What will be the expected testing time points on accelerated conditions? 1.69K 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 loveThe applicant should test at 0 (initial release), 3, and 6 months; for additional time points on accelerated conditions, please follow ICH Q1A(R2) recommendations for all ANDAs. Spread the love Login
