What is the scope of and implementation date for the FDA stability guidance? 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 loveThe FDA stability guidance covers all new ANDAs under the Federal Food, Drug, and Cosmetic Act, section 505 (j), and DMFs (Type II for drug substances that support the ANDAs). It does not apply to postapproval changes. Spread the love Login
