martes, 28 de febrero de 2017

Public Comment on Draft Recommendation Statement and Draft Evidence Review: Vision Screening in Children Ages 6 Months to 5 Years

Opportunity for Public Comment - US Preventive Services Task Force
U.S. Preventive Services Task Force banner
February 28, 2017 − The U.S. Preventive Services Task Force seeks comments 
on a draft recommendation statement and draft evidence review on vision 
screening in children ages 6 months to 5 years. The Task Force found that 
clinicians should conduct vision screening in children ages 3 to 5 years and
found insufficient evidence to recommend for or against screening in younger 
children. The draft recommendation statement and draft evidence review 
are available for review and public comment from February 28 through 
March 27, 2017 at http://www.uspreventiveservicestaskforce.org/Page/Name/us-preventive-services-task-force-opportunities-for-public-comment.

PDQ Updates for Health Professionals

PDQ Updates for Health Professionals

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PDQ Updates for Health Professionals from the National Cancer Institute. NCI newly published or updated these health professional summaries within the last week.

Extreme temperatures may increase risk for low birth weight at term, NIH study suggests | National Institutes of Health (NIH)

Extreme temperatures may increase risk for low birth weight at term, NIH study suggests | National Institutes of Health (NIH)

National Institutes of Health (NIH) - Turning Discovery into Health



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Extreme temperatures may increase risk for low birth weight at term, NIH study suggests

Extreme hot or cold temperatures during pregnancy may increase the risk that infants born at term will be of low birth weight, according to a study of U.S. women by researchers at the National Institutes of Health. The study was published in Environmental Research.
The authors found that exposure to atypically cold temperature during the entire pregnancy, or just during the second trimester and third trimester, increased the risk for low birth weight. Exposure to atypically hot temperatures during the whole pregnancy, or during the third trimester, also increased this risk. The odds for low term birth weight were highest when the whole pregnancy was exposed to extreme temperatures.
“Until we can learn more, it makes sense to reduce the amount of time that pregnant women are exposed to extreme hot or cold weather,” said the study’s senior author, Pauline Mendola, Ph.D., an epidemiologist in the Division of Intramural and Population Health Research at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Low birth weight(link is external) refers to infants weighing less than 5.5 lbs. at birth. Infants may be of low birth weight because they are born prematurely, while others may be of low birth weight even though they have completed the 37-40 weeks that is considered to be a term pregnancy. Some are otherwise healthy, but are genetically predisposed to small size. Others are of low birth weight because of an underlying health problem—illness, infection or a failure to grow in the womb. Compared to infants of normal weight, low birth weight infants may be at higher risk for infection and developmental delays.
In the current study, NICHD researchers linked medical records from 223,375 births at 12 U.S. clinical centers to hourly temperature records for the region surrounding each center. They defined extreme cold as below the 10th percentile of average temperatures for a region; extreme heat was above the 90th percentile.
Infants born at term to mothers exposed to cold during either the second or third trimester were 18 to 21 percent more likely to be of low birth weight. When exposed to extended cold over the entire pregnancy, term infants were 257 percent more likely to be of low birth weight.
Term infants exposed to heat in the third trimester were 31 percent more likely to be of low birth weight, and infants born after the entire pregnancy occurred during atypically hot temperatures were 249 percent more likely to be of low birth weight.
Researchers do not know why exposure to atypically high or low temperatures would affect birth weight. The authors noted that previous studies have suggested that heat exposure could affect birth weight by increasing oxidative stress — toxic byproducts formed when oxygen interacts with cells and tissues — and by increasing inflammation. It is also possible that temperature extremes could reduce blood flow to the uterus, depriving the infant of oxygen and nutrients and hindering the placenta’s ability to remove fetal wastes.
The study adds to the researchers’ 2016 analysis of the same data in which they reported that extreme heat and cold may increase the risk of preterm birth.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD conducts and supports research in the United States and throughout the world on fetal, infant and child development; maternal, child and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit NICHD’s website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIH…Turning Discovery Into Health®

February 27, 2017 | FDA Medical Countermeasures Initiative Update

New FDA Logo Blue

February 27, 2017  |  FDA Medical Countermeasures Initiative Update

Organ-on-chip (Image: Wyss Institute for Biologically Inspired Engineering)


New funding opportunity (BAA)

