Latino MSM.

Men who have sex with men (MSM) continue to be disproportionately impacted globally by the HIV epidemic. Studies suggest that HIV Self-testing (HIVST) is highly acceptable among MSM. Social network strategies to increase testing are effective in reaching MSM, particularly MSM of color, who may not otherwise test. We tested a social-network based strategy to distribute HIVST kits to African American and Latino MSM.

Quality of medicines: Deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections.

The circulation of poor quality medicines, especially in the developing countries, is a public health concern. Compliance with good manufacturing practices (GMP) is essential to ensure the quality, efficacy, and safety of medicines. This study evaluated the outcomes of the Brazilian Health Regulatory Agency's (ANVISA) international inspections of two years (2015 and 2016) and compared these to those of other regulatory authorities. The information from 255 inspection reports was analyzed, and the type and e...

Improving STD service delivery: Would American patients and providers use self-tests for gonorrhea and chlamydia?

Chlamydia trachomatis (CT) and Neisseria gonorrhea (GC) are the most frequently reported notifiable diseases in the United States and costs for diagnosis and treatment of these two infections are approximately $700 million per year. A proposed new method for screening for these two infections is self-tests; similar to at-home pregnancy and HIV tests which do not include sending collected specimens to a laboratory for diagnosis. However, no such self-tests for sexually transmitted diseases (STD) have been ap...

Can Aspergillus fumigatus conidia cause false-positive results in the galactomannan enzyme immunoassay test?

Several factors can cause false-positive results in the galactomannan (GM) test; however, others remain unknown. Presently, the impact of airborne contamination by Aspergillus conidia during enzyme-linked immunosorbent assay (ELISA) remains uninvestigated.

Does consumer medicines interest reflect medicines use? An Australian observational study comparing medicines call center queries with medicines use.

Consumers have questions about their medication but the nature of these concerns and how they reflect medication use is unknown.

Medical Devices; Exemption From Premarket Notification; Class II Devices; Over-the-Counter Denture Repair Kit. Final order.

The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for over-the-counter (OTC) denture repair kits (Product Code EBO). These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to mend cracks or breaks. This order exempts OTC denture repair kits, class II devices, from premarket notification (510(k)). This exemption...

Access to medicines for acute illness and antibiotic use in residents: A medicines household survey in Sichuan Province, western China.

To investigate medicine accessibility and antibiotic use in households in western China using World Health Organization (WHO) methodology as well as to identify the influencing factor of care-seeking outside the home and primary determinant factors that influence the use of antibiotics in Chinese residents.

Preparing Clinicians for Transitioning Patients Across Care Settings and Into the Home Through Simulation.

Assuring home care staff competencies through simulation has the potential to improve care transitions and clinical outcomes. Recreating a home environment can be used for orientation of home care staff and to meet other learning needs. Lessons learned from the use of simulation in a geriatric nursing course in a prelicensure program can be used to prepare clinicians for transitioning patients across care settings. With simulation, learners can identify challenges in patient safety, pain management, and man...

Naloxone Effectiveness: A Systematic Review.

Opioid abuse and overdose is a public health concern as it relates to increased morbidity and mortality. This systematic review focuses on the application of take-home naloxone programs and its association with decreased mortality among those who abuse opioids. Take-home naloxone programs consist of distributed naloxone kits and corresponding education of overdose recognition. The purpose of this systematic review was to determine if programs that supply take-home naloxone are effective in preventing fatal ...

Home-versus acquired-language test performance on the Hopkins Verbal Learning Test-Revised among multilingual South Africans.

The Hopkins Verbal Learning Test-Revised (HVLT-R) has been adapted for use in many different languages and in low- and middle-income countries. However, few adaptations have evaluated performance differences between home- and acquired-language administrations. The present study examined performance on an adapted HVLT-R between multilingual South Africans who chose to be tested in a home or acquired language. The HVLT-R was administered to 112 multilingual, isiXhosa as home language, Black South African adul...

Home Self-Collection by Mail to Test for Human Papillomavirus and Sexually Transmitted Infections.

To evaluate the validity and acceptability of at-home self-collection to test for high-risk human papillomavirus (HPV) and sexually transmitted infections among women overdue for cervical cancer screening by national guidelines.

Administration of mycophenolic acid is not associated with malformations in descendants from kidney transplanted males.

In pregnant women, the use of Mycophenolic acid (MPA) is associated with teratogenicity. Recently, the European Medicines Agency (EMEA) and the Spanish Agency of Medicine and Sanitary Products (AEMPS) warned about the potential teratogenic effects of MPA. These adverse events may occur even in children from males on treatment with MPA. However, evidence of malformations in offsprings of male kidney transplanted patients (KT) exposed to MPA is limited. Thus, the present study aimed to evaluate the incidence ...

Improving the calling of non-invasive prenatal testing on 13-/18-/21-trisomy by support vector machine discrimination.

With the advance of next-generation sequencing (NGS) technologies, non-invasive prenatal testing (NIPT) has been developed and employed in fetal aneuploidy screening on 13-/18-/21-trisomies through detecting cell-free fetal DNA (cffDNA) in maternal blood. Although Z-test is widely used in NIPT NGS data analysis, there is still necessity to improve its accuracy for reducing a) false negatives and false positives, and b) the ratio of unclassified data, so as to lower the potential harm to patients as well as ...

Intellectual factors in false memories of patients with schizophrenia.

The current study explored the intellectual factors in false memories of 139 patients with schizophrenia, using a recognition task and an IQ test. The full-scale IQ score of the participants ranged from 57 to 144 (M = 100, SD = 14). The full IQ score had a negative correlation with false recognition in patients with schizophrenia, and positive correlations with high-confidence true recognition and discrimination rates. Further analyses with the subtests' scores revealed that false recognition was ne...

Influences of Community Interventions on Zika Prevention Behaviors of Pregnant Women, Puerto Rico, July 2016-June 2017.

We assessed how community education efforts influenced pregnant women's Zika prevention behaviors during the 2016 Centers for Disease Control and Prevention-Puerto Rico Department of Health Zika virus response. Efforts included Zika virus training, distribution of Zika prevention kits, a mass media campaign, and free home mosquito spraying. We used telephone interview data from pregnant women participating in Puerto Rico's Women, Infants, and Children Program to test associations between program participati...

Cognitive screening instruments: how much overdiagnosis do they create?

Overdiagnosis appears to be an umbrella term, or an overarching category with various components, such as overdetection, overdefinition, or overselling. How these qualitative elements map on to the quantitative categories (true positives and negatives, false positives and negatives) as defined in screening test accuracy studies is not clear to me. Whilst on face value overdetection might seem to be equivalent to false positives, Brodersen and his colleagues are explicit that overdiagnosis is not a false pos...


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