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BioChica

04/13/15 4:15 PM

#47527 RE: biowreck #47524

The FDA ADCOM system as a whole is a joke!

Members deciding on scientific issues on drug/device safety and efficacy in a short period of time. Kangaroo Court at best!

Panels are loaded with unqualified personnel! Should be some kind of scientific advisory panel!

Voting should be anonymous after discussion and review of scientific data? Since this vote is not binding on drug/device approval!

The FDA should be required to ask only two standard questions. The fact that they can fabricate questions on the fly is questionable!

1) Is the drug/device safe for humans?

2) Is the drug/device effective at accomplishing it's primary and secondary goal, set in the drug trial design?

3) Do the benefits out way the dangers?

The FDA should not have any input in the discussion! The decision should not be influenced by the FDA.