The FDA has updated and finalized its guidance “ANDA Submissions – Content and Format” (here). The 38-page document goes into even more detail than the previous drafts and provides expanded explanations for certain sections and requirements for documents.
There is advice for each eCTD section and even an expanded Cover Sheet format suggested in Appendix A of the document. It is worth spending time to carefully review this document and note changes to assist you better in making “first cycle” approvable ANDAs. This is good work from FDA and industry should place this in each and every industry representative’s hands before compiling an ANDA.
