Replies to post #6687 on US Stem Cell Inc (USRM)

[Dragon Lady]

"That's the determining factor. "??

Would like to see a citation/quote from an FDA or other Euro regulatory handbook, operations manual or similar that emphatically, and clearly states that the main/primary criteria and only criteria for reviewing and then approving a new drug, med device or similar is, "Do the benefits out way the risks, PERIOD".

Didn't know that's why they take minimum 6 months, to often several yrs to approve a new drug/med device cause all they are looking for, searching for is "Do the benefits out way the risk, PERIOD"? (it's outweigh by the "way"). But never knew that? That's fascinating new info IMHO. Is this a new, published policy of the FDA or similar?

Links, copies of handbook, public statements by govt. bodies as to this clear and specific policy, etc all appreciated. Thanks in advance.