Margaret Hamburg to resign from FDA’s top post
WASHINGTON — Food and Drug Commissioner Margaret Hamburg will resign from her post in March. Stephen Ostroff, the FDA’s chief scientist and a former official at the Centers for Disease Control and Prevention, will take over in the top post until President Obama names a successor for Hamburg, The Washington Post reported Thursday.
“As you can imagine, the decision was not easy,” Hamburg said in a statement. “While there is still work ahead (and there will always be), I know that I am leaving the agency well-positioned to fulfill its responsibilities to the American public with great success.”
Hamburg, 59, is among the longest-serving commissioners at the agency. A Harvard Medical School graduate, she previously worked as New York City’s health commissioner, as well as at the National Institutes of Health, The Washington Post reported.
NSF defines optimal sleep durations by age
WASHINGTON — The National Sleep Foundation, along with a multidisciplinary expert panel, recently issued its new recommendations for appropriate sleep durations. The report recommends wider appropriate sleep ranges for most age groups. The results are published in Sleep Health: The Official Journal of the National Sleep Foundation.
The National Sleep Foundation convened experts from sleep, anatomy and physiology, as well as pediatrics, neurology, gerontology and gynecology, to reach a consensus from the broadest range of scientific disciplines. The panel revised the recommended sleep ranges for all age groups. A summary of the new recommendations includes:
- Newborns (0-to-3 months): Sleep range narrowed to 14-to-17 hours each day (previously it was 12-to-18);
- Infants (4-to-11 months): Sleep range widened two hours to 12-to-15 hours (previously it was 14-to-15);
- Toddlers (1-to-2 years): Sleep range widened by one hour to 11-to-14 hours (previously it was 12-to-14);
- Preschoolers (3-to-5 years): Sleep range widened by one hour to 10-to-13 hours (previously it was 11-to-13);
- School-age children (6-to-13 years): Sleep range widened by one hour to 9-to-11 hours (previously it was 10-to-11);
- Teenagers (14-to-17 years): Sleep range widened by one hour to 8-to-10 hours (previously it was 8.5-to-9.5);
- Younger adults (18-to-25 years): Sleep range is 7-to-9 hours (new age category);
- Adults (26-to-64 years): Sleep range did not change and remains 7-to-9 hours; and
- Older adults (65+ years): Sleep range is 7-to-8 hours (new age category).
“This is the first time that any professional organization has developed age-specific recommended sleep durations based on a rigorous, systematic review of the world scientific literature relating sleep duration to health, performance and safety,” stated Charles Czeisler, chairman of the board of the National Sleep Foundation, chief of sleep and circadian disorders at Brigham and Women’s Hospital, and Baldino Professor of Sleep Medicine at the Harvard Medical School. “The National Sleep Foundation is providing these scientifically grounded guidelines on the amount of sleep we need each night to improve the sleep health of the millions of individuals and parents who rely on us for this information.”
A new range, “may be appropriate,” has been added to acknowledge the individual variability in appropriate sleep durations. The recommendations now define times as either (a) recommended; (b) may be appropriate for some individuals; or (c) not recommended.
“The National Sleep Foundation Sleep Duration Recommendations will help individuals make sleep schedules that are within a healthy range. They also serve as a useful starting point for individuals to discuss their sleep with their health care providers,” said David Cloud, CEO of the National Sleep Foundation.
The recommendations are the result of multiple rounds of consensus voting after a comprehensive review of published scientific studies on sleep and health.
“The NSF has committed to regularly reviewing and providing scientifically rigorous recommendations,” said Max Hirshkowitz, chair of the National Sleep Foundation Scientific Advisory Council. “The public can be confident that these recommendations represent the best guidance for sleep duration and health.”
Acura Pharmaceuticals launches combination PSE with anti-meth formulation
PALATINE, Ill. — Acura Pharmaceuticals on Thursday announced the launch of their second pseudoephedrine product, Nexafed Sinus Pressure + Pain (pseudoephedrine HCI 30 mg + acetaminophen 325 mg), a meth-resistant immediate-release tablet that effectively relieves congestion due to colds and allergies, as well as pain and/or fever associated with colds and sinus headaches.
Nexafed Sinus Pressure + Pain will continue to utilize Nexafed's patented Impede technology that disrupts the conversion of PSE into methamphetamine, and will be the first meth-resistant PSE combination sinus medicine available.
"Nexafed Sinus Pressure + Pain gives pharmacists the only meth-resistant combination cold medication with pseudoephedrine on the market," stated Bob Jones, president of Acura Pharmaceuticals. "We are excited to offer pharmacists and consumers a sinus medication with the main ingredient they have relied on to treat their congestion for years combined with acetaminophen to treat pain associated with sinus congestion and pressure, all while fighting meth."
Nexafed is currently available nationwide in drug, mass merchandiser and grocery stores with pharmacies. And in some states like West Virginia, nearly all pharmacies have chosen to replace single ingredient PSE products with meth-resistant products such as Nexafed to counter the impact of meth production felt statewide.
"When NEXAFED replaces traditional, non-meth-resistant PSE products in pharmacies, patients get the same relief they expect, but meth cooks have to look elsewhere for the older products they prefer," Jones said. "This has led to a significant reduction in local meth labs as documented by state and county officials in 2014."
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