100% of Original ANDAs being submitted are in CTD format (eCTD+paper CTD+Gateway).
Approximately 95% (or more) of original submissions are now electronic.
Gateway submissions have continued to surge tremendously 58=(2008) 178=(2009) 411=(2010) 611=(2011).
RTR's as a percent of submissions is about 17% (data is incomplete as all of FY 2011 submissions have not been reviewed) FY 2008=15%, FY 2009=9%, FY 2010=14%.
FDA currently has approximately 2500 ANDA's under review.
FDA currently has approximately 4900 CMC Supplements under review.
To find more information click here: CUSTOpharmBlog: FDA eCTD ANDA Submission Statistics
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