Yes sir...that would be nice. But I read this part and thought it may be of benefit to us...
The second guidance clarifies current FDA policy on pre- and postmarket data collection. It explains situations in which postmarket data collection is appropriate for premarket approval (PMA) applications, both in EAP and non-EAP situations, and provides numerous examples.
Hell at this point in the game, I'm looking for any tiny kernel of hope from these FDA MF's!
It's just crazy how long they take to get anything done. "They" are NOT looking out for US citizens..."They" only care about coffee breaks, pension plans, holidays, vacations, employee unions, their own health benefits - paid by US tax payers, and kissing the bosses big fat arse!
damn I feel better now!
Cheers to you UK!
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