How early should a company discuss with FDA the company strategy, rationale and what we consider to be an API starting material for filing? 1.59K viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K September 15, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted September 15, 2020 0 Comments Spread the loveQ7A does not address filing issues. However, you should meet with the review division as early as feasible, to get early input from the reviewers in defining the API starting materials. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login
