Replies to post #113136 on Biotech Values

[alertmeipp]

those are examples but not limited to..

[DewDiligence]

That’s not an exhaustive list; the actual deficiency or deficiencies could be almost anything. Item #1 on your list, “deficiencies in the drug master file,” is itself a catchall for various kinds of deficiencies.

[ghmm]

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072888.pdf

Thanks to whomever posted the link (or post with the link) to the above. I think its worth reading for a better understanding. A couple of things make me wonder:
1-The document talks about deficiencies in the label as falling under the minor and some time ago TEVA mentioned labeling discussions (I believe late '09 but my memory isn't that great and who can keep track :-)). I thought we had the discussion on this board that this wouldn't be possible? If it would I am presuming that would mean its not fully substitutable?

2-On Page 4 B. When is an amendment redesignated?
Maybe its wishful thinking but could it just be the FDA is following the letter of the law so to speak and there is more to it but an initial communication falls under the minor? I am not that familiar with the ANDA process but as I recall ENCY got a Class 1 review on resubmission and ended up needing another trial (got 3 approvable letters).


EDIT:
Cleaned up ENCY review terminology and link added (below)
http://newsblaze.com/story/2006080704021200001.pz/topstory.html

[ThomasS]

4. Labeling deficiencies that have not been adequately addressed

Perhaps this dovetails with TEVA's prior comments regarding "labeling," whereas TEVA may get the non-substitutable version approved.