The FDA does not publicly disclose if notices are given for: a) refusal to file for deficiencies, b) requests for more information, c) devices are not found not to be substantially equivalent, d)deficiencies in manufacturing facilities
It is up to the individual companies to disclose that to the public. Sometimes that company does, sometimes it doesn't. They will sometimes hide under the guise of "such-and-such" is still being reviewed by the FDA. I don't know whether or not that is an agreement between the FDA and individual companies, or if it's just the FDA protecting itself. The FDA will publicly disclose when an approval or clearance is given.
go re-read the posts you fkin dumbass. i was the one who said they DIDNT file an NDA of any kind, just to clarify what your reading comprehension skills lack. a non disclosure agreement in no way shape or form is significant to the shareholders (the reason we are on this board). its a simple term that can be used in MANY different situations. and ive never "suggested" that PDMI makes drugs, beacause they dont.
you are either mistaking what another poster said, or you're just a complete fuktard dip$hit jacka$s.
It can stand for both...Non disclosure agreement...also new drug application....but this company doesn't even have enough money to file their GD finacials.....let alone a new drug application...so I doubt that that's what it is....