When a patent is due to shortly expire and there are no approved ANDAs, can we file with 3 months stability data with a commitment to supply 6 months data when available? 1.49K 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 loveNo. Data recommendations in the FDA stability guidance should be followed irrespective of patent status. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login
