Process for FDA approval

[Guest guest]

Now we can understand the complexity of getting LDN approved!

The overall process has four stages: I: Preclinical ResearchII: Clinical ResearchIII: FDA Review and ApprovalIV: MarketingThe first phase may be the one that was responsible for the unnecessary death that you mention in your note. In this phase, a formula is tested on healthy subjects that do not even have the illness that it is designed to remedy. Another noteworthy element of the process is that it is the formula's makers who conduct the testing -- and are responsible for turning over their results to the FDA for review and approval. With the formula's profit potential at stake, it's easy to see how this could lead to blatant conflicts of interest. It is during the second phase that most either make it or don't. That phase has four sub-stages -- and a formula's journey through those four sub-stages is monitored very closely by patent medicine companies, doctors, and even patients with illnesses who are hoping for something new to cure or relieve them. During the third phase, the FDA collects its massive paycheck from the company submitting its formula for review, opening the door even wider for more corruption and conflict of interest to enter the scene. This is the phase that prevents most natural therapies from ever gaining FDA-approval. Since they can't be patented, natural formulations don't have the same "return on investment" potential that synthetic formulas do. So even if the research behind a natural substance is solid, paying to have it approved just doesn't make financial sense to most companies, since they can't make back that money. That's also why many companies spend so much time trying to create synthetic versions of already-effective natural substances: There's just more money in it.The fourth phase is self-explanatory: This is when you begin seeing advertisements on TV and in magazines, and your doctor's office gets filled with free pens, clipboards, and notepads emblazoned with the formula's logo. To learn more about how the FDA works -- or how it's supposed to work, on paper anyway -- you can go to www.fda.gov and get it straight from the horse's mouth... and draw your own conclusions.

Joan, PACol. Potter's Cairn Rescue