What information about the nanomaterials the NCL characterizes does the NCL provide to the FDA?
A. As a formal collaboration between the National Cancer Institute (NCI), the National Institute of Standards and Technology (NIST), and the Food and Drug Administration (FDA), the NCL makes an effort to maintain transparency to its governing institutions. In that spirit, all NCL characterization data are available to the FDA. The NCL and FDA work together on many aspects of nanomaterial characterization, and the FDA is informed about the properties of NCL nanomaterials as data are being generated. Characterization data that appear in NCL reports are peer-reviewed by FDA scientists who serve on the NCL’s Scientific Oversight Committee (SOC). Biannually, NCL scientists formally present characterization information and data related to NCL nanomaterials to the NCL’s SOC, which includes representatives from the FDA. However, as mentioned previously, if an NCL sponsor initiates and files an IND with the FDA, the sponsor decides what NCL data are included in the IND and how the NCL inform
Related Questions
- Im studying nanomaterials but my application is not in the area of cancer. Can I still submit a proposal for characterization by the NCL?
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- What information about the nanomaterials the NCL characterizes does the NCL provide to the FDA?
