Does all relevant CMC batch information for the three stability batches need to be included in the application? 1.61K viewsOctober 10, 2022FDA 0 Sam Smith11.38K November 2, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted November 2, 2020 0 Comments Spread the loveYes. When more than one lot of API or excipients is used, the corresponding section in Module 3 should contain appropriate CMC information. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login
