Replies to post #220653 on Elite Pharmaceuticals Inc (ELTP)

[bjoel5150]

FYI
regarding GDUFA date/timeline for review. Here is something more recent

"We’re now well into the second quarter of Fiscal Year 2015, which corresponds to GDUFA year 3 cohort applications. For that cohort, FDA agreed to review and act on 60% percent of original ANDAs within 15 months from the date of submission. (Those goals are ratcheted up in Fiscal Year 2016 [year 4 cohort] and Fiscal Year 2017 [year 5 cohort] where FDA agreed to review and act on 75% of original ANDAs within 15 months, and 90% of original ANDAs within 10 months, respectively.) GDUFA includes other performance goals for Fiscal Year 2015, including with respect to Prior Approval Supplements (“PASs”) and Controlled Correspondence."

link

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/02/we-need-to-move-the-freight-and-not-be-late-says-ogds-uhl-in-gdufa-update-but-for-many-in-industry-s.html

and

http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf