Current Highlight from May 15, 2015
Progress on FDA Studies Reviewed
The 45th meeting of the Toxicology Study Selection and Review Committee (TSSRC) was held at FDA's White Oak facility, May 5-6, 2015. The focus was to discuss ongoing studies that are part of the Interagency Agreement between the FDA/NCTR and the National Institute of Environmental Health Sciences/National Toxicology Program (NIEHS/NTP) that supports toxicology studies providing data for the FDA risk-assessment process.
New projects studying the following compounds were discussed and recommended to start:
- Arsenic, a contaminant in many food products and water
- Melamine and cyanuric acid, contaminants in some imported products.
Ongoing projects that were presented and discussed are studying Triclosan, an antibacterial chemical.
A proposed study on hydrochlorothiazide was deferred pending examination of available data by FDA/CDER.
NIEHS/NTP presented updates on the following studies being conducted in its Toxicology Testing Program:
- Triclocarban, an antimicrobial chemical Hydroxyurea, a drug used for treating sickle cell anemia
- 2-Ethylhexyl-p-methoxycinnamate (octinoxate), a sunscreen ingredient
- Vinpocetine, a compound found in herbal supplements (Vinca minor, periwinkle).
TSSRC is comprised of regulatory scientists and subject-matter experts from the FDA Centers (CBER, CDER, CDRH, CFSAN, CVM, and CTP), NIEHS/NTP, and the National Institutes of Health (NIH). The committee meets twice each year and is responsible for scientific oversight of study design and progress of ongoing work under this Interagency Agreement. The next TSSRC meeting will be held at the FDA NCTR campus in Jefferson, Arkansas, on October 28-29, 2015.
For additional information, please contact Paul Howard, Ph.D., Director, Office of Scientific Coordination, FDA/NCTR.
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