That 's a First: FDA Tackles STDs, Zika, and Prosthetic Joint Infection

The U.S. diagnostic market celebrated three regulatory firsts last week.  1. FDA Authorizes Marketing of First Zika Test Until now, tests for detecting Zika virus immunoglobulin (IgM) antibodies in blood were only authorized for emergency use under FDA's Emergency Use Authorization (EUA) authority. On Thursday, the agency said it has authorized marketing of the ZIKV Detect 2.0 IgM Capture ELISA under the agency's traditional premarket authority. The test is manufactured by InBios International. “At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using our emergency use authorities,” said FDA Acting Commissioner Ned Sharpless, MD. Authorizing tests under EUA allowed manufacturers and the agency to respond quickly to the Zika emergency while continuing to review the safety and effectiveness of the test under the traditional regulatory pathway.  The Zika virus is spread to people primarily through the bite of an infected Aedes species mosquito. While many people with Zika virus infection experience no symptoms, the virus can pose potentially serious risks to public health. Links between Zika virus infection and neurological complications (i.e., Guillain-Barré Syndrome), as well as microcephaly (abnormal smallness of the hea...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance IVD Source Type: news

Related Links:

Authors: Jenabi E, Bashirian S, Khazaei S, Basiri Z Abstract This meta-analysis evaluated the association between maternal pre-pregnancy body mass index (BMI) and the risk of attention deficit hyperactivity disorder (ADHD) among children and adolescents. The search strategy was conducted until December 2018 in databases of PubMed, Web of Science and Scopus. The ORs or HRs with 95% confidence intervals (CI) extracted from eligible studies used as the common measure of association among studies. A significant association was found between overweight women and risk of ADHD among children with the pooled estimates of H...
Source: Korean Journal of Pediatrics - Category: Pediatrics Tags: Korean J Pediatr Source Type: research
Publication date: Available online 18 June 2019Source: Reproductive BioMedicine OnlineAuthor(s): Alessandra Parrella, Mohamad Irani, Derek Keating, Stephen Chow, Zev Rosenwaks, Gianpiero D. PalermoAbstractResearch QuestionAlthough ooplasmic maturity has been studied for some time, it remains poorly defined. We aim to identify the competence of MII oocytes in terms of fertilization and embryo development while considering the proportional maturity of the retrieved cohort.DesignCouples treated by ICSI between 1993 and 2017 comprising female partners ≤35 years old were included. Cycles were divided into four groups accordi...
Source: Reproductive BioMedicine Online - Category: Reproduction Medicine Source Type: research
In this study, miRNome profiling suggested differential expression of 163 miRNAs (of 887 miRNAs detected) in the kidneys from pregnant mice at 6.5 days gestation when compared to non-pregnant female mice, of which 35 and 128 miRNAs were potentially down- and up-regulated, respectively. We performed network and pathway analyses of the>1700 potential mRNA targets of the differentially expressed miRNAs using MiRNet, Gene Ontology, Reactome and KEGG analyses. The mRNA targets were over-represented in numerous cellular signalling pathways, including cellular protective responses. In addition, we explored 13 and 29 potentia...
Source: Molecular Genetics and Metabolism Reports - Category: Genetics & Stem Cells Source Type: research
We described the evolution HGA excretion and tyrosine evolution in 3 AKU patients treated by very low dosage of nitisinone with regards to their daily protein intakes. We also described the first pregnancy in an AKU patient treated by nitisinone.ResultsWe found mild clinical signs of alkaptonuria on vertebra MRI in two young adults and homogentisate deposition in teeth of a 5 years old girl. Very low dose of nitisinone (10% of present recommended dose: 0.2 mg/day) allowed to decrease homogentisic acid by>90% without increasing tyrosine levels above 500 μmol/ in these three patients.InterpretationsThe analysis o...
Source: Molecular Genetics and Metabolism - Category: Genetics & Stem Cells Source Type: research
Conclusion: SOF/VEL followed by SOF/VEL/VOX leads to comparable cure rates in the overall CHC population relative to the GLE/PIB treatment pathway. Based on wholesale acquisition prices, the SOF/VEL treatment pathway led to lower lifetime costs. PMID: 31204882 [PubMed - as supplied by publisher]
Source: Expert Review of Pharmacoeconomics and Outcomes Research - Category: Health Management Tags: Expert Rev Pharmacoecon Outcomes Res Source Type: research
Conclusions: Fasting and postprandial plasma glucose screening can replace gestational diabetes mellitus screening in women who refuse to have the glucose load test. PMID: 31210349 [PubMed - in process]
Source: Eastern Mediterranean Health Journal - Category: Middle East Health Tags: East Mediterr Health J Source Type: research
Resumo O desabastecimento de medicamentos j á é considerado um problema de saúde pública e representa um obstáculo importante para a garantia do acesso a eles e, consequentemente, do direito à saúde. Sendo assim, com o intuito de compreender melhor esse fenômeno, este artigo buscou identificar, descrever e caracterizar as publicaçõe s científicas da saúde que versam sobre o tema de desabastecimento de medicamentos e identificar as lacunas de pesquisa. Para tanto, realizou-se revisão narrativa da literatura científica na base de...
Source: Physis: Revista de Saude Coletiva - Category: International Medicine & Public Health Source Type: research
Because the effects of children's exposure to intimate partner violence (IPV) carry long lasting consequences for the affected children, IPV exposure may impose a significant economic burden to localities, states, and society at large, made explicit over t...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
This article proposes new approaches to sexual violence prevention on college and university campuses in the United States. The author conducted four thought experiments about possible college sexual assault prevention strategies based on personal experien...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
In 2016, 74 million children lived in the United States. In that same year, 3.5 million children —1 in 22—experienced either an investigation or an alternative response from a state child welfare agency based on a report of suspected child maltreatme...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
More News: Allergy | Allergy & Immunology | Brain | Centers for Disease Control and Prevention (CDC) | Chlamydia | Emergency Medicine | Epidemiology | Guillain-Barr Syndrome | Health Management | Infectious Diseases | International Medicine & Public Health | Laboratory Medicine | Marketing | Medical Devices | Neurology | Neurosurgery | Orthopaedics | Outbreaks | Pregnancy | STDs | Study | USA Health | Zika Virus