Are 6 months of stability data required on all three batches, or would one batch at 6 months and two lots at 3 months be acceptable? 1.35K 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 loveFollowing ICH stability guidances, 6 months accelerated stability data on all three submission batches should be provided. Spread the love Login