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Re: FDA checks.....

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Connie, Jane, Bernard and All,

Jane and Bernard are correct - the FDA also checks on-site

manufacturing practices and standards. The paper work I

referred to (data audit), involves looking at the doctor's

records, (the doctors who are using a new drug that has

not yet been approved) to see if it works, and to document

side effects. The doctors are paid by the drug company to

do this.

Hope this clarifies, and in the future I will keep my big

mouth shut about this technical stuff I only know about

second hand!(Can we all say PISSED-OFF HUSBAND?)

ne, teacher

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OKAY,you are referring to audits of clinical trials for drugs in their first

development stages. This is true that clinicians who make these trials or

their organization may receive money from the drug companies. As a

consequence, the side effects reported for these new drugs are certainly not

overestimated, to say the least.

By this way of financing, my concern is that very efficient drugs having

less abililities to make big profits are slowly ignored even by

practitionners, for those drugs which enjoy from a generous marketing.

I think you have not to keep your mouth shut since it was an interesting

topic of discussion.

all the best wish you

Bernard, Switzerland

>

>... The paper work I

>referred to (data audit), involves looking at the doctor's

>records, (the doctors who are using a new drug that has

>not yet been approved) to see if it works, and to document

>side effects. The doctors are paid by the drug company to

>do this.

>Hope this clarifies, and in the future I will keep my big

>mouth shut about this technical stuff...

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Merci, Bernard!

It's hard for me to keep my mouth shut, anyway. You are a

welcome addition to our group - I think we need the broader

perspective of our European friends, especially one as

knowledgeable as you.

ne(teacher)

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