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art2426

07/23/14 1:35 PM

#41345 RE: pennytiger #41344

>>The FDA has stated that it “has been reviewing these devices for many years, and their risks are
well known.” WE DISAGREE. A tiny percentage of adverse reactions are reported to the MAUDE
database, making it impossible to know how frequently adverse reactions occur.<<

Department or not, politely insulting and insinuating the incompetence of the FDA with statements as above is NOT going to positively affect or influence the FDA. I think BIEL found that out early in the approval process.

Simpsonly

07/23/14 5:43 PM

#41349 RE: pennytiger #41344

Nope, think you're correct penny - art was hustled by the fancy name - the Nat'l Center for Health Research used to be the Nat'l Research Center for Women and Families. Non-profit, non-whatever, sometimes such entities are non-everything. You were had art! Now I know why they changed their name - kching kching. I wonder if Diana Zuckerman even saw that letter sent to the FDA??? She's a pretty bright lady, but the letter seems off the mark in its bias.