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FDA Approval Process.     Co-E1®
/ NADH - Life's Energy Source
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FDA Approval Process: a list of facts
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The FDA approval process takes about 12 years and $359 million dollars to bring a new substance (vitamin or drug) to market. Of the 5,000 compounds that enter pre-clinical testing each year, only 5 will reach clinical trials and only 1 of these 5 will become FDA approved.Footnote 1 below

Lab tools used in expensive FDA testing procedures.Birkmayer Pharmaceuticals, the manufacturers of NADH / Co-E1®, is the first company following the rigorous and expensive testing procedures to demonstrate that a nutritional supplement, NADH / Co-E1® is effective in treating medical disorders. Co-E1® has reached the clinical trial stage. The clinical trials are progressing well.

Do you ask, "How come doctors prescribe expensive medications for treating medical disorders?" This is the reason: The expensive government approval process. This expense is passed on to the consumer. Consumers pay indirectly (funding the testing process) for each and every prescription written by a physician. So if we want our doctors to write prescriptions, we too have to carry the cost of the testing approval process.

We encourage other nutritional supplement companies to follow the Birkmayer Pharmaceuticals lead in following the rigorous and expensive testing procedures.

1. COPS Newsworthy Notes, September, 1996


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