FDA Lists NNLX on it's SRO List July 2020. Digg
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Posted On: 02/26/2021 10:40:23 PM
FDA Lists NNLX on it's SRO List July 2020.
Digging around on FDA's website tonight. Something interesting popped up tonight that didn't before. In July, 2020 Nanologix was added to it's Significantly Regulated Organizations (SRO). Standards of Ethical Conduct See 5 C.F.R. § 5501.101(c)(2).
Here is what that means. "...where an organization does not have a record of sales of FDA-regulated products, it will be deemed to be significantly regulated if its operations are predominately in fields regulated by FDA, or if its research, development, or other business activities are reasonably expected to result in the development of products that are regulated by FDA.
Interesting item to ponder.
Link to SRO definition
https://www.fda.gov/about-fda/ethics/signific...tions-sros
Link to July Listing
https://www.fda.gov/media/141398/download
Digging around on FDA's website tonight. Something interesting popped up tonight that didn't before. In July, 2020 Nanologix was added to it's Significantly Regulated Organizations (SRO). Standards of Ethical Conduct See 5 C.F.R. § 5501.101(c)(2).
Here is what that means. "...where an organization does not have a record of sales of FDA-regulated products, it will be deemed to be significantly regulated if its operations are predominately in fields regulated by FDA, or if its research, development, or other business activities are reasonably expected to result in the development of products that are regulated by FDA.
Interesting item to ponder.
Link to SRO definition
https://www.fda.gov/about-fda/ethics/signific...tions-sros
Link to July Listing
https://www.fda.gov/media/141398/download
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