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Re: eagle-eye post# 2705

Wednesday, 04/04/2007 11:53:27 PM

Wednesday, April 04, 2007 11:53:27 PM

Post# of 12660
Eagly eye: wrong on reasonable.

For safety, the word resoanble makes complete sence in that a drug that can save (or extend) lives can have more serious side effects that a minor pain reliever. "Reasoanble" means weight the drug risk vs. benfit.

For efficicy there is no such concept. Under law, the FDA must determine that there is reason to believe the drug does something (good). The question here is how certain, not the degree. Those rub on ointments for teneder joints have must meet the same efficicy requirement as a life saving drug.

I do agree with you in summary though, the FDA acted absolutely correctly in correcting the wordings, nothing is certain in this area.

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