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

11:09 EDT 20th September 2018 | BioPortfolio

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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...

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.

Analyzing Approaches to the Backlog of Untested Sexual Assault Kits in the U.S.A.

Motivated by the debate over how to deal with the huge backlog of untested sexual assault kits in the U.S.A., we construct and analyze a mathematical model that predicts the expected number of hits (i.e., a new DNA profile matches a DNA sample in the criminal database) as a function of both the proportion of the backlog that is tested and whether the victim-offender relationship is used to prioritize the kits that are tested. Refining the results in Ref. (Criminol Public Policy, 2016, 15, 555), we use data ...

Effect of European Medicines Agency's regulatory measures on nimesulide utilization in Portugal.

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.

Evaluation of four commercial DNA extraction kits for the detection of Microsporidia and the importance of pretreatments in DNA isolation.

Microsporidia are obligate intracellular parasitic protozoa infecting the wide variety of hosts and are commonly known as a cause of chronic diarrhea particularly in immunocompromised individuals. Molecular-based tests have high sensitivity and specificity in disease diagnosis. However, these tests' performance relies on the isolation of DNA in a good concentration. The standard procedures of commercial DNA extraction kits are usually insufficient for this purpose due to the tough walls of spores. This stud...

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.

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...

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...

Brief Report: Reliability of the Participation and Sensory Environment Questionnaire: Home Scales.

The Participation and Sensory Environment Questionnaire: Home Scales (P-SEQ): Home Scales is a parent report tool designed to assess the impact of the sensory environment on participation in daily activities in the home of children with and without autism spectrum disorder. A cross-sectional study was completed to determine internal consistency, test-retest reliability, and examine item distribution. A total of 304 parents of children between the ages of 2 and 7 years of age completed the P-SEQ: Home Scale...

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.

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 ...

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...

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...

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 ...

Effective Home Visiting Training: Key Principles and Findings to Guide Training Developers and Evaluators.

Purpose Home visiting programs have produced inconsistent outcomes. One challenge for the field is the design and implementation of effective training to support home visiting staff. In part due to a lack of formal training, most home visitors need to develop the majority of their skills on the job. Home visitors typically receive training in their agency's specific model (e.g., HFA, NFP) and, if applicable, curriculum. Increasingly, states and other home visiting systems are developing and/or coordinating ...

Longitudinal Associations of Autonomy, Relatedness, and Competence with the Well-being of Nursing Home Residents.

As proposed by the self-determination theory, satisfying nursing home residents' needs for autonomy, relatedness, and competence may improve their well-being. This is the first study to test the longitudinal relations of the satisfaction of these three basic psychological needs to the subjective well-being of nursing home residents and to determine whether a balance among the satisfaction of the three needs is important for well-being.

Essential medicines availability is still suboptimal in many countries: A scoping review.

To identify uses of WHO Model list of essential medicines (EM) and summarize studies examining essential medicines (EM) and national EM lists (NEMLs).

Spanish Society of Hospital Pharmacy position paper on biosimilar medicines.

Biological medicines nowadays have a great impact, as they offer treatment for  diverse diseases and suppose a high cost for health system. Biosimilar medicines contain a version of an active substance already authorized as an original  biotechnological medicine, whose patent has expired, and they comply with the  guidelines published by the European Medicines Agency. These guidelines, where biosimilarity criteria are established, guarantee comparability between biosimilar product and reference on...

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