Two American manufacturers, the Westinghouse Electric Corporation and the General Electric Company, are designing advanced plants in work supported by the Government, and applying to the Nuclear Regulatory Commission for generic approval.
"What we need to do is get a regulatory pathway for generic biologic approval," said William H. Nixon, president of the Generic Pharmaceutical Association, which has about 150 members.
Ivan Razl of Adsoftheworld.com confirmed that these ads were removed against the rules of the website as the letter was only a generic approval and the said ads were not approved and the same was confirmed to him by JWT.
Such generic approvals are allowed while patents are still in force.
To provide timely consumer information on generic drugs, the Electronic Orange Book is updated daily as new generic approvals occur.
Moreover the new regulations made it clear that patents covering areas without direct therapeutic application, such as processes or intermediates, could not be used to delay generic approval.
Westinghouse and General Electric are both seeking generic approval for their designs from the Nuclear Regulatory Commission by 1995.
Lilly, too, suggests that clinical trials should be a prerequisite to generic approval.
(For more information on the first generic approvals, see http://www.fda.gov/cder/ogd/approvals/1stgen0506.htm).
There will be no generic approvals.