FDA will issue complete response letters, rather than discipline specific letters, for all ANDAs, including those pending on October 1, 2012.

• Complete response letters will reflect full division-level review from all relevant review disciplines, including inspections, and other matters relating to the ANDA and associated DMFs as well as consults with other Agency components.
• FDA reviewers will make every reasonable effort to communicate promptly to applicants easily correctable deficiencies found in the ANDA.
• Reviewers will utilize an approach similar to the NDA review process whereby FDA uses telephone information requests to address easily correctable deficiencies during the review process before and after issuance of complete response letters.