NCTR Research Highlights

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Current Highlight from November 6, 2009

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NCTR Toxicology Studies Reviewed by Toxicology Study Selection and Review Committee (TSSRC)

The TSSRC met November 3-4, 2009 at FDA's White Oak campus to discuss ongoing studies and newly proposed studies that generate toxicology data to support regulatory decision-making.

Ongoing studies that were discussed included:

• bisphenol A (BPA) monomer (food contaminant)
• furan (food and tobacco smoke contaminant)
• di(2-ethylhexyl)phthalate (DEHP) (plasticizer in medical devices and environmental contaminant)
• melamine with cyanuric acid (food contaminant)
• nanoscale silver (food contaminant, medical device component/contaminant)
• bitter orange (Citrus aurantium) with caffeine (dietary supplement)
• glucosamine and chondroitin sulfate (dietary supplement)
• usnic acid and Usnea lichen (dietary supplement)
• permanent makeup inks
• AIDS therapeutics
  
  

The newly proposed studies included:

• triclosan (antibacterial component in many products)

• pediatric anesthetics: predictive rapid, in vitro assay for potential adverse effects of the pediatric anesthetics and preventive measures
• goldenseal/berberine (dietary supplement)
• cellular telephone radiation

The TSSRC is comprised of subject experts from the FDA Product Centers and ORA, scientists from the National Institute of Environmental Health Sciences (NIEHS), and invited subject matter experts from other government agencies, industry, and academia.  The committee meets twice a year and is responsible for scientific oversight of study design and progress of ongoing work.

 

Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Workshop

NCTR Director, Dr. William Slikker, Jr., and Dr. Merle Paule, Director, NCTR Division of Neurotoxicology, gave presentations at the "1^st Scientific Workshop of the SAFEKIDS Initiative" held November 4, 2009 at FDA's White Oak campus.  These presentations discussed the effects of anesthesia on the developing animal brain and the cognitive defects in rhesus monkeys following early postnatal ketamine anesthesia.