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Amatuer17

12/29/16 3:51 PM

#86024 RE: falconer66a #86023

Thanks - very interesting info.

That also shows why FDA insists on some large trials - not to just believe in what companies say or the very small trials (wink wink 32 patients).

"Fortunately, at the time, there was an FDA official, Frances Oldham Kelsey, who did not rely on information from the company. She single-handedly prevented thalidomide use in the US, even though FDA regulations were not as strict then. "
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GrassyKnoll

12/30/16 4:15 AM

#86079 RE: falconer66a #86023

My BFF dad was a bio statistician , the first PHD granted from Berkeley in the field. He loved to tell the story of visiting the FDA and seeing Ms. Kelsey's desk. It was piled high with folders and papers. He was convinced that the only reason that thalidomide did not get approved is because. It was stuck in the pile. On her desk.