Dendreon Corp fka DNDNQ

[rkcrules2001]

artavia2007...... cber vs cdrh .... you can ignore my prior question.

I just realized the link and text you posted regarding CR letters was from CDRH, focused on device PMAs. CBER is also listed on that site, but again I think the SOP is focused on devices, not biologics.

I think the pertinent CBER/biologics SOP may be:
http://www.fda.gov/cber/regsopp/8405.htm

There you will see a much simpler description, with no mention of "Major Deficiency" letters:


Action Letters

The following letter types constitute complete Agency actions (for performance goal and review clock purposes) in response to the application or supplement review process. Action letters are the result of complete Agency review of applications or supplements and stop the review clock.


Complete Response Letter - This letter will be issued when the complete review indicates that there are deficiencies remaining that preclude the approval of the application or supplement at that time. The Complete Response Letter will:

Summarize all of the deficiencies remaining, and
Where appropriate, describe actions necessary to place the application/supplement in a condition for approval.

Approval Letter - Following completion of all aspects of the review process, including testing of submitted product lots, pre-licensing inspection and evaluation of final printed labeling or a suitable alternative, an approval letter will constitute the final action.