is this what they call "pfufa" approval? in other words is there a formal approval still to go through? it seeems i see often in bios that they get a first approval from a board and then the final papers and demand have to be submitted which is usually a formaility? thx
Company submits a request for approval after completing phase 3 trials and if the FDA accepts the request they receive whats called a Prescription Drug User Fee Act date(PDUFA date) On that date they either get a denial, a CRL or a full approval. POZN got a full approval. Drug is cleared to market and sell. Hope that helps..there are no stupid questions.
and yes, you are referring to what some drugs go thru..which is an FDA advisory panel. And Im not sure why some drugs go thru this and some dont. Not sure what the critieria is for drugs that require a FDA advisory vote.