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I'm not so clued up on the FDA as I once was. But unless they have changed to rules; this is what occurs. Only one member of a small final committee has to say 'no' and it can't be passed. Although the distributor can again apply in just a couple of months

 

Now and again there is a committee member that puts a question-mark against a product. That is why the Thalidomide drug never went to the US. At least not officially. However some doctors in the system were given batches to use as an experiment.

 

The member who stood firm against Big Pharma back then, and I suspect others, was a lady named Frances Kelsea.

 

As I have said often enough on both AN and TT; the most important year of a child's life is the year before it is born. And the second most important year follows straight after.

 

Vioxx was withdrawn from the US market, after it was established that it had devastating side effects. OofC settlement of 5 billion dollars US, was paid into a fund for the drug victims.

 

None so blind as those who will not see.

 

 

 

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