Rivulet Media Inc (fka RIVU)

[Krisandtilly]

A product that meets the requirements for general safety will
comply with the criteria found in Sec. 610.11(d) of the GST
regulation, i.e., injected animals survive the test period; they do not
exhibit any response that is not specific for or expected from the
product and which may indicate a difference in quality of the product;
and they weigh no less at the end of the test period than they did at
the time of injection.
While originally a useful approach, as time has passed, the Agency
has periodically explored the utility and efficiency of this approach.
In the Federal Register of May 14, 1996 (61 FR 24227), FDA published a
final rule exempting certain biotechnology-derived and synthetic
biological products from a number of regulations applicable to
biological products, including the GST (see Sec. 601.2(c)). This
action was in response to technical advances that greatly increased the
ability of manufacturers to control the manufacture of, and to more
fully analyze the physical and biological characteristics of, many
biotechnology-derived biological products.