FDA info #2
More goodies from the FDA web site:
Go to the following FDA website
fda.gov
I urge you to browse around , but make sure you look at the link "Benefit vs Risks: How the FDA Approves New Drugs".
There you will find the following:
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FDA participates actively in the drug development process, seeking to provide clear standards and expectations. Sponsors are encouraged to meet with FDA, Temple says, at an "end of phase 2 conference" before carrying out the large-scale controlled clinical trials. (For information about the various phases of drug study, see "Testing Drugs in People.") At this conference, FDA gives advice about the design of the sponsor's study plan to ensure that the trials will be acceptable.
As Temple puts it: "We try to find and eliminate flaws in the individual studies and overall development plan that we know will give us trouble later on in the NDA review. We don't want people to carry out a large study that has no chance of being considered adequate and well-controlled."
FDA also provides advice, he says, in the form of guidelines on how to study particular classes of drugs and on how to submit and analyze data in a marketing application.
In addition, to ensure that institutional review boards meet FDA's rules for the protection of the rights and welfare of research subjects, the agency routinely inspects the boards every five years. "We may go more often, if there are problems," says Frances O. Kelsey, Ph.D., M.D., director of FDA's division of scientific investigations.
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Now, how well does this description of the process fit with the accusations that the TXB Clinical trials were a sham, obfuscated, statistically insignificant, etc. How did TXB ever complete Phase III trials?
Once again, real information from - as Al Gore would say - "the controlling legal authority".
Or as I submit, from the horse's mouth, instead of ..... well... let's just say.... the other end of the horse. |
