Cytodyn on the FDA SRO list March 19, 2021 http
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Posted On: 03/23/2021 4:11:05 PM
Cytodyn on the FDA SRO list March 19, 2021
https://www.accessdata.fda.gov/scripts/SDA/sd...p;rownum=1
read about the list here
https://www.fda.gov/about-fda/ethics/prohibit...-employees
"HHS Supplemental Standards of Ethical Conduct formally defines SRO as "an organization for which the sales of products regulated by the Food and Drug Administration (FDA) constitute ten percent or more of annual gross sales in the organization's previous fiscal year; 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."
"FDA employees as well as their spouse and minor children are prohibited from holding financial interests, like stock, in certain businesses regulated by FDA. This includes many companies working in the drug, biologic, medical device, food, and tobacco industries, among others."
"In large part, this restriction exists to help FDA employees avoid conflicts of interest under the criminal conflict of interest statute, 18 U.S.C. § 208. This law generally prohibits Federal employees from participating in any official matters that can have a direct and predictable effect on their financial interests or those imputed to them, including those of their spouse or minor children."
https://www.accessdata.fda.gov/scripts/SDA/sd...p;rownum=1
read about the list here
https://www.fda.gov/about-fda/ethics/prohibit...-employees
"HHS Supplemental Standards of Ethical Conduct formally defines SRO as "an organization for which the sales of products regulated by the Food and Drug Administration (FDA) constitute ten percent or more of annual gross sales in the organization's previous fiscal year; 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."
"FDA employees as well as their spouse and minor children are prohibited from holding financial interests, like stock, in certain businesses regulated by FDA. This includes many companies working in the drug, biologic, medical device, food, and tobacco industries, among others."
"In large part, this restriction exists to help FDA employees avoid conflicts of interest under the criminal conflict of interest statute, 18 U.S.C. § 208. This law generally prohibits Federal employees from participating in any official matters that can have a direct and predictable effect on their financial interests or those imputed to them, including those of their spouse or minor children."
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