Replies to post #96191 on US Stem Cell Inc (USRM)

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I am betting $USRM wins, but if the FDA prevails in court, would the courts decision establish a "specific regulatory or statutory requirement"?

“FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA’s guidances means that something is suggested or recommended, but not required.”

The Answer is NO

Common Law is created by judicial action, through the decisions of courts or other tribunals. Statutory Law is created by legislative action, through the passing of Statutes. Regulatory Law is created by executive action, such as rules issued by agencies of the executive branch.

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