To help develop solutions to complex regulatory science challenges, FDA funds medical countermeasure (MCM)-related research through intramural and extramural research grants.
Extramural MCM regulatory science is primarily funded through a Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation, under area 7: Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security.
The current BAA announcement was posted on February 23, 2017, and will remain open until further notice.
Related Information
Image: Organ-on-a-chip held between thumb and forefinger. In one ongoing FDA BAA project, Harvard University's Wyss Institute for Biologically Inspired Engineering is testing candidate radiation MCMs using novel organs-on-chips technology. (Credit: Wyss)

New public workshop - March 1, 2017

Silver Spring, MD and webcast
FDA is conducting this workshop to facilitate the development of narrow-spectrum antibacterial drugs, such as those that are active against only a single species of bacteria that may not occur frequently. When the species occurs infrequently, performing clinical trials can be extremely challenging. Therefore, animal models of infection may be useful to explore the activity of a candidate antibacterial drug and may help to predict whether the drug will be efficacious in humans.
Pseudomonas aeruginosa bacteria (CDC)
Events
  • March 8-9, 2017: Examining Opportunities for the Future of Medical and Public Health Preparedness: A Workshop (Washington, DC), hosted by the National Academies of Sciences, Engineering and Medicine, Health and Medicine Division
  • March 9, 2017: Vaccines and Related Biological Products Advisory Committee (Rockville, MD and webcast) - the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017-2018 influenza season
  • New! March 14-17, 2017: FDA/Xavier University PharmaLink conference Increasing Product Confidence (Cincinnati, OH) - the conference will engage those involved in FDA-regulated global supply chain quality and management (fee)
  • New! March 21-22, 2017: Free Emerging Infectious Disease Preparedness Training  (Omaha, NE), for healthcare workers and public health officials, hosted by CDC and the National Ebola Training & Education Center (more training dates/registration info)
  • New! April 3-4, 2017: Free Emerging Infectious Disease Preparedness Simulation Training  (New York, NY), for clinicians, hosted by CDC and the National Ebola Training & Education Center
  • April 6, 2017: Public workshop - Emerging Tick-Borne Diseases and Blood Safety(Bethesda, MD) - to discuss tick-borne pathogens that continue to emerge as threats to blood safety, the effectiveness of current and potential mitigation strategies, and the general approach to decision making on blood safety interventions - register by March 23, 2017
  • New! April 24-26, 2017: 20th Annual Conference on Vaccine Research  (Bethesda, MD), hosted by the National Foundation for Infectious Diseases - includes presentations on development and approval pathways of vaccines to prevent infectious diseases (FDA's Marion Gruber, PhD, is presenting), and evaluating vaccine safety during public health emergencies (fee)
  • April 25-28, 2017: Preparedness Summit  (Atlanta, GA) - FDA's Gregory Measer, JD, will present Beyond the Last Mile: Monitoring and Assessing Medical Countermeasure Use in Response to Public Health Emergencies (fee)
  • New - save the date! May 31 - June 1, 2017: FDA Science Forum (Silver Spring, MD) - The Forum will highlight the breadth and depth of cutting-edge science FDA conducts and will demonstrate how FDA's scientific research informs our regulatory decision-making.
In case you missed it
  
Course instructor assists student during FDA UTMB data quality course
  • From NIH - NIH Begins Study of Vaccine to Protect Against Mosquito-Borne Diseases - NIAID has launched a Phase 1 clinical trial to test an investigational vaccine intended to provide broad protection against a range of mosquito-transmitted diseases, such as Zika, malaria, West Nile fever and dengue fever, and to hinder the ability of mosquitoes to transmit such infections. (February 21, 2017)
  • From NIAID - Cellular Therapies for Treatment of Radiation Injuries - The purpose of this Funding Opportunity Announcement (FOA) is to support studies to evaluate candidate cellular therapies to treat radiation-induced injuries in appropriate in vivo models when administered 24 hours or more post-irradiation. Letters of intent due July 1, 2017.
  • The National Institute for Occupational Safety and Health (NIOSH) of the CDC announced the availability of a draft web-based database entitled PPE-Info for public comment. The PPE-Info Database serves as a compendium of Federal regulations and consensus standards for Personal Protective Equipment (PPE). Comment by April 13, 2017.
  • Did you know... FDA scientists invent. 32 patents issued in 2016.

Ivanhoe's First to Know for 2/27/2017

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Doctor's In-depth Interview of the week
 
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Quote of the week:

“The struggle in caring for people is more often with what you do not know than what you do. Medicine's ground state is uncertainty. And wisdom - for both patients and doctors - is defined by how one copes with it.” 

— Atul Gawande

 


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