O'Brien-Fleming spendinf function-Hodag | NWBO Message Board Posts


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Msg  16751 of 17216  at  9/22/2023 12:47:14 PM  by

Hodag


 In response to msg 16750 by  GaryM
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Re: O'Brien-Fleming spendinf function-Hodag

"I frankly don't believe the FDA will have to stretch there [sic] rules at all."
 
That is good, because there is absolutely no stretch permitted.  FDA has to make an affirmative finding that the drug is safe and effective for the intended indication.  That is not a point that is open for discussion; that is federal law and has been since the 1960's.
 
Science marches on, and knowledge accumulates, but the sponsor still has to make a strong argument that the drug is effective based on sound statistics that will allow the agency to make that determination.
 
BTW, I don't know why you think the regulators in other countries act differently than the FDA; they don't.  All the regulatory agencies speak frequently, and the answer to any question is likely to be the same in Rockville, Amsterdam, Canary Wharf, or Ottawa. 


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