Sequencing Quality Control (SEQC2) Workshop on September 13-14, 2016
SEQC2 is an FDA-led community-wide Sequencing Quality Control consortium. The consortium aims to develop best practices with recommended standard-analysis protocols and quality-control metrics for whole-genome sequencing and target-gene sequencing technologies that will support regulatory science research and precision medicine.
September 7-9, 2016
Nanotechnology Standards and Applications
The Global Summit on Regulatory Science 2016(GSRS16) meeting on "Nanotechnology Standards and Applications" is scheduled from September 7-9, 2016, at Natcher Auditorium, National Institute of Health (NIH) Campus, Bethesda, Maryland.The GSRS16 workshop participation extends beyond global regulatory-,research-, and standards-agency researchers, to academic and industry participants.
The meeting focus is to learn about cutting-edge science and technologies that are being developed, and build upon this knowledge to develop appropriate standards for regulatory consideration. To facilitate regulatory review to enable commercialization, the GSRS16 topics include:
- a review of current standards in nanotechnology
- innovative science in drugs, devices, food, feed, and cosmetics
- panel discussions on standard research methodologies, consensus standards, and reference materials needs.
The goal of this summit is to establish practical approaches and requisite teams to facilitate development of such standards. Poster sessions are also scheduled as part of this meeting.
There is no registration fee; however, registration is required to attend the conference. If you have any questions, please contact: Roben Brooks.
Progress on FDA Studies Reviewed
The 46th meeting of the Toxicology Study Selection and Review Committee (TSSRC) was held at FDA’s White Oak facility, May 4-5, 2016, to discuss ongoing studies that are part of the Interagency Agreement between 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.
Ongoing studies at NCTR in the following areas were discussed:
- food constituents or contaminants (bisphenol A; arsenic; melamine + cyanuric acid; brominated vegetable oil)
- antibacterial chemicals (triclosan)
- dietary supplement component (aloin)
NIEHS/NTP presented updates on compounds under study at NTP that are of interest to FDA.
The TSSRC is comprised of regulatory scientists and subject-matter experts from each of the FDA Product Centers, NIEHS/NTP, and the National Institutes of Health. 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 meeting of the TSSRC will be held November 9-10, 2016, at NCTR.
For additional information, please contact Paul Howard, Ph.D., Director, Office of Scientific Coordination, FDA/NCTR.
Commemorating Neurohistochemical Tracer Development
Dr. Larry Schmued outlined two of his inventions of novel histochemical tracers for the 50th Anniversary Issue of Brain Research. This issue of Brain Research features the most cited articles from their first 50 years of publishing. The manuscript describes two such tracers, specifically Fluoro-Gold and Fluoro-Jade C.
The Fluroro-Jade family of dyes represents several technical advancements for histochemical tracers significantly improving neuronal-detection sensitivity and selectivity that are used to detect axonal, dendritic and somatic degeneration/death axonal activity. The dyes are easy to use in practice and feature non-destructive, stable chemistry that provides opportunity for uses with other histochemical techniques to characterize neuroinflammation and neurotoxicity on the same slide.
Fluoro-Jade dyes have become an indispensable tool for academic scientists investigating neurotoxic mechanisms, and a well-accepted technology by industry often appearing in submissions as part of the Investigational New Drug application process.
For additional information, please contact Larry Schmued, Ph.D., Senior Research Scientist Head, Neurohistochemistry Laboratory, Division of Neurotoxicology, FDA/NCTR.