When do intermediate stability studies need to be initiated in the event of failure at accelerated condition? 1.66K 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 loveAn ANDA applicant should start accelerated, intermediate, and long-term stability studies at the same time so the data are available at the time of submission if the accelerated stability study fails. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login