So, mal ganz nebenbei, BioV taucht nun auch für den Esel endlich bei der FDA auf und wurde zum Listing of Significantly Regulated Organizations (SRO) hinzugefügt.
-> https://www.fda.gov/media/150231/download
Wen interessiert, was das an sich unspektakuläres ist, nachfolgend Infos dazu. Ich find's positiv, ist es doch ein Zeichen dafür, dass sich eben die FDA tatsächlich mit BioV beschäftigt ;)
Who are restricted from holding financial interest in SROs?
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.
The restriction on holding financial interests in SROs is broad, applicable to interests in publicly traded, privately held companies, as well as certain sector funds that have a stated practice of concentrating its investments in SROs.
What is the SRO list?
To help employees determine whether or not an entity is considered to be an SRO, FDA maintains the List of Significantly Regulated Organizations (SROs). This is a searchable list of publicly-traded companies (traded on U.S. as well as foreign stock exchanges) that it has determined to meet the definition of an SRO.
The SRO list is a comprehensive and important resource to check regularly, however, it is not definitive. There are some situations where a financial interest may constitute a prohibited financial interest in an SRO, even if it is not included on the SRO List. For example, the SRO List does not include:
- Companies that are privately-held;
- Investments in private equity or hedge funds;
- Many new companies, for example those that may not have a record of sales of FDA regulated products, but which operate predominately in fields regulated by FDA
Quellen:
https://www.fda.gov/about-fda/ethics/...y-regulated-organizations-sro
https://www.fda.gov/about-fda/ethics/...ncial-interests-fda-employees |
